Trial Outcomes & Findings for Heart Failure and Sudden Cardiac Death Japan Registry (NCT NCT03185832)

NCT ID: NCT03185832

Last Updated: 2022-02-14

Results Overview

Number of Participants with first appropriately treated ventricular arrhythmia (by anti tachycardia pacing \[ATP\] or shock) or life-threatening symptoms associated to ventricular arrhythmia (defined as hemodynamic instability which requires treatment), whichever comes first under MADIT Arm B or C programming conditions in a study population with a majority of Japanese subjects.

Recruitment status

COMPLETED

Target enrollment

354 participants

Primary outcome timeframe

12 months follow up

Results posted on

2022-02-14

Participant Flow

The first subject was enrolled on 21 July 2017 and the last subject follow-up occurred on 14 September 2020. Study completion date, defined as the date the final participant was examined or received an intervention for purposes of final collection of data for the primary and secondary outcome measures and adverse events, is 1 December 2020. A total of 354 subjects across 34 centers in Japan were enrolled and assigned to a study cohort.

Out of 357 enrolled patients, 3 did not meet eligibility criteria and were considered consent ineligible.

Participant milestones

Participant milestones
Measure	CRT-D Cohort This subject cohort is made by all patients enrolled and implanted with cardiac resynchronization therapy defibrillator (CRT-D)	ICD Cohort This subject cohort is made by all patients enrolled and implanted with implantable cardioverter-defibrillator (ICD)	Pacing Cohort This subject cohort is made by all patients enrolled and implanted with pacemakers (PM) with or without cardiac resynchronization therapy (CRT) capabilities	Non-device Cohort Patient enrolled but not implanted with a Defibrillator or Pacemaker
Overall Study STARTED	69	102	68	115
Overall Study COMPLETED	60	87	58	104
Overall Study NOT COMPLETED	9	15	10	11

Reasons for withdrawal

Reasons for withdrawal
Measure	CRT-D Cohort This subject cohort is made by all patients enrolled and implanted with cardiac resynchronization therapy defibrillator (CRT-D)	ICD Cohort This subject cohort is made by all patients enrolled and implanted with implantable cardioverter-defibrillator (ICD)	Pacing Cohort This subject cohort is made by all patients enrolled and implanted with pacemakers (PM) with or without cardiac resynchronization therapy (CRT) capabilities	Non-device Cohort Patient enrolled but not implanted with a Defibrillator or Pacemaker
Overall Study Death	9	14	9	7
Overall Study Withdrawn - vital status available	0	1	1	4

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CRT-D Cohort n=69 Participants This subject cohort is made by all patients enrolled and implanted with defibrillator with CRT capabilities	ICD Cohort n=102 Participants This subject cohort is made by all patients enrolled and implanted with defibrillator capabilities	Pacing Cohort n=68 Participants This subject cohort is made by all patients enrolled and implanted with pacemakers with or without CRT capabilities	Non-device Cohort n=115 Participants Patient enrolled but not implanted with a Defibrillator or Pacemaker	Total n=354 Participants Total of all reporting groups
Age, Continuous	66.4 years STANDARD_DEVIATION 13.4 • n=69 Participants	68.2 years STANDARD_DEVIATION 10.4 • n=102 Participants	75.0 years STANDARD_DEVIATION 10.9 • n=68 Participants	68.8 years STANDARD_DEVIATION 11.8 • n=115 Participants	69.4 years STANDARD_DEVIATION 11.9 • n=354 Participants
Sex: Female, Male Female	22 Participants n=69 Participants	15 Participants n=102 Participants	24 Participants n=68 Participants	25 Participants n=115 Participants	86 Participants n=354 Participants
Sex: Female, Male Male	47 Participants n=69 Participants	87 Participants n=102 Participants	44 Participants n=68 Participants	90 Participants n=115 Participants	268 Participants n=354 Participants
Race and Ethnicity Not Collected	—	—	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Japan	69 participants n=69 Participants	102 participants n=102 Participants	68 participants n=68 Participants	115 participants n=115 Participants	354 participants n=354 Participants

PRIMARY outcome

Timeframe: 12 months follow up

Population: ICD Cohort: subjects with criteria for sudden cardiac death (SCD) (without spontaneous prior ventricular sustained arrhythmia) and de novo implanted Defibrillator device treatment (ICD). CRT-D Cohort: subjects with criteria for SCD and widely accepted standard CRT indication who received a de novo implanted CRT D device treatment.

Number of Participants with first appropriately treated ventricular arrhythmia (by anti tachycardia pacing \[ATP\] or shock) or life-threatening symptoms associated to ventricular arrhythmia (defined as hemodynamic instability which requires treatment), whichever comes first under MADIT Arm B or C programming conditions in a study population with a majority of Japanese subjects.

