Trial Outcomes & Findings for Maximizing CRT Delivery by Using MultipolAr Coronary Sinus Lead FamiLy ACUITY® X4 - RALLY X4 Study (NCT NCT02066467)

NCT ID: NCT02066467

Last Updated: 2019-09-20

Results Overview

The Phrenic Nerve Stimulation (PNS) related Complication Free rate (CFR) through 6 months post-implant is defined as the rate of freedom from loss of function or operative system revision due to unacceptable PNS threshold

Recruitment status

COMPLETED

Target enrollment

863 participants

Primary outcome timeframe

6 months post-implant

Results posted on

2019-09-20

Participant Flow

The first subject was enrolled on 10 February 2014. The clinical phase of the study was completed on 30 September 2016 which was the date of the last subject's close-out visit. A total of 863 subjects across 82 centers were enrolled in the study in Europe, Asia and South America.

Participant milestones

Participant milestones
Measure	Heart Failure Patients * Subjects with heart failure who receive stable optimal pharmacologic therapy * Moderate to severe heart failure (NYHA Class III-IV) with ejection fraction (EF) ≤ 35% and QRS duration ≥ 120 ms * Left bundle branch block (LBBB) with QRS duration ≥ 130 ms, EF ≤ 30%, and mild (NYHA Class II) ischemic or non-ischemic heart failure or asymptomatic (NYHA Class I) ischemic heart failure. The study is collecting observational data on regular CRT-D device implants with special focus on the left ventricular ACUITY X4® Lead Family' . Left Ventricular lead implant: ACUITY X4® Lead Family: Implantation of (cardiac re-synchronization therapy with defibrillator) CRT-D devices for heartfailure treatment
Overall Study STARTED	863
Overall Study COMPLETED	648
Overall Study NOT COMPLETED	215

Reasons for withdrawal

Reasons for withdrawal
Measure	Heart Failure Patients * Subjects with heart failure who receive stable optimal pharmacologic therapy * Moderate to severe heart failure (NYHA Class III-IV) with ejection fraction (EF) ≤ 35% and QRS duration ≥ 120 ms * Left bundle branch block (LBBB) with QRS duration ≥ 130 ms, EF ≤ 30%, and mild (NYHA Class II) ischemic or non-ischemic heart failure or asymptomatic (NYHA Class I) ischemic heart failure. The study is collecting observational data on regular CRT-D device implants with special focus on the left ventricular ACUITY X4® Lead Family' . Left Ventricular lead implant: ACUITY X4® Lead Family: Implantation of (cardiac re-synchronization therapy with defibrillator) CRT-D devices for heartfailure treatment
Overall Study Did not undergo implant procedure	24
Overall Study Attempted to implant withoput success	43
Overall Study Consent ineligible	1
Overall Study Death	54
Overall Study Lost to Follow-up	51
Overall Study Adverse Event	20
Overall Study Withdrawal by Subject	16
Overall Study Physician Decision	2
Overall Study Not defined	4

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Heart Failure Patients n=863 Participants * Subjects with heart failure who receive stable optimal pharmacologic therapy * Moderate to severe heart failure (NYHA Class III-IV) with ejection fraction (EF) ≤ 35% and QRS duration ≥ 120 ms * Left bundle branch block (LBBB) with QRS duration ≥ 130 ms, EF ≤ 30%, and mild (NYHA Class II) ischemic or non-ischemic heart failure or asymptomatic (NYHA Class I) ischemic heart failure. The study is collecting observational data on regular CRT-D device implants with special focus on the left ventricular ACUITY X4® Lead Family' . Left Ventricular lead implant: ACUITY X4® Lead Family: Implantation of (cardiac re-synchronization therapy with defibrillator) CRT-D devices for heartfailure treatment
Age, Continuous	67.5 years STANDARD_DEVIATION 10.09 • n=863 Participants
Sex: Female, Male Female	189 Participants n=863 Participants
Sex: Female, Male Male	674 Participants n=863 Participants
Region of Enrollment Colombia	13 participants n=863 Participants
Region of Enrollment Singapore	18 participants n=863 Participants
Region of Enrollment Hong Kong	9 participants n=863 Participants
Region of Enrollment Japan	60 participants n=863 Participants
Region of Enrollment United Kingdom	38 participants n=863 Participants
Region of Enrollment Switzerland	31 participants n=863 Participants
Region of Enrollment Portugal	33 participants n=863 Participants
Region of Enrollment Spain	67 participants n=863 Participants
Region of Enrollment Austria	15 participants n=863 Participants
Region of Enrollment Netherlands	57 participants n=863 Participants
Region of Enrollment Belgium	5 participants n=863 Participants
Region of Enrollment Ireland	12 participants n=863 Participants
Region of Enrollment Finland	23 participants n=863 Participants
Region of Enrollment Denmark	30 participants n=863 Participants
Region of Enrollment Italy	124 participants n=863 Participants
Region of Enrollment Israel	47 participants n=863 Participants
Region of Enrollment France	119 participants n=863 Participants
Region of Enrollment Germany	162 participants n=863 Participants

PRIMARY outcome

Timeframe: 6 months post-implant

Population: 795 patients successfully implanted with ACUITY X4 lead

Outcome measures

Outcome measures
Measure	Heart Failure Patients n=795 Participants * Subjects with heart failure who receive stable optimal pharmacologic therapy * Moderate to severe heart failure (NYHA Class III-IV) with ejection fraction (EF) ≤ 35% and QRS duration ≥ 120 ms * Left bundle branch block (LBBB) with QRS duration ≥ 130 ms, EF ≤ 30%, and mild (NYHA Class II) ischemic or non-ischemic heart failure or asymptomatic (NYHA Class I) ischemic heart failure. The study is collecting observational data on regular CRT-D device implants with special focus on the left ventricular ACUITY X4® Lead Family' . Left Ventricular lead implant: ACUITY X4® Lead Family: Implantation of (cardiac re-synchronization therapy with defibrillator) CRT-D devices for heartfailure treatment
Phrenic Nerve Complication Free Rate	99.5 % of participants Interval 98.8 to 99.8

SECONDARY outcome

Timeframe: 3 months post-implant

Population: 795 patients successfully implanted with ACUITY X4 lead

Lead-related Complication-Free Rate (CFR) from implant through 3 months post-implant. Lead-related complications associated with the ACUITY X4® lead were counted towards this endpoint.

Outcome measures

Outcome measures
Measure	Heart Failure Patients n=795 Participants * Subjects with heart failure who receive stable optimal pharmacologic therapy * Moderate to severe heart failure (NYHA Class III-IV) with ejection fraction (EF) ≤ 35% and QRS duration ≥ 120 ms * Left bundle branch block (LBBB) with QRS duration ≥ 130 ms, EF ≤ 30%, and mild (NYHA Class II) ischemic or non-ischemic heart failure or asymptomatic (NYHA Class I) ischemic heart failure. The study is collecting observational data on regular CRT-D device implants with special focus on the left ventricular ACUITY X4® Lead Family' . Left Ventricular lead implant: ACUITY X4® Lead Family: Implantation of (cardiac re-synchronization therapy with defibrillator) CRT-D devices for heartfailure treatment
3 Month Lead-related Complication-Free Rate (CFR)	98.8 % of participants Interval 98.0 to 99.3

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 months post-implant

Population: At data cutoff date on 16 November 2015, 201 enrolled subjects met all of the PMCF eligibility criteria and were included in the analysis.

Post Market Clinical Follow-up (PMCF) of the ACUITY X4® lead was evaluated in this study. The outcome of interest is the 3 month implant success rate. The cohort of subjects included in this evaluation is the first 200 subjects to receive an ACUITY X4® lead implant and meet the PMCF eligibility criteria outlined below. The outcomes of interest for the PMCF supplemental analysis is the percent of subjects successfully implanted with an ACUITY X4® lead. Implant success is defined as the ability of the ACUITY X4® lead to be implanted and deliver CRT therapy. Subjects who have multiple lead implant attempts during the procedure, but are eventually successfully implanted with the ACUITY X4® lead and receive CRT therapy are classified as a successful implant.

Outcome measures

Outcome measures
Measure	Heart Failure Patients n=201 Participants * Subjects with heart failure who receive stable optimal pharmacologic therapy * Moderate to severe heart failure (NYHA Class III-IV) with ejection fraction (EF) ≤ 35% and QRS duration ≥ 120 ms * Left bundle branch block (LBBB) with QRS duration ≥ 130 ms, EF ≤ 30%, and mild (NYHA Class II) ischemic or non-ischemic heart failure or asymptomatic (NYHA Class I) ischemic heart failure. The study is collecting observational data on regular CRT-D device implants with special focus on the left ventricular ACUITY X4® Lead Family' . Left Ventricular lead implant: ACUITY X4® Lead Family: Implantation of (cardiac re-synchronization therapy with defibrillator) CRT-D devices for heartfailure treatment
3 Month Implant Success Rate for Indicated Subjects	99.5 % of participants Interval 97.7 to 100.0

Adverse Events

Heart Failure Patients

Serious events: 338 serious events

Other events: 452 other events

Deaths: 54 deaths

Serious adverse events

Serious adverse events
Measure	Heart Failure Patients n=838 participants at risk * Subjects with heart failure who receive stable optimal pharmacologic therapy * Moderate to severe heart failure (NYHA Class III-IV) with ejection fraction (EF) ≤ 35% and QRS duration ≥ 120 ms * Left bundle branch block (LBBB) with QRS duration ≥ 130 ms, EF ≤ 30%, and mild (NYHA Class II) ischemic or non-ischemic heart failure or asymptomatic (NYHA Class I) ischemic heart failure. The study is collecting observational data on regular CRT-D device implants with special focus on the left ventricular ACUITY X4® Lead Family' . Left Ventricular lead implant: ACUITY X4® Lead Family: Implantation of (cardiac re-synchronization therapy with defibrillator) CRT-D devices for heartfailure treatment
General disorders Abnormal laboratory values	0.24% 2/838 • Number of events 2 • Adverse events are collected from 1st enrollment through study completion (last subject's close-out visit) All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010 The number of participants at risk is defined as the subjects actively enrolled (838). Adverse events were not collected for subjects who did not undergo an implant procedure (24) and consent ineligible subjects (1).
General disorders Adverse reaction - Allergic reaction	0.12% 1/838 • Number of events 1 • Adverse events are collected from 1st enrollment through study completion (last subject's close-out visit) All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010 The number of participants at risk is defined as the subjects actively enrolled (838). Adverse events were not collected for subjects who did not undergo an implant procedure (24) and consent ineligible subjects (1).
General disorders Adverse reaction - Hypotension	0.12% 1/838 • Number of events 1 • Adverse events are collected from 1st enrollment through study completion (last subject's close-out visit) All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010 The number of participants at risk is defined as the subjects actively enrolled (838). Adverse events were not collected for subjects who did not undergo an implant procedure (24) and consent ineligible subjects (1).
Cardiac disorders Aortic regurgitation	0.12% 1/838 • Number of events 1 • Adverse events are collected from 1st enrollment through study completion (last subject's close-out visit) All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010 The number of participants at risk is defined as the subjects actively enrolled (838). Adverse events were not collected for subjects who did not undergo an implant procedure (24) and consent ineligible subjects (1).
Cardiac disorders Aortic stenosis	0.12% 1/838 • Number of events 1 • Adverse events are collected from 1st enrollment through study completion (last subject's close-out visit) All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010 The number of participants at risk is defined as the subjects actively enrolled (838). Adverse events were not collected for subjects who did not undergo an implant procedure (24) and consent ineligible subjects (1).
Vascular disorders Arterial/venous thrombolytic event	0.12% 1/838 • Number of events 1 • Adverse events are collected from 1st enrollment through study completion (last subject's close-out visit) All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010 The number of participants at risk is defined as the subjects actively enrolled (838). Adverse events were not collected for subjects who did not undergo an implant procedure (24) and consent ineligible subjects (1).
Cardiac disorders Atrial fibrillation (AF)	4.9% 41/838 • Number of events 46 • Adverse events are collected from 1st enrollment through study completion (last subject's close-out visit) All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010 The number of participants at risk is defined as the subjects actively enrolled (838). Adverse events were not collected for subjects who did not undergo an implant procedure (24) and consent ineligible subjects (1).
Cardiac disorders Atrial flutter	1.2% 10/838 • Number of events 11 • Adverse events are collected from 1st enrollment through study completion (last subject's close-out visit) All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010 The number of participants at risk is defined as the subjects actively enrolled (838). Adverse events were not collected for subjects who did not undergo an implant procedure (24) and consent ineligible subjects (1).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer	0.95% 8/838 • Number of events 9 • Adverse events are collected from 1st enrollment through study completion (last subject's close-out visit) All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010 The number of participants at risk is defined as the subjects actively enrolled (838). Adverse events were not collected for subjects who did not undergo an implant procedure (24) and consent ineligible subjects (1).
Cardiac disorders Cardiac arrest	0.36% 3/838 • Number of events 3 • Adverse events are collected from 1st enrollment through study completion (last subject's close-out visit) All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010 The number of participants at risk is defined as the subjects actively enrolled (838). Adverse events were not collected for subjects who did not undergo an implant procedure (24) and consent ineligible subjects (1).
Cardiac disorders Cardiogenic shock	0.48% 4/838 • Number of events 5 • Adverse events are collected from 1st enrollment through study completion (last subject's close-out visit) All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010 The number of participants at risk is defined as the subjects actively enrolled (838). Adverse events were not collected for subjects who did not undergo an implant procedure (24) and consent ineligible subjects (1).
Cardiac disorders Cerebrovascular accident (CVA)	0.60% 5/838 • Number of events 5 • Adverse events are collected from 1st enrollment through study completion (last subject's close-out visit) All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010 The number of participants at risk is defined as the subjects actively enrolled (838). Adverse events were not collected for subjects who did not undergo an implant procedure (24) and consent ineligible subjects (1).
Cardiac disorders Chest pain - Ischemic	0.60% 5/838 • Number of events 6 • Adverse events are collected from 1st enrollment through study completion (last subject's close-out visit) All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010 The number of participants at risk is defined as the subjects actively enrolled (838). Adverse events were not collected for subjects who did not undergo an implant procedure (24) and consent ineligible subjects (1).
Cardiac disorders Chest pain - Other	0.72% 6/838 • Number of events 7 • Adverse events are collected from 1st enrollment through study completion (last subject's close-out visit) All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010 The number of participants at risk is defined as the subjects actively enrolled (838). Adverse events were not collected for subjects who did not undergo an implant procedure (24) and consent ineligible subjects (1).
Respiratory, thoracic and mediastinal disorders COPD exacerbation	0.12% 1/838 • Number of events 2 • Adverse events are collected from 1st enrollment through study completion (last subject's close-out visit) All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010 The number of participants at risk is defined as the subjects actively enrolled (838). Adverse events were not collected for subjects who did not undergo an implant procedure (24) and consent ineligible subjects (1).
Cardiac disorders Coronary Artery Disease	0.72% 6/838 • Number of events 6 • Adverse events are collected from 1st enrollment through study completion (last subject's close-out visit) All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010 The number of participants at risk is defined as the subjects actively enrolled (838). Adverse events were not collected for subjects who did not undergo an implant procedure (24) and consent ineligible subjects (1).
Surgical and medical procedures Coronary venous dissection	0.12% 1/838 • Number of events 1 • Adverse events are collected from 1st enrollment through study completion (last subject's close-out visit) All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010 The number of participants at risk is defined as the subjects actively enrolled (838). Adverse events were not collected for subjects who did not undergo an implant procedure (24) and consent ineligible subjects (1).
General disorders Death	1.6% 13/838 • Number of events 13 • Adverse events are collected from 1st enrollment through study completion (last subject's close-out visit) All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010 The number of participants at risk is defined as the subjects actively enrolled (838). Adverse events were not collected for subjects who did not undergo an implant procedure (24) and consent ineligible subjects (1).
Product Issues Device Deficiency	0.12% 1/838 • Number of events 1 • Adverse events are collected from 1st enrollment through study completion (last subject's close-out visit) All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010 The number of participants at risk is defined as the subjects actively enrolled (838). Adverse events were not collected for subjects who did not undergo an implant procedure (24) and consent ineligible subjects (1).
Product Issues Dislodgment - Elevated threshold - LV	0.12% 1/838 • Number of events 1 • Adverse events are collected from 1st enrollment through study completion (last subject's close-out visit) All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010 The number of participants at risk is defined as the subjects actively enrolled (838). Adverse events were not collected for subjects who did not undergo an implant procedure (24) and consent ineligible subjects (1).
Product Issues Dislodgment - Extracardiac stimulation- LV	0.24% 2/838 • Number of events 2 • Adverse events are collected from 1st enrollment through study completion (last subject's close-out visit) All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010 The number of participants at risk is defined as the subjects actively enrolled (838). Adverse events were not collected for subjects who did not undergo an implant procedure (24) and consent ineligible subjects (1).
Product Issues Dislodgment - Multiple signs - LV	0.12% 1/838 • Number of events 1 • Adverse events are collected from 1st enrollment through study completion (last subject's close-out visit) All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010 The number of participants at risk is defined as the subjects actively enrolled (838). Adverse events were not collected for subjects who did not undergo an implant procedure (24) and consent ineligible subjects (1).
Product Issues Dislodgment - No reported signs - RA	0.48% 4/838 • Number of events 4 • Adverse events are collected from 1st enrollment through study completion (last subject's close-out visit) All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010 The number of participants at risk is defined as the subjects actively enrolled (838). Adverse events were not collected for subjects who did not undergo an implant procedure (24) and consent ineligible subjects (1).
Product Issues Dislodgment - No reported signs - RV	0.36% 3/838 • Number of events 3 • Adverse events are collected from 1st enrollment through study completion (last subject's close-out visit) All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010 The number of participants at risk is defined as the subjects actively enrolled (838). Adverse events were not collected for subjects who did not undergo an implant procedure (24) and consent ineligible subjects (1).
Product Issues Dislodgment - No reported signs -LV	0.24% 2/838 • Number of events 2 • Adverse events are collected from 1st enrollment through study completion (last subject's close-out visit) All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010 The number of participants at risk is defined as the subjects actively enrolled (838). Adverse events were not collected for subjects who did not undergo an implant procedure (24) and consent ineligible subjects (1).