Outcome measures

Outcome measures
Measure	CRT-D Cohort n=69 Participants This subject cohort is made by all patients enrolled and implanted with defibrillator with CRT capabilities	ICD Cohort n=102 Participants This subject cohort is made by all patients enrolled and implanted with defibrillator capabilities	Pacing Cohort This subject cohort is made by all patients enrolled and implanted with pacemakers with or without CRT capabilities
Number of Participants With Ventricular Arrhythmia Associated Symptoms - ICD/CRT-D Cohorts	3 Participants	8 Participants	—

PRIMARY outcome

Timeframe: 12 months follow up

Population: Subjects who were clinically expected to require \>40% right ventricular pacing with a left ventricular ejection fraction (LVEF) ≤50%, any determined New York Heart Association (NYHA) Class, and receiving PM or CRT-Pacemaker (CRT-P) therapy despite previous device history (de novo, box changes, system revisions or upgrades).

All-cause mortality in subjects with a maximum of 3 risk factors (analyzed for MADIT II data).

Outcome measures

Outcome measures
Measure	CRT-D Cohort n=39 Participants This subject cohort is made by all patients enrolled and implanted with defibrillator with CRT capabilities	ICD Cohort This subject cohort is made by all patients enrolled and implanted with defibrillator capabilities	Pacing Cohort This subject cohort is made by all patients enrolled and implanted with pacemakers with or without CRT capabilities
Number of Participant Deaths - Pacing Cohort	3 Participants	—	—

PRIMARY outcome

Timeframe: 12 months follow up

Population: Subjects with criteria for SCD fulfilling European Society of Cardiology (ESC) ICD or CRT-D therapy guidelines (2016) with an LVEF ≤35%, having 2 to 5 predefined risk factors but do not have or have had a cardiac implanted device ICD, CRT-D, PM, or CRT-P.

All-cause mortality in the subject cohort with 2 to 5 predefined SCD driving risk factors.

Outcome measures

Outcome measures
Measure	CRT-D Cohort n=115 Participants This subject cohort is made by all patients enrolled and implanted with defibrillator with CRT capabilities	ICD Cohort This subject cohort is made by all patients enrolled and implanted with defibrillator capabilities	Pacing Cohort This subject cohort is made by all patients enrolled and implanted with pacemakers with or without CRT capabilities
Number of Participant Deaths - Non-Device Cohort	5 Participants	—	—

SECONDARY outcome

Timeframe: 12 months follow up

Population: ICD Cohort: subjects with criteria for SCD (without spontaneous prior ventricular sustained arrhythmia) and de novo implanted Defibrillator device treatment (ICD). CRT-D Cohort: subject with criteria for SCD and widely accepted standard CRT indication who received a de novo implanted CRT D device treatment.

All-cause mortality for the ICD and the CRT-D cohorts.

Outcome measures

Outcome measures
Measure	CRT-D Cohort n=69 Participants This subject cohort is made by all patients enrolled and implanted with defibrillator with CRT capabilities	ICD Cohort n=102 Participants This subject cohort is made by all patients enrolled and implanted with defibrillator capabilities	Pacing Cohort This subject cohort is made by all patients enrolled and implanted with pacemakers with or without CRT capabilities
Number of Participant Deaths - ICD/CRT-D Cohorts	5 Participants	3 Participants	—

SECONDARY outcome

Timeframe: 12 months follow up

Population: ICD Cohort: subjects with criteria for SCD (without spontaneous prior ventricular sustained arrhythmia) and de novo ICD implant. CRT-D Cohort: subject with criteria for SCD and widely accepted standard CRT indication who received a de novo CRT-D implant. PM/CRT-P Cohort: subjects who were clinically expected to require \>40% right ventricular pacing with an LVEF ≤50%, any determined New York Heart Association (NYHA) Class, and receiving PM or CRT-P therapy despite previous device history.

Number of Participants with HF events, which require intravenous (IV) treatment and/or heart failure (HF) related hospitalization, or which led to HF death

Outcome measures

Outcome measures
Measure	CRT-D Cohort n=69 Participants This subject cohort is made by all patients enrolled and implanted with defibrillator with CRT capabilities	ICD Cohort n=102 Participants This subject cohort is made by all patients enrolled and implanted with defibrillator capabilities	Pacing Cohort n=68 Participants This subject cohort is made by all patients enrolled and implanted with pacemakers with or without CRT capabilities
Number of Participants With Composite HF Event - ICD/CRT-D/Pacing Cohorts	16 Participants	27 Participants	9 Participants

SECONDARY outcome

Timeframe: 12 months follow up

Population: ICD Cohort: subjects with criteria for SCD (without spontaneous prior ventricular sustained arrhythmia) and de novo ICD implant. CRT-D Cohort: subject with criteria for SCD and widely accepted standard CRT indication who received a de novo CRT-D implant. PM/CRT-P Cohort: subjects who were clinically expected to require \>40% right ventricular pacing with an LVEF ≤50%, any determined New York Heart Association (NYHA) Class, and receiving PM or CRT-P therapy despite previous device history.

Complication refers to qualified serious adverse device effects (SADEs) post success implantation, such as re-implant procedure, required invasive procedure related to the device system, pacing exit block, all-cause infection, and death due to therapy failure.

Outcome measures

Outcome measures
Measure	CRT-D Cohort n=69 Participants This subject cohort is made by all patients enrolled and implanted with defibrillator with CRT capabilities	ICD Cohort n=102 Participants This subject cohort is made by all patients enrolled and implanted with defibrillator capabilities	Pacing Cohort n=68 Participants This subject cohort is made by all patients enrolled and implanted with pacemakers with or without CRT capabilities
Number of Participants With Complication - ICD/CRT-D/Pacing Cohorts	3 Participants	4 Participants	2 Participants

Adverse Events

Actively Enrolled Patients

Serious events: 172 serious events

Other events: 99 other events

Deaths: 39 deaths

Serious adverse events

Serious adverse events
Measure	Actively Enrolled Patients n=354 participants at risk Patients actively enrolled in the study, defined as subjects who met all eligibility criteria and who signed informed consent
Product Issues Infection (> 30 days post implant)	0.84% 2/239 • Number of events 2 • Adverse events are collected through study completion, an average of 20 months All adverse events are collected as per ISO 14155 and medical device guidance (MEDDEV) 2.7/4. As per protocol, adverse events were collected irrespective of cohort allocation and therefore are not reported separately
Surgical and medical procedures Hematoma- Pocket (>30 days post implant)	0.42% 1/239 • Number of events 1 • Adverse events are collected through study completion, an average of 20 months All adverse events are collected as per ISO 14155 and medical device guidance (MEDDEV) 2.7/4. As per protocol, adverse events were collected irrespective of cohort allocation and therefore are not reported separately
Product Issues Elevated Threshold - RV Lead	1.2% 2/171 • Number of events 2 • Adverse events are collected through study completion, an average of 20 months All adverse events are collected as per ISO 14155 and medical device guidance (MEDDEV) 2.7/4. As per protocol, adverse events were collected irrespective of cohort allocation and therefore are not reported separately
Product Issues Elevated Threshold - LV Lead	0.87% 1/115 • Number of events 1 • Adverse events are collected through study completion, an average of 20 months All adverse events are collected as per ISO 14155 and medical device guidance (MEDDEV) 2.7/4. As per protocol, adverse events were collected irrespective of cohort allocation and therefore are not reported separately
Surgical and medical procedures Post-surgical pocket hemorrhage/bleeding/drainage	0.84% 2/239 • Number of events 2 • Adverse events are collected through study completion, an average of 20 months All adverse events are collected as per ISO 14155 and medical device guidance (MEDDEV) 2.7/4. As per protocol, adverse events were collected irrespective of cohort allocation and therefore are not reported separately
Surgical and medical procedures Post -Surgical infection (<= 30 days post implant)	0.42% 1/239 • Number of events 1 • Adverse events are collected through study completion, an average of 20 months All adverse events are collected as per ISO 14155 and medical device guidance (MEDDEV) 2.7/4. As per protocol, adverse events were collected irrespective of cohort allocation and therefore are not reported separately
Surgical and medical procedures Hematoma - pocket (<= 30 days post-implant)	0.84% 2/239 • Number of events 2 • Adverse events are collected through study completion, an average of 20 months All adverse events are collected as per ISO 14155 and medical device guidance (MEDDEV) 2.7/4. As per protocol, adverse events were collected irrespective of cohort allocation and therefore are not reported separately
Cardiac disorders Syncope - Heart Failure	0.28% 1/354 • Number of events 1 • Adverse events are collected through study completion, an average of 20 months All adverse events are collected as per ISO 14155 and medical device guidance (MEDDEV) 2.7/4. As per protocol, adverse events were collected irrespective of cohort allocation and therefore are not reported separately
Cardiac disorders Dizziness - Heart Failure	0.28% 1/354 • Number of events 1 • Adverse events are collected through study completion, an average of 20 months All adverse events are collected as per ISO 14155 and medical device guidance (MEDDEV) 2.7/4. As per protocol, adverse events were collected irrespective of cohort allocation and therefore are not reported separately
Cardiac disorders Chest Pain - Heart Failure	0.28% 1/354 • Number of events 1 • Adverse events are collected through study completion, an average of 20 months All adverse events are collected as per ISO 14155 and medical device guidance (MEDDEV) 2.7/4. As per protocol, adverse events were collected irrespective of cohort allocation and therefore are not reported separately
Cardiac disorders Dyspnea - Heart Failure	10.7% 38/354 • Number of events 46 • Adverse events are collected through study completion, an average of 20 months All adverse events are collected as per ISO 14155 and medical device guidance (MEDDEV) 2.7/4. As per protocol, adverse events were collected irrespective of cohort allocation and therefore are not reported separately
Cardiac disorders Peripheral edema - Heart Failure	0.56% 2/354 • Number of events 8 • Adverse events are collected through study completion, an average of 20 months All adverse events are collected as per ISO 14155 and medical device guidance (MEDDEV) 2.7/4. As per protocol, adverse events were collected irrespective of cohort allocation and therefore are not reported separately
Cardiac disorders Fatigue - Heart Failure	1.4% 5/354 • Number of events 5 • Adverse events are collected through study completion, an average of 20 months All adverse events are collected as per ISO 14155 and medical device guidance (MEDDEV) 2.7/4. As per protocol, adverse events were collected irrespective of cohort allocation and therefore are not reported separately