Product Issues Dislodgment - Unable to capture - LV	0.24% 2/838 • Number of events 2 • Adverse events are collected from 1st enrollment through study completion (last subject's close-out visit) All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010 The number of participants at risk is defined as the subjects actively enrolled (838). Adverse events were not collected for subjects who did not undergo an implant procedure (24) and consent ineligible subjects (1).
Product Issues Dislodgment - Unable to capture - RA	0.12% 1/838 • Number of events 1 • Adverse events are collected from 1st enrollment through study completion (last subject's close-out visit) All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010 The number of participants at risk is defined as the subjects actively enrolled (838). Adverse events were not collected for subjects who did not undergo an implant procedure (24) and consent ineligible subjects (1).
Product Issues Dislodgment - Unable to capture - RV	0.24% 2/838 • Number of events 2 • Adverse events are collected from 1st enrollment through study completion (last subject's close-out visit) All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010 The number of participants at risk is defined as the subjects actively enrolled (838). Adverse events were not collected for subjects who did not undergo an implant procedure (24) and consent ineligible subjects (1).
Cardiac disorders Distal thromboemboli	0.12% 1/838 • Number of events 1 • Adverse events are collected from 1st enrollment through study completion (last subject's close-out visit) All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010 The number of participants at risk is defined as the subjects actively enrolled (838). Adverse events were not collected for subjects who did not undergo an implant procedure (24) and consent ineligible subjects (1).
Cardiac disorders Dizziness	0.12% 1/838 • Number of events 1 • Adverse events are collected from 1st enrollment through study completion (last subject's close-out visit) All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010 The number of participants at risk is defined as the subjects actively enrolled (838). Adverse events were not collected for subjects who did not undergo an implant procedure (24) and consent ineligible subjects (1).
Cardiac disorders Dyspnea	0.36% 3/838 • Number of events 3 • Adverse events are collected from 1st enrollment through study completion (last subject's close-out visit) All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010 The number of participants at risk is defined as the subjects actively enrolled (838). Adverse events were not collected for subjects who did not undergo an implant procedure (24) and consent ineligible subjects (1).
Cardiac disorders Dyspnea - Heart failure	1.1% 9/838 • Number of events 11 • Adverse events are collected from 1st enrollment through study completion (last subject's close-out visit) All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010 The number of participants at risk is defined as the subjects actively enrolled (838). Adverse events were not collected for subjects who did not undergo an implant procedure (24) and consent ineligible subjects (1).
Product Issues Elevated threshold - LV	0.48% 4/838 • Number of events 4 • Adverse events are collected from 1st enrollment through study completion (last subject's close-out visit) All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010 The number of participants at risk is defined as the subjects actively enrolled (838). Adverse events were not collected for subjects who did not undergo an implant procedure (24) and consent ineligible subjects (1).
Product Issues Elevated threshold - RV	0.24% 2/838 • Number of events 2 • Adverse events are collected from 1st enrollment through study completion (last subject's close-out visit) All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010 The number of participants at risk is defined as the subjects actively enrolled (838). Adverse events were not collected for subjects who did not undergo an implant procedure (24) and consent ineligible subjects (1).
Endocrine disorders Endocrine	0.36% 3/838 • Number of events 3 • Adverse events are collected from 1st enrollment through study completion (last subject's close-out visit) All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010 The number of participants at risk is defined as the subjects actively enrolled (838). Adverse events were not collected for subjects who did not undergo an implant procedure (24) and consent ineligible subjects (1).
Product Issues Erosion	0.12% 1/838 • Number of events 1 • Adverse events are collected from 1st enrollment through study completion (last subject's close-out visit) All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010 The number of participants at risk is defined as the subjects actively enrolled (838). Adverse events were not collected for subjects who did not undergo an implant procedure (24) and consent ineligible subjects (1).
Product Issues Extracardiac stimulation - LV	0.48% 4/838 • Number of events 4 • Adverse events are collected from 1st enrollment through study completion (last subject's close-out visit) All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010 The number of participants at risk is defined as the subjects actively enrolled (838). Adverse events were not collected for subjects who did not undergo an implant procedure (24) and consent ineligible subjects (1).
Product Issues Extracardiac stimulation - RV	0.12% 1/838 • Number of events 1 • Adverse events are collected from 1st enrollment through study completion (last subject's close-out visit) All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010 The number of participants at risk is defined as the subjects actively enrolled (838). Adverse events were not collected for subjects who did not undergo an implant procedure (24) and consent ineligible subjects (1).
Cardiac disorders Fatigue	0.12% 1/838 • Number of events 1 • Adverse events are collected from 1st enrollment through study completion (last subject's close-out visit) All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010 The number of participants at risk is defined as the subjects actively enrolled (838). Adverse events were not collected for subjects who did not undergo an implant procedure (24) and consent ineligible subjects (1).
Infections and infestations Fever	0.24% 2/838 • Number of events 2 • Adverse events are collected from 1st enrollment through study completion (last subject's close-out visit) All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010 The number of participants at risk is defined as the subjects actively enrolled (838). Adverse events were not collected for subjects who did not undergo an implant procedure (24) and consent ineligible subjects (1).
Gastrointestinal disorders Gastrointestinal	2.4% 20/838 • Number of events 24 • Adverse events are collected from 1st enrollment through study completion (last subject's close-out visit) All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010 The number of participants at risk is defined as the subjects actively enrolled (838). Adverse events were not collected for subjects who did not undergo an implant procedure (24) and consent ineligible subjects (1).
Reproductive system and breast disorders Genitourinary	0.48% 4/838 • Number of events 5 • Adverse events are collected from 1st enrollment through study completion (last subject's close-out visit) All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010 The number of participants at risk is defined as the subjects actively enrolled (838). Adverse events were not collected for subjects who did not undergo an implant procedure (24) and consent ineligible subjects (1).
General disorders Head, eyes, ears, nose, throat (HEENT)	1.2% 10/838 • Number of events 11 • Adverse events are collected from 1st enrollment through study completion (last subject's close-out visit) All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010 The number of participants at risk is defined as the subjects actively enrolled (838). Adverse events were not collected for subjects who did not undergo an implant procedure (24) and consent ineligible subjects (1).
Cardiac disorders Heart failure symptoms - Unspecified	5.8% 49/838 • Number of events 56 • Adverse events are collected from 1st enrollment through study completion (last subject's close-out visit) All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010 The number of participants at risk is defined as the subjects actively enrolled (838). Adverse events were not collected for subjects who did not undergo an implant procedure (24) and consent ineligible subjects (1).
Blood and lymphatic system disorders Hematological	0.48% 4/838 • Number of events 5 • Adverse events are collected from 1st enrollment through study completion (last subject's close-out visit) All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010 The number of participants at risk is defined as the subjects actively enrolled (838). Adverse events were not collected for subjects who did not undergo an implant procedure (24) and consent ineligible subjects (1).
Surgical and medical procedures Hematoma - Pocket (<= 30 days post-implant)	0.95% 8/838 • Number of events 8 • Adverse events are collected from 1st enrollment through study completion (last subject's close-out visit) All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010 The number of participants at risk is defined as the subjects actively enrolled (838). Adverse events were not collected for subjects who did not undergo an implant procedure (24) and consent ineligible subjects (1).
Cardiac disorders Hypertension	0.12% 1/838 • Number of events 1 • Adverse events are collected from 1st enrollment through study completion (last subject's close-out visit) All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010 The number of participants at risk is defined as the subjects actively enrolled (838). Adverse events were not collected for subjects who did not undergo an implant procedure (24) and consent ineligible subjects (1).
Cardiac disorders Hypotension	0.12% 1/838 • Number of events 1 • Adverse events are collected from 1st enrollment through study completion (last subject's close-out visit) All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010 The number of participants at risk is defined as the subjects actively enrolled (838). Adverse events were not collected for subjects who did not undergo an implant procedure (24) and consent ineligible subjects (1).
Immune system disorders Immune	0.24% 2/838 • Number of events 2 • Adverse events are collected from 1st enrollment through study completion (last subject's close-out visit) All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010 The number of participants at risk is defined as the subjects actively enrolled (838). Adverse events were not collected for subjects who did not undergo an implant procedure (24) and consent ineligible subjects (1).
Product Issues Impedance > 2000 ohms - LV	0.12% 1/838 • Number of events 1 • Adverse events are collected from 1st enrollment through study completion (last subject's close-out visit) All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010 The number of participants at risk is defined as the subjects actively enrolled (838). Adverse events were not collected for subjects who did not undergo an implant procedure (24) and consent ineligible subjects (1).
Product Issues Inappropriate tachy therapy - Noise	0.12% 1/838 • Number of events 1 • Adverse events are collected from 1st enrollment through study completion (last subject's close-out visit) All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010 The number of participants at risk is defined as the subjects actively enrolled (838). Adverse events were not collected for subjects who did not undergo an implant procedure (24) and consent ineligible subjects (1).
Product Issues Inappropriate tachy therapy - Other	0.12% 1/838 • Number of events 1 • Adverse events are collected from 1st enrollment through study completion (last subject's close-out visit) All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010 The number of participants at risk is defined as the subjects actively enrolled (838). Adverse events were not collected for subjects who did not undergo an implant procedure (24) and consent ineligible subjects (1).
Product Issues Inappropriate tachy therapy - SVT	0.72% 6/838 • Number of events 6 • Adverse events are collected from 1st enrollment through study completion (last subject's close-out visit) All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010 The number of participants at risk is defined as the subjects actively enrolled (838). Adverse events were not collected for subjects who did not undergo an implant procedure (24) and consent ineligible subjects (1).
Product Issues Inappropriate tachy therapy- NSR	0.12% 1/838 • Number of events 1 • Adverse events are collected from 1st enrollment through study completion (last subject's close-out visit) All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010 The number of participants at risk is defined as the subjects actively enrolled (838). Adverse events were not collected for subjects who did not undergo an implant procedure (24) and consent ineligible subjects (1).
Product Issues Infection (> 30 days post-implant)	1.2% 10/838 • Number of events 10 • Adverse events are collected from 1st enrollment through study completion (last subject's close-out visit) All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010 The number of participants at risk is defined as the subjects actively enrolled (838). Adverse events were not collected for subjects who did not undergo an implant procedure (24) and consent ineligible subjects (1).
Skin and subcutaneous tissue disorders Integumentary	0.72% 6/838 • Number of events 8 • Adverse events are collected from 1st enrollment through study completion (last subject's close-out visit) All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010 The number of participants at risk is defined as the subjects actively enrolled (838). Adverse events were not collected for subjects who did not undergo an implant procedure (24) and consent ineligible subjects (1).
General disorders Intermittent Claudication	0.12% 1/838 • Number of events 1 • Adverse events are collected from 1st enrollment through study completion (last subject's close-out visit) All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010 The number of participants at risk is defined as the subjects actively enrolled (838). Adverse events were not collected for subjects who did not undergo an implant procedure (24) and consent ineligible subjects (1).
Cardiac disorders Mitral regurgitation	0.24% 2/838 • Number of events 2 • Adverse events are collected from 1st enrollment through study completion (last subject's close-out visit) All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010 The number of participants at risk is defined as the subjects actively enrolled (838). Adverse events were not collected for subjects who did not undergo an implant procedure (24) and consent ineligible subjects (1).
Cardiac disorders Mitral stenosis	0.12% 1/838 • Number of events 1 • Adverse events are collected from 1st enrollment through study completion (last subject's close-out visit) All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010 The number of participants at risk is defined as the subjects actively enrolled (838). Adverse events were not collected for subjects who did not undergo an implant procedure (24) and consent ineligible subjects (1).
Cardiac disorders Multiple heart failure symptoms	1.1% 9/838 • Number of events 10 • Adverse events are collected from 1st enrollment through study completion (last subject's close-out visit) All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010 The number of participants at risk is defined as the subjects actively enrolled (838). Adverse events were not collected for subjects who did not undergo an implant procedure (24) and consent ineligible subjects (1).
General disorders Multi-system failure	0.36% 3/838 • Number of events 3 • Adverse events are collected from 1st enrollment through study completion (last subject's close-out visit) All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010 The number of participants at risk is defined as the subjects actively enrolled (838). Adverse events were not collected for subjects who did not undergo an implant procedure (24) and consent ineligible subjects (1).
Cardiac disorders Multi-system failure - Heart failure	0.60% 5/838 • Number of events 5 • Adverse events are collected from 1st enrollment through study completion (last subject's close-out visit) All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010 The number of participants at risk is defined as the subjects actively enrolled (838). Adverse events were not collected for subjects who did not undergo an implant procedure (24) and consent ineligible subjects (1).
Musculoskeletal and connective tissue disorders Musculoskeletal	1.1% 9/838 • Number of events 10 • Adverse events are collected from 1st enrollment through study completion (last subject's close-out visit) All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010 The number of participants at risk is defined as the subjects actively enrolled (838). Adverse events were not collected for subjects who did not undergo an implant procedure (24) and consent ineligible subjects (1).
Cardiac disorders Myocardial infarction	0.36% 3/838 • Number of events 3 • Adverse events are collected from 1st enrollment through study completion (last subject's close-out visit) All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010 The number of participants at risk is defined as the subjects actively enrolled (838). Adverse events were not collected for subjects who did not undergo an implant procedure (24) and consent ineligible subjects (1).
Product Issues Myocardial perforation post-implant - RA	0.12% 1/838 • Number of events 1 • Adverse events are collected from 1st enrollment through study completion (last subject's close-out visit) All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010 The number of participants at risk is defined as the subjects actively enrolled (838). Adverse events were not collected for subjects who did not undergo an implant procedure (24) and consent ineligible subjects (1).
Product Issues Myocardial perforation post-implant - RV	0.48% 4/838 • Number of events 4 • Adverse events are collected from 1st enrollment through study completion (last subject's close-out visit) All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010 The number of participants at risk is defined as the subjects actively enrolled (838). Adverse events were not collected for subjects who did not undergo an implant procedure (24) and consent ineligible subjects (1).
Surgical and medical procedures Myocardial perforation with tamponade	0.12% 1/838 • Number of events 1 • Adverse events are collected from 1st enrollment through study completion (last subject's close-out visit) All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010 The number of participants at risk is defined as the subjects actively enrolled (838). Adverse events were not collected for subjects who did not undergo an implant procedure (24) and consent ineligible subjects (1).
Surgical and medical procedures Myocardial perforation without tamponade	0.12% 1/838 • Number of events 1 • Adverse events are collected from 1st enrollment through study completion (last subject's close-out visit) All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010 The number of participants at risk is defined as the subjects actively enrolled (838). Adverse events were not collected for subjects who did not undergo an implant procedure (24) and consent ineligible subjects (1).
Nervous system disorders Neurological	0.36% 3/838 • Number of events 3 • Adverse events are collected from 1st enrollment through study completion (last subject's close-out visit) All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010 The number of participants at risk is defined as the subjects actively enrolled (838). Adverse events were not collected for subjects who did not undergo an implant procedure (24) and consent ineligible subjects (1).
Cardiac disorders Nonsustained ventricular tachycardia (NSVT)	0.24% 2/838 • Number of events 2 • Adverse events are collected from 1st enrollment through study completion (last subject's close-out visit) All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010 The number of participants at risk is defined as the subjects actively enrolled (838). Adverse events were not collected for subjects who did not undergo an implant procedure (24) and consent ineligible subjects (1).
Product Issues Other - Lead	0.84% 7/838 • Number of events 7 • Adverse events are collected from 1st enrollment through study completion (last subject's close-out visit) All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010 The number of participants at risk is defined as the subjects actively enrolled (838). Adverse events were not collected for subjects who did not undergo an implant procedure (24) and consent ineligible subjects (1).
Surgical and medical procedures Other - Lead - Procedure	1.1% 9/838 • Number of events 9 • Adverse events are collected from 1st enrollment through study completion (last subject's close-out visit) All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010 The number of participants at risk is defined as the subjects actively enrolled (838). Adverse events were not collected for subjects who did not undergo an implant procedure (24) and consent ineligible subjects (1).
Product Issues Other - PG system	0.12% 1/838 • Number of events 1 • Adverse events are collected from 1st enrollment through study completion (last subject's close-out visit) All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010 The number of participants at risk is defined as the subjects actively enrolled (838). Adverse events were not collected for subjects who did not undergo an implant procedure (24) and consent ineligible subjects (1).
Surgical and medical procedures Other - PG system - Procedure	0.24% 2/838 • Number of events 2 • Adverse events are collected from 1st enrollment through study completion (last subject's close-out visit) All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010 The number of participants at risk is defined as the subjects actively enrolled (838). Adverse events were not collected for subjects who did not undergo an implant procedure (24) and consent ineligible subjects (1).
Cardiac disorders Other- Heart failure patient condition - Cardiovascular	1.2% 10/838 • Number of events 12 • Adverse events are collected from 1st enrollment through study completion (last subject's close-out visit) All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010 The number of participants at risk is defined as the subjects actively enrolled (838). Adverse events were not collected for subjects who did not undergo an implant procedure (24) and consent ineligible subjects (1).
General disorders Other- Patient condition - Non- cardiovascular	0.48% 4/838 • Number of events 4 • Adverse events are collected from 1st enrollment through study completion (last subject's close-out visit) All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010 The number of participants at risk is defined as the subjects actively enrolled (838). Adverse events were not collected for subjects who did not undergo an implant procedure (24) and consent ineligible subjects (1).
Cardiac disorders Other SVT (eg AVRT, AVNRT, EAT)	0.60% 5/838 • Number of events 5 • Adverse events are collected from 1st enrollment through study completion (last subject's close-out visit) All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010 The number of participants at risk is defined as the subjects actively enrolled (838). Adverse events were not collected for subjects who did not undergo an implant procedure (24) and consent ineligible subjects (1).
Product Issues Oversensing - RV	0.12% 1/838 • Number of events 1 • Adverse events are collected from 1st enrollment through study completion (last subject's close-out visit) All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010 The number of participants at risk is defined as the subjects actively enrolled (838). Adverse events were not collected for subjects who did not undergo an implant procedure (24) and consent ineligible subjects (1).
Product Issues Pacemaker-mediated tachycardia (PMT)	0.12% 1/838 • Number of events 1 • Adverse events are collected from 1st enrollment through study completion (last subject's close-out visit) All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010 The number of participants at risk is defined as the subjects actively enrolled (838). Adverse events were not collected for subjects who did not undergo an implant procedure (24) and consent ineligible subjects (1).