Renal and urinary disorders Renal Failure/Insufficiency - Heart Failure	0.85% 3/354 • Number of events 3 • Adverse events are collected through study completion, an average of 20 months All adverse events are collected as per ISO 14155 and medical device guidance (MEDDEV) 2.7/4. As per protocol, adverse events were collected irrespective of cohort allocation and therefore are not reported separately
Cardiac disorders Dehydration - Heart Failure	0.28% 1/354 • Number of events 1 • Adverse events are collected through study completion, an average of 20 months All adverse events are collected as per ISO 14155 and medical device guidance (MEDDEV) 2.7/4. As per protocol, adverse events were collected irrespective of cohort allocation and therefore are not reported separately
Cardiac disorders Weight Gain - Heart Failure	1.1% 4/354 • Number of events 4 • Adverse events are collected through study completion, an average of 20 months All adverse events are collected as per ISO 14155 and medical device guidance (MEDDEV) 2.7/4. As per protocol, adverse events were collected irrespective of cohort allocation and therefore are not reported separately
Cardiac disorders Pleural Effusion - Heart Failure	0.28% 1/354 • Number of events 1 • Adverse events are collected through study completion, an average of 20 months All adverse events are collected as per ISO 14155 and medical device guidance (MEDDEV) 2.7/4. As per protocol, adverse events were collected irrespective of cohort allocation and therefore are not reported separately
Cardiac disorders Cardiac Medication Complication - Heart Failure	0.28% 1/354 • Number of events 1 • Adverse events are collected through study completion, an average of 20 months All adverse events are collected as per ISO 14155 and medical device guidance (MEDDEV) 2.7/4. As per protocol, adverse events were collected irrespective of cohort allocation and therefore are not reported separately
Cardiac disorders Heart Failure Symptoms - Unspecified	5.9% 21/354 • Number of events 23 • Adverse events are collected through study completion, an average of 20 months All adverse events are collected as per ISO 14155 and medical device guidance (MEDDEV) 2.7/4. As per protocol, adverse events were collected irrespective of cohort allocation and therefore are not reported separately
Cardiac disorders Multiple Heart Failure Symptoms	7.9% 28/354 • Number of events 35 • Adverse events are collected through study completion, an average of 20 months All adverse events are collected as per ISO 14155 and medical device guidance (MEDDEV) 2.7/4. As per protocol, adverse events were collected irrespective of cohort allocation and therefore are not reported separately
Cardiac disorders Other - Heart failure patient condition	1.1% 4/354 • Number of events 4 • Adverse events are collected through study completion, an average of 20 months All adverse events are collected as per ISO 14155 and medical device guidance (MEDDEV) 2.7/4. As per protocol, adverse events were collected irrespective of cohort allocation and therefore are not reported separately
Cardiac disorders Sinus Bradycardia	0.28% 1/354 • Number of events 1 • Adverse events are collected through study completion, an average of 20 months All adverse events are collected as per ISO 14155 and medical device guidance (MEDDEV) 2.7/4. As per protocol, adverse events were collected irrespective of cohort allocation and therefore are not reported separately
Cardiac disorders Ventricular Fibrillation (VF)	1.7% 6/354 • Number of events 6 • Adverse events are collected through study completion, an average of 20 months All adverse events are collected as per ISO 14155 and medical device guidance (MEDDEV) 2.7/4. As per protocol, adverse events were collected irrespective of cohort allocation and therefore are not reported separately
Cardiac disorders Ventricular Tachycardia (VT)/Monomorphic VT	3.7% 13/354 • Number of events 22 • Adverse events are collected through study completion, an average of 20 months All adverse events are collected as per ISO 14155 and medical device guidance (MEDDEV) 2.7/4. As per protocol, adverse events were collected irrespective of cohort allocation and therefore are not reported separately
Cardiac disorders Nonsustained ventricular tachycardia (NSVT)	0.28% 1/354 • Number of events 1 • Adverse events are collected through study completion, an average of 20 months All adverse events are collected as per ISO 14155 and medical device guidance (MEDDEV) 2.7/4. As per protocol, adverse events were collected irrespective of cohort allocation and therefore are not reported separately
Cardiac disorders Atrial Fibrillation (AF)	3.7% 13/354 • Number of events 14 • Adverse events are collected through study completion, an average of 20 months All adverse events are collected as per ISO 14155 and medical device guidance (MEDDEV) 2.7/4. As per protocol, adverse events were collected irrespective of cohort allocation and therefore are not reported separately
Cardiac disorders Atrial Flutter	0.28% 1/354 • Number of events 1 • Adverse events are collected through study completion, an average of 20 months All adverse events are collected as per ISO 14155 and medical device guidance (MEDDEV) 2.7/4. As per protocol, adverse events were collected irrespective of cohort allocation and therefore are not reported separately
Cardiac disorders Atrial Tachycardia/Other SVT (e.g. AVRT, AVNRT, EAT)	0.85% 3/354 • Number of events 3 • Adverse events are collected through study completion, an average of 20 months All adverse events are collected as per ISO 14155 and medical device guidance (MEDDEV) 2.7/4. As per protocol, adverse events were collected irrespective of cohort allocation and therefore are not reported separately
Cardiac disorders Premature Ventricular Contractions (PVC)	0.56% 2/354 • Number of events 2 • Adverse events are collected through study completion, an average of 20 months All adverse events are collected as per ISO 14155 and medical device guidance (MEDDEV) 2.7/4. As per protocol, adverse events were collected irrespective of cohort allocation and therefore are not reported separately