Cardiac disorders Palpitations	0.24% 2/838 • Number of events 2 • Adverse events are collected from 1st enrollment through study completion (last subject's close-out visit) All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010 The number of participants at risk is defined as the subjects actively enrolled (838). Adverse events were not collected for subjects who did not undergo an implant procedure (24) and consent ineligible subjects (1).
Cardiac disorders Pericardial effusion	0.36% 3/838 • Number of events 3 • Adverse events are collected from 1st enrollment through study completion (last subject's close-out visit) All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010 The number of participants at risk is defined as the subjects actively enrolled (838). Adverse events were not collected for subjects who did not undergo an implant procedure (24) and consent ineligible subjects (1).
Cardiac disorders Peripheral edema - Heart failure	0.12% 1/838 • Number of events 1 • Adverse events are collected from 1st enrollment through study completion (last subject's close-out visit) All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010 The number of participants at risk is defined as the subjects actively enrolled (838). Adverse events were not collected for subjects who did not undergo an implant procedure (24) and consent ineligible subjects (1).
Cardiac disorders Peripheral vascular disease	0.72% 6/838 • Number of events 6 • Adverse events are collected from 1st enrollment through study completion (last subject's close-out visit) All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010 The number of participants at risk is defined as the subjects actively enrolled (838). Adverse events were not collected for subjects who did not undergo an implant procedure (24) and consent ineligible subjects (1).
General disorders Physical trauma	0.60% 5/838 • Number of events 5 • Adverse events are collected from 1st enrollment through study completion (last subject's close-out visit) All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010 The number of participants at risk is defined as the subjects actively enrolled (838). Adverse events were not collected for subjects who did not undergo an implant procedure (24) and consent ineligible subjects (1).
Surgical and medical procedures Pleural effusion - Procedure	0.12% 1/838 • Number of events 1 • Adverse events are collected from 1st enrollment through study completion (last subject's close-out visit) All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010 The number of participants at risk is defined as the subjects actively enrolled (838). Adverse events were not collected for subjects who did not undergo an implant procedure (24) and consent ineligible subjects (1).
Surgical and medical procedures Pneumothorax - Procedure	0.72% 6/838 • Number of events 6 • Adverse events are collected from 1st enrollment through study completion (last subject's close-out visit) All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010 The number of participants at risk is defined as the subjects actively enrolled (838). Adverse events were not collected for subjects who did not undergo an implant procedure (24) and consent ineligible subjects (1).
Surgical and medical procedures Post-surgical infection (<= 30 days post-implant)	0.84% 7/838 • Number of events 8 • Adverse events are collected from 1st enrollment through study completion (last subject's close-out visit) All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010 The number of participants at risk is defined as the subjects actively enrolled (838). Adverse events were not collected for subjects who did not undergo an implant procedure (24) and consent ineligible subjects (1).
Surgical and medical procedures Post-surgical pocket hemorrhage	0.24% 2/838 • Number of events 2 • Adverse events are collected from 1st enrollment through study completion (last subject's close-out visit) All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010 The number of participants at risk is defined as the subjects actively enrolled (838). Adverse events were not collected for subjects who did not undergo an implant procedure (24) and consent ineligible subjects (1).
Surgical and medical procedures Post-surgical wound discomfort	0.12% 1/838 • Number of events 1 • Adverse events are collected from 1st enrollment through study completion (last subject's close-out visit) All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010 The number of participants at risk is defined as the subjects actively enrolled (838). Adverse events were not collected for subjects who did not undergo an implant procedure (24) and consent ineligible subjects (1).
Cardiac disorders Premature ventricular contractions (PVC)	0.24% 2/838 • Number of events 2 • Adverse events are collected from 1st enrollment through study completion (last subject's close-out visit) All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010 The number of participants at risk is defined as the subjects actively enrolled (838). Adverse events were not collected for subjects who did not undergo an implant procedure (24) and consent ineligible subjects (1).
Psychiatric disorders Psychological	0.12% 1/838 • Number of events 1 • Adverse events are collected from 1st enrollment through study completion (last subject's close-out visit) All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010 The number of participants at risk is defined as the subjects actively enrolled (838). Adverse events were not collected for subjects who did not undergo an implant procedure (24) and consent ineligible subjects (1).
Respiratory, thoracic and mediastinal disorders Pulmonary	2.7% 23/838 • Number of events 28 • Adverse events are collected from 1st enrollment through study completion (last subject's close-out visit) All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010 The number of participants at risk is defined as the subjects actively enrolled (838). Adverse events were not collected for subjects who did not undergo an implant procedure (24) and consent ineligible subjects (1).
Cardiac disorders Pulmonary edema - Heart failure	0.24% 2/838 • Number of events 3 • Adverse events are collected from 1st enrollment through study completion (last subject's close-out visit) All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010 The number of participants at risk is defined as the subjects actively enrolled (838). Adverse events were not collected for subjects who did not undergo an implant procedure (24) and consent ineligible subjects (1).
Cardiac disorders Pulmonary embolism (PE)	0.24% 2/838 • Number of events 2 • Adverse events are collected from 1st enrollment through study completion (last subject's close-out visit) All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010 The number of participants at risk is defined as the subjects actively enrolled (838). Adverse events were not collected for subjects who did not undergo an implant procedure (24) and consent ineligible subjects (1).
Renal and urinary disorders Renal	1.4% 12/838 • Number of events 12 • Adverse events are collected from 1st enrollment through study completion (last subject's close-out visit) All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010 The number of participants at risk is defined as the subjects actively enrolled (838). Adverse events were not collected for subjects who did not undergo an implant procedure (24) and consent ineligible subjects (1).
Cardiac disorders Renal insufficiency - Heart failure	0.12% 1/838 • Number of events 1 • Adverse events are collected from 1st enrollment through study completion (last subject's close-out visit) All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010 The number of participants at risk is defined as the subjects actively enrolled (838). Adverse events were not collected for subjects who did not undergo an implant procedure (24) and consent ineligible subjects (1).
Cardiac disorders Sinus bradycardia	0.12% 1/838 • Number of events 1 • Adverse events are collected from 1st enrollment through study completion (last subject's close-out visit) All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010 The number of participants at risk is defined as the subjects actively enrolled (838). Adverse events were not collected for subjects who did not undergo an implant procedure (24) and consent ineligible subjects (1).
Cardiac disorders Syncope	0.12% 1/838 • Number of events 1 • Adverse events are collected from 1st enrollment through study completion (last subject's close-out visit) All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010 The number of participants at risk is defined as the subjects actively enrolled (838). Adverse events were not collected for subjects who did not undergo an implant procedure (24) and consent ineligible subjects (1).
Infections and infestations Systemic infection	0.36% 3/838 • Number of events 3 • Adverse events are collected from 1st enrollment through study completion (last subject's close-out visit) All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010 The number of participants at risk is defined as the subjects actively enrolled (838). Adverse events were not collected for subjects who did not undergo an implant procedure (24) and consent ineligible subjects (1).
Cardiac disorders Thromboembolic events	0.12% 1/838 • Number of events 1 • Adverse events are collected from 1st enrollment through study completion (last subject's close-out visit) All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010 The number of participants at risk is defined as the subjects actively enrolled (838). Adverse events were not collected for subjects who did not undergo an implant procedure (24) and consent ineligible subjects (1).
Cardiac disorders Transient ischemic attack (TIA)	0.12% 1/838 • Number of events 1 • Adverse events are collected from 1st enrollment through study completion (last subject's close-out visit) All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010 The number of participants at risk is defined as the subjects actively enrolled (838). Adverse events were not collected for subjects who did not undergo an implant procedure (24) and consent ineligible subjects (1).
Product Issues Unable to capture - RA	0.12% 1/838 • Number of events 1 • Adverse events are collected from 1st enrollment through study completion (last subject's close-out visit) All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010 The number of participants at risk is defined as the subjects actively enrolled (838). Adverse events were not collected for subjects who did not undergo an implant procedure (24) and consent ineligible subjects (1).
Surgical and medical procedures Venous occlusion	0.12% 1/838 • Number of events 1 • Adverse events are collected from 1st enrollment through study completion (last subject's close-out visit) All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010 The number of participants at risk is defined as the subjects actively enrolled (838). Adverse events were not collected for subjects who did not undergo an implant procedure (24) and consent ineligible subjects (1).
Cardiac disorders Ventricular fibrillation (VF)	1.2% 10/838 • Number of events 15 • Adverse events are collected from 1st enrollment through study completion (last subject's close-out visit) All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010 The number of participants at risk is defined as the subjects actively enrolled (838). Adverse events were not collected for subjects who did not undergo an implant procedure (24) and consent ineligible subjects (1).
Cardiac disorders Ventricular tachycardia (VT)	2.0% 17/838 • Number of events 27 • Adverse events are collected from 1st enrollment through study completion (last subject's close-out visit) All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010 The number of participants at risk is defined as the subjects actively enrolled (838). Adverse events were not collected for subjects who did not undergo an implant procedure (24) and consent ineligible subjects (1).
Cardiac disorders Weight gain - Heart failure	0.12% 1/838 • Number of events 1 • Adverse events are collected from 1st enrollment through study completion (last subject's close-out visit) All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010 The number of participants at risk is defined as the subjects actively enrolled (838). Adverse events were not collected for subjects who did not undergo an implant procedure (24) and consent ineligible subjects (1).

Other adverse events

Other adverse events
Measure	Heart Failure Patients n=838 participants at risk * Subjects with heart failure who receive stable optimal pharmacologic therapy * Moderate to severe heart failure (NYHA Class III-IV) with ejection fraction (EF) ≤ 35% and QRS duration ≥ 120 ms * Left bundle branch block (LBBB) with QRS duration ≥ 130 ms, EF ≤ 30%, and mild (NYHA Class II) ischemic or non-ischemic heart failure or asymptomatic (NYHA Class I) ischemic heart failure. The study is collecting observational data on regular CRT-D device implants with special focus on the left ventricular ACUITY X4® Lead Family' . Left Ventricular lead implant: ACUITY X4® Lead Family: Implantation of (cardiac re-synchronization therapy with defibrillator) CRT-D devices for heartfailure treatment
General disorders Abnormal laboratory values	0.36% 3/838 • Number of events 3 • Adverse events are collected from 1st enrollment through study completion (last subject's close-out visit) All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010 The number of participants at risk is defined as the subjects actively enrolled (838). Adverse events were not collected for subjects who did not undergo an implant procedure (24) and consent ineligible subjects (1).
General disorders Adverse reaction - General	0.24% 2/838 • Number of events 2 • Adverse events are collected from 1st enrollment through study completion (last subject's close-out visit) All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010 The number of participants at risk is defined as the subjects actively enrolled (838). Adverse events were not collected for subjects who did not undergo an implant procedure (24) and consent ineligible subjects (1).
Respiratory, thoracic and mediastinal disorders Adverse reaction - Respiratory	0.12% 1/838 • Number of events 1 • Adverse events are collected from 1st enrollment through study completion (last subject's close-out visit) All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010 The number of participants at risk is defined as the subjects actively enrolled (838). Adverse events were not collected for subjects who did not undergo an implant procedure (24) and consent ineligible subjects (1).
Cardiac disorders Aortic regurgitation	0.12% 1/838 • Number of events 2 • Adverse events are collected from 1st enrollment through study completion (last subject's close-out visit) All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010 The number of participants at risk is defined as the subjects actively enrolled (838). Adverse events were not collected for subjects who did not undergo an implant procedure (24) and consent ineligible subjects (1).
Cardiac disorders Atrial fibrillation (AF)	3.6% 30/838 • Number of events 33 • Adverse events are collected from 1st enrollment through study completion (last subject's close-out visit) All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010 The number of participants at risk is defined as the subjects actively enrolled (838). Adverse events were not collected for subjects who did not undergo an implant procedure (24) and consent ineligible subjects (1).
Cardiac disorders Atrial flutter	0.24% 2/838 • Number of events 2 • Adverse events are collected from 1st enrollment through study completion (last subject's close-out visit) All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010 The number of participants at risk is defined as the subjects actively enrolled (838). Adverse events were not collected for subjects who did not undergo an implant procedure (24) and consent ineligible subjects (1).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer	0.12% 1/838 • Number of events 1 • Adverse events are collected from 1st enrollment through study completion (last subject's close-out visit) All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010 The number of participants at risk is defined as the subjects actively enrolled (838). Adverse events were not collected for subjects who did not undergo an implant procedure (24) and consent ineligible subjects (1).
Cardiac disorders Chest pain - Heart failure	0.24% 2/838 • Number of events 2 • Adverse events are collected from 1st enrollment through study completion (last subject's close-out visit) All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010 The number of participants at risk is defined as the subjects actively enrolled (838). Adverse events were not collected for subjects who did not undergo an implant procedure (24) and consent ineligible subjects (1).
Cardiac disorders Chest pain - Ischemic	0.24% 2/838 • Number of events 2 • Adverse events are collected from 1st enrollment through study completion (last subject's close-out visit) All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010 The number of participants at risk is defined as the subjects actively enrolled (838). Adverse events were not collected for subjects who did not undergo an implant procedure (24) and consent ineligible subjects (1).
Cardiac disorders Chest pain - Other	0.60% 5/838 • Number of events 5 • Adverse events are collected from 1st enrollment through study completion (last subject's close-out visit) All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010 The number of participants at risk is defined as the subjects actively enrolled (838). Adverse events were not collected for subjects who did not undergo an implant procedure (24) and consent ineligible subjects (1).
Surgical and medical procedures Coronary venous dissection	0.95% 8/838 • Number of events 8 • Adverse events are collected from 1st enrollment through study completion (last subject's close-out visit) All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010 The number of participants at risk is defined as the subjects actively enrolled (838). Adverse events were not collected for subjects who did not undergo an implant procedure (24) and consent ineligible subjects (1).
Product Issues Device Deficiency	3.9% 33/838 • Number of events 41 • Adverse events are collected from 1st enrollment through study completion (last subject's close-out visit) All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010 The number of participants at risk is defined as the subjects actively enrolled (838). Adverse events were not collected for subjects who did not undergo an implant procedure (24) and consent ineligible subjects (1).
Product Issues Dislodgment - Elevated threshold - LV	0.24% 2/838 • Number of events 2 • Adverse events are collected from 1st enrollment through study completion (last subject's close-out visit) All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010 The number of participants at risk is defined as the subjects actively enrolled (838). Adverse events were not collected for subjects who did not undergo an implant procedure (24) and consent ineligible subjects (1).
Product Issues Dislodgment - Elevated threshold -RV	0.12% 1/838 • Number of events 1 • Adverse events are collected from 1st enrollment through study completion (last subject's close-out visit) All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010 The number of participants at risk is defined as the subjects actively enrolled (838). Adverse events were not collected for subjects who did not undergo an implant procedure (24) and consent ineligible subjects (1).
Product Issues Dislodgment - Multiple signs - LV	0.12% 1/838 • Number of events 1 • Adverse events are collected from 1st enrollment through study completion (last subject's close-out visit) All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010 The number of participants at risk is defined as the subjects actively enrolled (838). Adverse events were not collected for subjects who did not undergo an implant procedure (24) and consent ineligible subjects (1).
Product Issues Dislodgment - No reported signs - RV	0.12% 1/838 • Number of events 1 • Adverse events are collected from 1st enrollment through study completion (last subject's close-out visit) All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010 The number of participants at risk is defined as the subjects actively enrolled (838). Adverse events were not collected for subjects who did not undergo an implant procedure (24) and consent ineligible subjects (1).
Product Issues Dislodgment - No reported signs -LV	0.12% 1/838 • Number of events 1 • Adverse events are collected from 1st enrollment through study completion (last subject's close-out visit) All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010 The number of participants at risk is defined as the subjects actively enrolled (838). Adverse events were not collected for subjects who did not undergo an implant procedure (24) and consent ineligible subjects (1).
Product Issues Dislodgment - Unable to capture - LV	0.12% 1/838 • Number of events 1 • Adverse events are collected from 1st enrollment through study completion (last subject's close-out visit) All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010 The number of participants at risk is defined as the subjects actively enrolled (838). Adverse events were not collected for subjects who did not undergo an implant procedure (24) and consent ineligible subjects (1).
Product Issues Dislodgment - Unable to capture - RA	0.12% 1/838 • Number of events 1 • Adverse events are collected from 1st enrollment through study completion (last subject's close-out visit) All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010 The number of participants at risk is defined as the subjects actively enrolled (838). Adverse events were not collected for subjects who did not undergo an implant procedure (24) and consent ineligible subjects (1).
Product Issues Dislodgment - Undersensing - RV	0.12% 1/838 • Number of events 1 • Adverse events are collected from 1st enrollment through study completion (last subject's close-out visit) All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010 The number of participants at risk is defined as the subjects actively enrolled (838). Adverse events were not collected for subjects who did not undergo an implant procedure (24) and consent ineligible subjects (1).
Cardiac disorders Dizziness	0.60% 5/838 • Number of events 5 • Adverse events are collected from 1st enrollment through study completion (last subject's close-out visit) All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010 The number of participants at risk is defined as the subjects actively enrolled (838). Adverse events were not collected for subjects who did not undergo an implant procedure (24) and consent ineligible subjects (1).
Cardiac disorders Dyspnea	0.12% 1/838 • Number of events 1 • Adverse events are collected from 1st enrollment through study completion (last subject's close-out visit) All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010 The number of participants at risk is defined as the subjects actively enrolled (838). Adverse events were not collected for subjects who did not undergo an implant procedure (24) and consent ineligible subjects (1).
Cardiac disorders Dyspnea - Heart failure	1.3% 11/838 • Number of events 13 • Adverse events are collected from 1st enrollment through study completion (last subject's close-out visit) All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010 The number of participants at risk is defined as the subjects actively enrolled (838). Adverse events were not collected for subjects who did not undergo an implant procedure (24) and consent ineligible subjects (1).
Product Issues Elevated threshold - LV	1.6% 13/838 • Number of events 14 • Adverse events are collected from 1st enrollment through study completion (last subject's close-out visit) All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010 The number of participants at risk is defined as the subjects actively enrolled (838). Adverse events were not collected for subjects who did not undergo an implant procedure (24) and consent ineligible subjects (1).
Product Issues Elevated threshold - RA	0.48% 4/838 • Number of events 5 • Adverse events are collected from 1st enrollment through study completion (last subject's close-out visit) All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010 The number of participants at risk is defined as the subjects actively enrolled (838). Adverse events were not collected for subjects who did not undergo an implant procedure (24) and consent ineligible subjects (1).
Product Issues Elevated threshold - RV	0.48% 4/838 • Number of events 4 • Adverse events are collected from 1st enrollment through study completion (last subject's close-out visit) All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010 The number of participants at risk is defined as the subjects actively enrolled (838). Adverse events were not collected for subjects who did not undergo an implant procedure (24) and consent ineligible subjects (1).
Endocrine disorders Endocrine	0.60% 5/838 • Number of events 5 • Adverse events are collected from 1st enrollment through study completion (last subject's close-out visit) All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010 The number of participants at risk is defined as the subjects actively enrolled (838). Adverse events were not collected for subjects who did not undergo an implant procedure (24) and consent ineligible subjects (1).
Product Issues Extracardiac stimulation - LV	5.6% 47/838 • Number of events 55 • Adverse events are collected from 1st enrollment through study completion (last subject's close-out visit) All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010 The number of participants at risk is defined as the subjects actively enrolled (838). Adverse events were not collected for subjects who did not undergo an implant procedure (24) and consent ineligible subjects (1).