Cardiac disorders Cardiac Arrest	0.56% 2/354 • Number of events 2 • Adverse events are collected through study completion, an average of 20 months All adverse events are collected as per ISO 14155 and medical device guidance (MEDDEV) 2.7/4. As per protocol, adverse events were collected irrespective of cohort allocation and therefore are not reported separately
Cardiac disorders Myocardial Infarction	0.56% 2/354 • Number of events 2 • Adverse events are collected through study completion, an average of 20 months All adverse events are collected as per ISO 14155 and medical device guidance (MEDDEV) 2.7/4. As per protocol, adverse events were collected irrespective of cohort allocation and therefore are not reported separately
Cardiac disorders Coronary Artery Disease	2.0% 7/354 • Number of events 8 • Adverse events are collected through study completion, an average of 20 months All adverse events are collected as per ISO 14155 and medical device guidance (MEDDEV) 2.7/4. As per protocol, adverse events were collected irrespective of cohort allocation and therefore are not reported separately
General disorders Peripheral Vascular Disease	1.1% 4/354 • Number of events 4 • Adverse events are collected through study completion, an average of 20 months All adverse events are collected as per ISO 14155 and medical device guidance (MEDDEV) 2.7/4. As per protocol, adverse events were collected irrespective of cohort allocation and therefore are not reported separately
Cardiac disorders Mitral Regurgitation	0.85% 3/354 • Number of events 3 • Adverse events are collected through study completion, an average of 20 months All adverse events are collected as per ISO 14155 and medical device guidance (MEDDEV) 2.7/4. As per protocol, adverse events were collected irrespective of cohort allocation and therefore are not reported separately
Cardiac disorders Tricuspid Regurgitation	0.28% 1/354 • Number of events 1 • Adverse events are collected through study completion, an average of 20 months All adverse events are collected as per ISO 14155 and medical device guidance (MEDDEV) 2.7/4. As per protocol, adverse events were collected irrespective of cohort allocation and therefore are not reported separately
Cardiac disorders Dizziness	0.28% 1/354 • Number of events 1 • Adverse events are collected through study completion, an average of 20 months All adverse events are collected as per ISO 14155 and medical device guidance (MEDDEV) 2.7/4. As per protocol, adverse events were collected irrespective of cohort allocation and therefore are not reported separately
Cardiac disorders Chest Pain - Ischemic	1.7% 6/354 • Number of events 6 • Adverse events are collected through study completion, an average of 20 months All adverse events are collected as per ISO 14155 and medical device guidance (MEDDEV) 2.7/4. As per protocol, adverse events were collected irrespective of cohort allocation and therefore are not reported separately
Cardiac disorders Chest Pain - Other	0.56% 2/354 • Number of events 2 • Adverse events are collected through study completion, an average of 20 months All adverse events are collected as per ISO 14155 and medical device guidance (MEDDEV) 2.7/4. As per protocol, adverse events were collected irrespective of cohort allocation and therefore are not reported separately
General disorders Other - Patient condition	0.56% 2/354 • Number of events 2 • Adverse events are collected through study completion, an average of 20 months All adverse events are collected as per ISO 14155 and medical device guidance (MEDDEV) 2.7/4. As per protocol, adverse events were collected irrespective of cohort allocation and therefore are not reported separately
Nervous system disorders Transient Ischemic Attack (TIA)	0.28% 1/354 • Number of events 1 • Adverse events are collected through study completion, an average of 20 months All adverse events are collected as per ISO 14155 and medical device guidance (MEDDEV) 2.7/4. As per protocol, adverse events were collected irrespective of cohort allocation and therefore are not reported separately
Nervous system disorders Cerebrovascular Accident (CVA)	0.56% 2/354 • Number of events 2 • Adverse events are collected through study completion, an average of 20 months All adverse events are collected as per ISO 14155 and medical device guidance (MEDDEV) 2.7/4. As per protocol, adverse events were collected irrespective of cohort allocation and therefore are not reported separately
Nervous system disorders Cerebrovascular accident (CVA) - ischemic	0.28% 1/354 • Number of events 1 • Adverse events are collected through study completion, an average of 20 months All adverse events are collected as per ISO 14155 and medical device guidance (MEDDEV) 2.7/4. As per protocol, adverse events were collected irrespective of cohort allocation and therefore are not reported separately
Respiratory, thoracic and mediastinal disorders Pneumothorax - unrelated procedure/device	0.28% 1/354 • Number of events 1 • Adverse events are collected through study completion, an average of 20 months All adverse events are collected as per ISO 14155 and medical device guidance (MEDDEV) 2.7/4. As per protocol, adverse events were collected irrespective of cohort allocation and therefore are not reported separately
General disorders Other - Unrelated to procedure/device	0.28% 1/354 • Number of events 1 • Adverse events are collected through study completion, an average of 20 months All adverse events are collected as per ISO 14155 and medical device guidance (MEDDEV) 2.7/4. As per protocol, adverse events were collected irrespective of cohort allocation and therefore are not reported separately
General disorders Adverse Reaction - Medication	1.1% 4/354 • Number of events 4 • Adverse events are collected through study completion, an average of 20 months All adverse events are collected as per ISO 14155 and medical device guidance (MEDDEV) 2.7/4. As per protocol, adverse events were collected irrespective of cohort allocation and therefore are not reported separately