Product Issues Extracardiac stimulation - RV	0.24% 2/838 • Number of events 3 • Adverse events are collected from 1st enrollment through study completion (last subject's close-out visit) All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010 The number of participants at risk is defined as the subjects actively enrolled (838). Adverse events were not collected for subjects who did not undergo an implant procedure (24) and consent ineligible subjects (1).
Infections and infestations Fever	0.24% 2/838 • Number of events 2 • Adverse events are collected from 1st enrollment through study completion (last subject's close-out visit) All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010 The number of participants at risk is defined as the subjects actively enrolled (838). Adverse events were not collected for subjects who did not undergo an implant procedure (24) and consent ineligible subjects (1).
Gastrointestinal disorders Gastrointestinal	0.95% 8/838 • Number of events 8 • Adverse events are collected from 1st enrollment through study completion (last subject's close-out visit) All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010 The number of participants at risk is defined as the subjects actively enrolled (838). Adverse events were not collected for subjects who did not undergo an implant procedure (24) and consent ineligible subjects (1).
Reproductive system and breast disorders Genitourinary	0.60% 5/838 • Number of events 5 • Adverse events are collected from 1st enrollment through study completion (last subject's close-out visit) All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010 The number of participants at risk is defined as the subjects actively enrolled (838). Adverse events were not collected for subjects who did not undergo an implant procedure (24) and consent ineligible subjects (1).
General disorders Head, eyes, ears, nose, throat (HEENT)	1.2% 10/838 • Number of events 11 • Adverse events are collected from 1st enrollment through study completion (last subject's close-out visit) All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010 The number of participants at risk is defined as the subjects actively enrolled (838). Adverse events were not collected for subjects who did not undergo an implant procedure (24) and consent ineligible subjects (1).
Cardiac disorders Heart failure symptoms - Unspecified	0.24% 2/838 • Number of events 4 • Adverse events are collected from 1st enrollment through study completion (last subject's close-out visit) All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010 The number of participants at risk is defined as the subjects actively enrolled (838). Adverse events were not collected for subjects who did not undergo an implant procedure (24) and consent ineligible subjects (1).
Blood and lymphatic system disorders Hematological	0.24% 2/838 • Number of events 2 • Adverse events are collected from 1st enrollment through study completion (last subject's close-out visit) All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010 The number of participants at risk is defined as the subjects actively enrolled (838). Adverse events were not collected for subjects who did not undergo an implant procedure (24) and consent ineligible subjects (1).
Surgical and medical procedures Hematoma - Pocket (<= 30 days post-implant)	1.6% 13/838 • Number of events 13 • Adverse events are collected from 1st enrollment through study completion (last subject's close-out visit) All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010 The number of participants at risk is defined as the subjects actively enrolled (838). Adverse events were not collected for subjects who did not undergo an implant procedure (24) and consent ineligible subjects (1).
Surgical and medical procedures Hematoma - Pocket (> 30 days post-implant)	0.12% 1/838 • Number of events 1 • Adverse events are collected from 1st enrollment through study completion (last subject's close-out visit) All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010 The number of participants at risk is defined as the subjects actively enrolled (838). Adverse events were not collected for subjects who did not undergo an implant procedure (24) and consent ineligible subjects (1).
Cardiac disorders Hematoma - Unrelated to procedure or device	0.12% 1/838 • Number of events 1 • Adverse events are collected from 1st enrollment through study completion (last subject's close-out visit) All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010 The number of participants at risk is defined as the subjects actively enrolled (838). Adverse events were not collected for subjects who did not undergo an implant procedure (24) and consent ineligible subjects (1).
Cardiac disorders Hypertension - Heart failure	0.12% 1/838 • Number of events 1 • Adverse events are collected from 1st enrollment through study completion (last subject's close-out visit) All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010 The number of participants at risk is defined as the subjects actively enrolled (838). Adverse events were not collected for subjects who did not undergo an implant procedure (24) and consent ineligible subjects (1).
Cardiac disorders Hypotension	0.36% 3/838 • Number of events 3 • Adverse events are collected from 1st enrollment through study completion (last subject's close-out visit) All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010 The number of participants at risk is defined as the subjects actively enrolled (838). Adverse events were not collected for subjects who did not undergo an implant procedure (24) and consent ineligible subjects (1).
Cardiac disorders Hypotension - Heart failure	0.12% 1/838 • Number of events 1 • Adverse events are collected from 1st enrollment through study completion (last subject's close-out visit) All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010 The number of participants at risk is defined as the subjects actively enrolled (838). Adverse events were not collected for subjects who did not undergo an implant procedure (24) and consent ineligible subjects (1).
Product Issues Impedance > 2000 ohms - LV	0.12% 1/838 • Number of events 1 • Adverse events are collected from 1st enrollment through study completion (last subject's close-out visit) All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010 The number of participants at risk is defined as the subjects actively enrolled (838). Adverse events were not collected for subjects who did not undergo an implant procedure (24) and consent ineligible subjects (1).
Product Issues Impedance > 2000 ohms - RA	0.12% 1/838 • Number of events 1 • Adverse events are collected from 1st enrollment through study completion (last subject's close-out visit) All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010 The number of participants at risk is defined as the subjects actively enrolled (838). Adverse events were not collected for subjects who did not undergo an implant procedure (24) and consent ineligible subjects (1).
Product Issues Impedance > 2000 ohms - RV	0.12% 1/838 • Number of events 1 • Adverse events are collected from 1st enrollment through study completion (last subject's close-out visit) All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010 The number of participants at risk is defined as the subjects actively enrolled (838). Adverse events were not collected for subjects who did not undergo an implant procedure (24) and consent ineligible subjects (1).
Product Issues Inappropriate AV delay	0.12% 1/838 • Number of events 1 • Adverse events are collected from 1st enrollment through study completion (last subject's close-out visit) All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010 The number of participants at risk is defined as the subjects actively enrolled (838). Adverse events were not collected for subjects who did not undergo an implant procedure (24) and consent ineligible subjects (1).
Product Issues Inappropriate tachy therapy - Other	0.12% 1/838 • Number of events 1 • Adverse events are collected from 1st enrollment through study completion (last subject's close-out visit) All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010 The number of participants at risk is defined as the subjects actively enrolled (838). Adverse events were not collected for subjects who did not undergo an implant procedure (24) and consent ineligible subjects (1).
Product Issues Inappropriate tachy therapy - SVT	0.60% 5/838 • Number of events 5 • Adverse events are collected from 1st enrollment through study completion (last subject's close-out visit) All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010 The number of participants at risk is defined as the subjects actively enrolled (838). Adverse events were not collected for subjects who did not undergo an implant procedure (24) and consent ineligible subjects (1).
Product Issues Infection (> 30 days post-implant)	0.24% 2/838 • Number of events 2 • Adverse events are collected from 1st enrollment through study completion (last subject's close-out visit) All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010 The number of participants at risk is defined as the subjects actively enrolled (838). Adverse events were not collected for subjects who did not undergo an implant procedure (24) and consent ineligible subjects (1).
Skin and subcutaneous tissue disorders Integumentary	0.48% 4/838 • Number of events 4 • Adverse events are collected from 1st enrollment through study completion (last subject's close-out visit) All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010 The number of participants at risk is defined as the subjects actively enrolled (838). Adverse events were not collected for subjects who did not undergo an implant procedure (24) and consent ineligible subjects (1).
Cardiac disorders Multiple heart failure symptoms	0.24% 2/838 • Number of events 2 • Adverse events are collected from 1st enrollment through study completion (last subject's close-out visit) All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010 The number of participants at risk is defined as the subjects actively enrolled (838). Adverse events were not collected for subjects who did not undergo an implant procedure (24) and consent ineligible subjects (1).
Cardiac disorders Multiple symptoms	0.12% 1/838 • Number of events 1 • Adverse events are collected from 1st enrollment through study completion (last subject's close-out visit) All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010 The number of participants at risk is defined as the subjects actively enrolled (838). Adverse events were not collected for subjects who did not undergo an implant procedure (24) and consent ineligible subjects (1).
Musculoskeletal and connective tissue disorders Musculoskeletal	1.2% 10/838 • Number of events 12 • Adverse events are collected from 1st enrollment through study completion (last subject's close-out visit) All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010 The number of participants at risk is defined as the subjects actively enrolled (838). Adverse events were not collected for subjects who did not undergo an implant procedure (24) and consent ineligible subjects (1).
Nervous system disorders Neurological	0.24% 2/838 • Number of events 2 • Adverse events are collected from 1st enrollment through study completion (last subject's close-out visit) All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010 The number of participants at risk is defined as the subjects actively enrolled (838). Adverse events were not collected for subjects who did not undergo an implant procedure (24) and consent ineligible subjects (1).
Cardiac disorders Nonsustained ventricular tachycardia (NSVT)	0.36% 3/838 • Number of events 3 • Adverse events are collected from 1st enrollment through study completion (last subject's close-out visit) All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010 The number of participants at risk is defined as the subjects actively enrolled (838). Adverse events were not collected for subjects who did not undergo an implant procedure (24) and consent ineligible subjects (1).
Product Issues Other - Lead	0.48% 4/838 • Number of events 4 • Adverse events are collected from 1st enrollment through study completion (last subject's close-out visit) All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010 The number of participants at risk is defined as the subjects actively enrolled (838). Adverse events were not collected for subjects who did not undergo an implant procedure (24) and consent ineligible subjects (1).
Surgical and medical procedures Other - Lead - Procedure	10.4% 87/838 • Number of events 92 • Adverse events are collected from 1st enrollment through study completion (last subject's close-out visit) All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010 The number of participants at risk is defined as the subjects actively enrolled (838). Adverse events were not collected for subjects who did not undergo an implant procedure (24) and consent ineligible subjects (1).
Product Issues Other - PG system	0.12% 1/838 • Number of events 1 • Adverse events are collected from 1st enrollment through study completion (last subject's close-out visit) All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010 The number of participants at risk is defined as the subjects actively enrolled (838). Adverse events were not collected for subjects who did not undergo an implant procedure (24) and consent ineligible subjects (1).