General disorders Death	2.0% 7/354 • Number of events 7 • Adverse events are collected through study completion, an average of 20 months All adverse events are collected as per ISO 14155 and medical device guidance (MEDDEV) 2.7/4. As per protocol, adverse events were collected irrespective of cohort allocation and therefore are not reported separately
Product Issues System Infection	0.56% 2/354 • Number of events 2 • Adverse events are collected through study completion, an average of 20 months All adverse events are collected as per ISO 14155 and medical device guidance (MEDDEV) 2.7/4. As per protocol, adverse events were collected irrespective of cohort allocation and therefore are not reported separately
General disorders Fever and/or Virus	0.28% 1/354 • Number of events 1 • Adverse events are collected through study completion, an average of 20 months All adverse events are collected as per ISO 14155 and medical device guidance (MEDDEV) 2.7/4. As per protocol, adverse events were collected irrespective of cohort allocation and therefore are not reported separately
General disorders Physical Trauma	2.5% 9/354 • Number of events 9 • Adverse events are collected through study completion, an average of 20 months All adverse events are collected as per ISO 14155 and medical device guidance (MEDDEV) 2.7/4. As per protocol, adverse events were collected irrespective of cohort allocation and therefore are not reported separately
General disorders Localized Infection	0.28% 1/354 • Number of events 1 • Adverse events are collected through study completion, an average of 20 months All adverse events are collected as per ISO 14155 and medical device guidance (MEDDEV) 2.7/4. As per protocol, adverse events were collected irrespective of cohort allocation and therefore are not reported separately
Blood and lymphatic system disorders Hematological	0.28% 1/354 • Number of events 1 • Adverse events are collected through study completion, an average of 20 months All adverse events are collected as per ISO 14155 and medical device guidance (MEDDEV) 2.7/4. As per protocol, adverse events were collected irrespective of cohort allocation and therefore are not reported separately
Nervous system disorders Neurological	1.1% 4/354 • Number of events 4 • Adverse events are collected through study completion, an average of 20 months All adverse events are collected as per ISO 14155 and medical device guidance (MEDDEV) 2.7/4. As per protocol, adverse events were collected irrespective of cohort allocation and therefore are not reported separately
Gastrointestinal disorders Gastrointestinal	3.4% 12/354 • Number of events 15 • Adverse events are collected through study completion, an average of 20 months All adverse events are collected as per ISO 14155 and medical device guidance (MEDDEV) 2.7/4. As per protocol, adverse events were collected irrespective of cohort allocation and therefore are not reported separately
Respiratory, thoracic and mediastinal disorders Pulmonary	4.5% 16/354 • Number of events 16 • Adverse events are collected through study completion, an average of 20 months All adverse events are collected as per ISO 14155 and medical device guidance (MEDDEV) 2.7/4. As per protocol, adverse events were collected irrespective of cohort allocation and therefore are not reported separately
General disorders Other - Whole body	0.56% 2/354 • Number of events 3 • Adverse events are collected through study completion, an average of 20 months All adverse events are collected as per ISO 14155 and medical device guidance (MEDDEV) 2.7/4. As per protocol, adverse events were collected irrespective of cohort allocation and therefore are not reported separately
Reproductive system and breast disorders Genitourinary	0.85% 3/354 • Number of events 3 • Adverse events are collected through study completion, an average of 20 months All adverse events are collected as per ISO 14155 and medical device guidance (MEDDEV) 2.7/4. As per protocol, adverse events were collected irrespective of cohort allocation and therefore are not reported separately
Renal and urinary disorders Renal	1.1% 4/354 • Number of events 4 • Adverse events are collected through study completion, an average of 20 months All adverse events are collected as per ISO 14155 and medical device guidance (MEDDEV) 2.7/4. As per protocol, adverse events were collected irrespective of cohort allocation and therefore are not reported separately
Musculoskeletal and connective tissue disorders Musculoskeletal	1.4% 5/354 • Number of events 5 • Adverse events are collected through study completion, an average of 20 months All adverse events are collected as per ISO 14155 and medical device guidance (MEDDEV) 2.7/4. As per protocol, adverse events were collected irrespective of cohort allocation and therefore are not reported separately
General disorders Head, eyes, ears, nose, throat (HEENT)	1.1% 4/354 • Number of events 4 • Adverse events are collected through study completion, an average of 20 months All adverse events are collected as per ISO 14155 and medical device guidance (MEDDEV) 2.7/4. As per protocol, adverse events were collected irrespective of cohort allocation and therefore are not reported separately
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer	3.1% 11/354 • Number of events 15 • Adverse events are collected through study completion, an average of 20 months All adverse events are collected as per ISO 14155 and medical device guidance (MEDDEV) 2.7/4. As per protocol, adverse events were collected irrespective of cohort allocation and therefore are not reported separately
Product Issues Incisional/Superficial Infection (<= 30d post implant without explant)	6.2% 1/16 • Number of events 1 • Adverse events are collected through study completion, an average of 20 months All adverse events are collected as per ISO 14155 and medical device guidance (MEDDEV) 2.7/4. As per protocol, adverse events were collected irrespective of cohort allocation and therefore are not reported separately