Surgical and medical procedures Other - PG system - Procedure	1.2% 10/838 • Number of events 10 • Adverse events are collected from 1st enrollment through study completion (last subject's close-out visit) All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010 The number of participants at risk is defined as the subjects actively enrolled (838). Adverse events were not collected for subjects who did not undergo an implant procedure (24) and consent ineligible subjects (1).
Cardiac disorders Other- Heart failure patient condition - Cardiovascular	0.12% 1/838 • Number of events 1 • Adverse events are collected from 1st enrollment through study completion (last subject's close-out visit) All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010 The number of participants at risk is defined as the subjects actively enrolled (838). Adverse events were not collected for subjects who did not undergo an implant procedure (24) and consent ineligible subjects (1).
General disorders Other- Patient condition - Non- cardiovascular	0.12% 1/838 • Number of events 1 • Adverse events are collected from 1st enrollment through study completion (last subject's close-out visit) All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010 The number of participants at risk is defined as the subjects actively enrolled (838). Adverse events were not collected for subjects who did not undergo an implant procedure (24) and consent ineligible subjects (1).
Cardiac disorders Other SVT (eg AVRT, AVNRT, EAT)	0.36% 3/838 • Number of events 3 • Adverse events are collected from 1st enrollment through study completion (last subject's close-out visit) All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010 The number of participants at risk is defined as the subjects actively enrolled (838). Adverse events were not collected for subjects who did not undergo an implant procedure (24) and consent ineligible subjects (1).
Product Issues Oversensing - RV	0.12% 1/838 • Number of events 1 • Adverse events are collected from 1st enrollment through study completion (last subject's close-out visit) All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010 The number of participants at risk is defined as the subjects actively enrolled (838). Adverse events were not collected for subjects who did not undergo an implant procedure (24) and consent ineligible subjects (1).
Product Issues Pacemaker-mediated tachycardia (PMT)	0.12% 1/838 • Number of events 1 • Adverse events are collected from 1st enrollment through study completion (last subject's close-out visit) All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010 The number of participants at risk is defined as the subjects actively enrolled (838). Adverse events were not collected for subjects who did not undergo an implant procedure (24) and consent ineligible subjects (1).
Cardiac disorders Palpitations	0.12% 1/838 • Number of events 1 • Adverse events are collected from 1st enrollment through study completion (last subject's close-out visit) All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010 The number of participants at risk is defined as the subjects actively enrolled (838). Adverse events were not collected for subjects who did not undergo an implant procedure (24) and consent ineligible subjects (1).
Cardiac disorders Pericarditis - Unrelated to procedure or device	0.12% 1/838 • Number of events 1 • Adverse events are collected from 1st enrollment through study completion (last subject's close-out visit) All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010 The number of participants at risk is defined as the subjects actively enrolled (838). Adverse events were not collected for subjects who did not undergo an implant procedure (24) and consent ineligible subjects (1).
Cardiac disorders Peripheral edema - Heart failure	0.36% 3/838 • Number of events 3 • Adverse events are collected from 1st enrollment through study completion (last subject's close-out visit) All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010 The number of participants at risk is defined as the subjects actively enrolled (838). Adverse events were not collected for subjects who did not undergo an implant procedure (24) and consent ineligible subjects (1).
General disorders Physical trauma	0.12% 1/838 • Number of events 1 • Adverse events are collected from 1st enrollment through study completion (last subject's close-out visit) All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010 The number of participants at risk is defined as the subjects actively enrolled (838). Adverse events were not collected for subjects who did not undergo an implant procedure (24) and consent ineligible subjects (1).
Surgical and medical procedures Pleural effusion - Procedure	0.12% 1/838 • Number of events 1 • Adverse events are collected from 1st enrollment through study completion (last subject's close-out visit) All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010 The number of participants at risk is defined as the subjects actively enrolled (838). Adverse events were not collected for subjects who did not undergo an implant procedure (24) and consent ineligible subjects (1).
Surgical and medical procedures Pneumothorax - Procedure	0.24% 2/838 • Number of events 2 • Adverse events are collected from 1st enrollment through study completion (last subject's close-out visit) All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010 The number of participants at risk is defined as the subjects actively enrolled (838). Adverse events were not collected for subjects who did not undergo an implant procedure (24) and consent ineligible subjects (1).
Surgical and medical procedures Post-surgical wound discomfort	0.72% 6/838 • Number of events 6 • Adverse events are collected from 1st enrollment through study completion (last subject's close-out visit) All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010 The number of participants at risk is defined as the subjects actively enrolled (838). Adverse events were not collected for subjects who did not undergo an implant procedure (24) and consent ineligible subjects (1).
Cardiac disorders Premature ventricular contractions (PVC)	1.7% 14/838 • Number of events 16 • Adverse events are collected from 1st enrollment through study completion (last subject's close-out visit) All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010 The number of participants at risk is defined as the subjects actively enrolled (838). Adverse events were not collected for subjects who did not undergo an implant procedure (24) and consent ineligible subjects (1).
Psychiatric disorders Psychological	0.24% 2/838 • Number of events 4 • Adverse events are collected from 1st enrollment through study completion (last subject's close-out visit) All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010 The number of participants at risk is defined as the subjects actively enrolled (838). Adverse events were not collected for subjects who did not undergo an implant procedure (24) and consent ineligible subjects (1).
Respiratory, thoracic and mediastinal disorders Pulmonary	0.95% 8/838 • Number of events 8 • Adverse events are collected from 1st enrollment through study completion (last subject's close-out visit) All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010 The number of participants at risk is defined as the subjects actively enrolled (838). Adverse events were not collected for subjects who did not undergo an implant procedure (24) and consent ineligible subjects (1).
Product Issues Rate response inappropriate	0.12% 1/838 • Number of events 1 • Adverse events are collected from 1st enrollment through study completion (last subject's close-out visit) All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010 The number of participants at risk is defined as the subjects actively enrolled (838). Adverse events were not collected for subjects who did not undergo an implant procedure (24) and consent ineligible subjects (1).
Renal and urinary disorders Renal	0.24% 2/838 • Number of events 2 • Adverse events are collected from 1st enrollment through study completion (last subject's close-out visit) All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010 The number of participants at risk is defined as the subjects actively enrolled (838). Adverse events were not collected for subjects who did not undergo an implant procedure (24) and consent ineligible subjects (1).
Product Issues RVAT Communication	0.72% 6/838 • Number of events 6 • Adverse events are collected from 1st enrollment through study completion (last subject's close-out visit) All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010 The number of participants at risk is defined as the subjects actively enrolled (838). Adverse events were not collected for subjects who did not undergo an implant procedure (24) and consent ineligible subjects (1).
Cardiac disorders Sinus bradycardia	0.12% 1/838 • Number of events 1 • Adverse events are collected from 1st enrollment through study completion (last subject's close-out visit) All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010 The number of participants at risk is defined as the subjects actively enrolled (838). Adverse events were not collected for subjects who did not undergo an implant procedure (24) and consent ineligible subjects (1).
Cardiac disorders Sinus tachycardia	0.12% 1/838 • Number of events 1 • Adverse events are collected from 1st enrollment through study completion (last subject's close-out visit) All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010 The number of participants at risk is defined as the subjects actively enrolled (838). Adverse events were not collected for subjects who did not undergo an implant procedure (24) and consent ineligible subjects (1).
Cardiac disorders Syncope	0.12% 1/838 • Number of events 1 • Adverse events are collected from 1st enrollment through study completion (last subject's close-out visit) All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010 The number of participants at risk is defined as the subjects actively enrolled (838). Adverse events were not collected for subjects who did not undergo an implant procedure (24) and consent ineligible subjects (1).
Cardiac disorders Thromboembolic events	0.12% 1/838 • Number of events 1 • Adverse events are collected from 1st enrollment through study completion (last subject's close-out visit) All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010 The number of participants at risk is defined as the subjects actively enrolled (838). Adverse events were not collected for subjects who did not undergo an implant procedure (24) and consent ineligible subjects (1).
Cardiac disorders Transient ischemic attack (TIA)	0.12% 1/838 • Number of events 1 • Adverse events are collected from 1st enrollment through study completion (last subject's close-out visit) All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010 The number of participants at risk is defined as the subjects actively enrolled (838). Adverse events were not collected for subjects who did not undergo an implant procedure (24) and consent ineligible subjects (1).
Product Issues Unable to capture - LV	0.12% 1/838 • Number of events 1 • Adverse events are collected from 1st enrollment through study completion (last subject's close-out visit) All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010 The number of participants at risk is defined as the subjects actively enrolled (838). Adverse events were not collected for subjects who did not undergo an implant procedure (24) and consent ineligible subjects (1).
Cardiac disorders Vasovagal reaction	0.12% 1/838 • Number of events 1 • Adverse events are collected from 1st enrollment through study completion (last subject's close-out visit) All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010 The number of participants at risk is defined as the subjects actively enrolled (838). Adverse events were not collected for subjects who did not undergo an implant procedure (24) and consent ineligible subjects (1).
Surgical and medical procedures Venous occlusion	0.12% 1/838 • Number of events 1 • Adverse events are collected from 1st enrollment through study completion (last subject's close-out visit) All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010 The number of participants at risk is defined as the subjects actively enrolled (838). Adverse events were not collected for subjects who did not undergo an implant procedure (24) and consent ineligible subjects (1).
Cardiac disorders Ventricular fibrillation (VF)	0.48% 4/838 • Number of events 4 • Adverse events are collected from 1st enrollment through study completion (last subject's close-out visit) All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010 The number of participants at risk is defined as the subjects actively enrolled (838). Adverse events were not collected for subjects who did not undergo an implant procedure (24) and consent ineligible subjects (1).
Cardiac disorders Ventricular tachycardia (VT)	1.1% 9/838 • Number of events 14 • Adverse events are collected from 1st enrollment through study completion (last subject's close-out visit) All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010 The number of participants at risk is defined as the subjects actively enrolled (838). Adverse events were not collected for subjects who did not undergo an implant procedure (24) and consent ineligible subjects (1).

Additional Information

Caroline Beaudoint

Boston Scientific

Phone: +32479904163

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 30 days from the time submitted to the sponsor for review. The sponsor can request changes to the communication.
Publication restrictions are in place

Restriction type: OTHER