Other adverse events

Other adverse events
Measure	Actively Enrolled Patients n=354 participants at risk Patients actively enrolled in the study, defined as subjects who met all eligibility criteria and who signed informed consent
Product Issues Extracardiac Stimulation - LV PG System	0.42% 1/239 • Number of events 1 • Adverse events are collected through study completion, an average of 20 months All adverse events are collected as per ISO 14155 and medical device guidance (MEDDEV) 2.7/4. As per protocol, adverse events were collected irrespective of cohort allocation and therefore are not reported separately
Product Issues Inappropriate tachy therapy - SVT - Defibrillation Lead	1.8% 3/171 • Number of events 3 • Adverse events are collected through study completion, an average of 20 months All adverse events are collected as per ISO 14155 and medical device guidance (MEDDEV) 2.7/4. As per protocol, adverse events were collected irrespective of cohort allocation and therefore are not reported separately
Product Issues Extracardiac Stimulation - LV Lead	2.6% 3/115 • Number of events 4 • Adverse events are collected through study completion, an average of 20 months All adverse events are collected as per ISO 14155 and medical device guidance (MEDDEV) 2.7/4. As per protocol, adverse events were collected irrespective of cohort allocation and therefore are not reported separately
Product Issues Hematoma - pocket (<= 30 days post-implant)	0.42% 1/239 • Number of events 1 • Adverse events are collected through study completion, an average of 20 months All adverse events are collected as per ISO 14155 and medical device guidance (MEDDEV) 2.7/4. As per protocol, adverse events were collected irrespective of cohort allocation and therefore are not reported separately
Cardiac disorders Dizziness - Heart Failure	0.28% 1/354 • Number of events 1 • Adverse events are collected through study completion, an average of 20 months All adverse events are collected as per ISO 14155 and medical device guidance (MEDDEV) 2.7/4. As per protocol, adverse events were collected irrespective of cohort allocation and therefore are not reported separately
Cardiac disorders Chest Pain - Heart Failure	0.28% 1/354 • Number of events 1 • Adverse events are collected through study completion, an average of 20 months All adverse events are collected as per ISO 14155 and medical device guidance (MEDDEV) 2.7/4. As per protocol, adverse events were collected irrespective of cohort allocation and therefore are not reported separately
Cardiac disorders Dyspnea - Heart Failure	3.4% 12/354 • Number of events 14 • Adverse events are collected through study completion, an average of 20 months All adverse events are collected as per ISO 14155 and medical device guidance (MEDDEV) 2.7/4. As per protocol, adverse events were collected irrespective of cohort allocation and therefore are not reported separately
Renal and urinary disorders Renal Failure/Insufficiency - Heart Failure	0.28% 1/354 • Number of events 1 • Adverse events are collected through study completion, an average of 20 months All adverse events are collected as per ISO 14155 and medical device guidance (MEDDEV) 2.7/4. As per protocol, adverse events were collected irrespective of cohort allocation and therefore are not reported separately
Cardiac disorders Dehydration - Heart Failure	0.28% 1/354 • Number of events 1 • Adverse events are collected through study completion, an average of 20 months All adverse events are collected as per ISO 14155 and medical device guidance (MEDDEV) 2.7/4. As per protocol, adverse events were collected irrespective of cohort allocation and therefore are not reported separately
Cardiac disorders Heart Failure Symptoms - Unspecified	1.4% 5/354 • Number of events 5 • Adverse events are collected through study completion, an average of 20 months All adverse events are collected as per ISO 14155 and medical device guidance (MEDDEV) 2.7/4. As per protocol, adverse events were collected irrespective of cohort allocation and therefore are not reported separately
Cardiac disorders Multiple Heart Failure Symptoms	1.7% 6/354 • Number of events 6 • Adverse events are collected through study completion, an average of 20 months All adverse events are collected as per ISO 14155 and medical device guidance (MEDDEV) 2.7/4. As per protocol, adverse events were collected irrespective of cohort allocation and therefore are not reported separately
Cardiac disorders Other - Heart failure patient condition	0.56% 2/354 • Number of events 2 • Adverse events are collected through study completion, an average of 20 months All adverse events are collected as per ISO 14155 and medical device guidance (MEDDEV) 2.7/4. As per protocol, adverse events were collected irrespective of cohort allocation and therefore are not reported separately
Cardiac disorders Ventricular Fibrillation (VF)	0.85% 3/354 • Number of events 3 • Adverse events are collected through study completion, an average of 20 months All adverse events are collected as per ISO 14155 and medical device guidance (MEDDEV) 2.7/4. As per protocol, adverse events were collected irrespective of cohort allocation and therefore are not reported separately
Cardiac disorders Ventricular Tachycardia (VT)/Monomorphic VT	3.1% 11/354 • Number of events 46 • Adverse events are collected through study completion, an average of 20 months All adverse events are collected as per ISO 14155 and medical device guidance (MEDDEV) 2.7/4. As per protocol, adverse events were collected irrespective of cohort allocation and therefore are not reported separately
Cardiac disorders Nonsustained ventricular tachycardia (NSVT)	0.56% 2/354 • Number of events 2 • Adverse events are collected through study completion, an average of 20 months All adverse events are collected as per ISO 14155 and medical device guidance (MEDDEV) 2.7/4. As per protocol, adverse events were collected irrespective of cohort allocation and therefore are not reported separately
Cardiac disorders Atrial Fibrillation (AF)	4.0% 14/354 • Number of events 15 • Adverse events are collected through study completion, an average of 20 months All adverse events are collected as per ISO 14155 and medical device guidance (MEDDEV) 2.7/4. As per protocol, adverse events were collected irrespective of cohort allocation and therefore are not reported separately
Cardiac disorders Atrial Flutter	0.28% 1/354 • Number of events 1 • Adverse events are collected through study completion, an average of 20 months All adverse events are collected as per ISO 14155 and medical device guidance (MEDDEV) 2.7/4. As per protocol, adverse events were collected irrespective of cohort allocation and therefore are not reported separately
Cardiac disorders Atrial Tachycardia/Other SVT (e.g. AVRT, AVNRT, EAT)	0.85% 3/354 • Number of events 3 • Adverse events are collected through study completion, an average of 20 months All adverse events are collected as per ISO 14155 and medical device guidance (MEDDEV) 2.7/4. As per protocol, adverse events were collected irrespective of cohort allocation and therefore are not reported separately
Cardiac disorders Hypotension/Orthostatic Hypotension	0.28% 1/354 • Number of events 1 • Adverse events are collected through study completion, an average of 20 months All adverse events are collected as per ISO 14155 and medical device guidance (MEDDEV) 2.7/4. As per protocol, adverse events were collected irrespective of cohort allocation and therefore are not reported separately
Cardiac disorders Hypertension/Hypertensive Crisis	0.28% 1/354 • Number of events 1 • Adverse events are collected through study completion, an average of 20 months All adverse events are collected as per ISO 14155 and medical device guidance (MEDDEV) 2.7/4. As per protocol, adverse events were collected irrespective of cohort allocation and therefore are not reported separately
Cardiac disorders Mitral Regurgitation	0.28% 1/354 • Number of events 1 • Adverse events are collected through study completion, an average of 20 months All adverse events are collected as per ISO 14155 and medical device guidance (MEDDEV) 2.7/4. As per protocol, adverse events were collected irrespective of cohort allocation and therefore are not reported separately
Cardiac disorders Syncope	0.28% 1/354 • Number of events 1 • Adverse events are collected through study completion, an average of 20 months All adverse events are collected as per ISO 14155 and medical device guidance (MEDDEV) 2.7/4. As per protocol, adverse events were collected irrespective of cohort allocation and therefore are not reported separately
Cardiac disorders Dizziness	0.85% 3/354 • Number of events 4 • Adverse events are collected through study completion, an average of 20 months All adverse events are collected as per ISO 14155 and medical device guidance (MEDDEV) 2.7/4. As per protocol, adverse events were collected irrespective of cohort allocation and therefore are not reported separately
Cardiac disorders Dyspnea	0.56% 2/354 • Number of events 2 • Adverse events are collected through study completion, an average of 20 months All adverse events are collected as per ISO 14155 and medical device guidance (MEDDEV) 2.7/4. As per protocol, adverse events were collected irrespective of cohort allocation and therefore are not reported separately
General disorders Other - Patient condition	0.28% 1/354 • Number of events 1 • Adverse events are collected through study completion, an average of 20 months All adverse events are collected as per ISO 14155 and medical device guidance (MEDDEV) 2.7/4. As per protocol, adverse events were collected irrespective of cohort allocation and therefore are not reported separately
Nervous system disorders Transient Ischemic Attack (TIA)	0.28% 1/354 • Number of events 1 • Adverse events are collected through study completion, an average of 20 months All adverse events are collected as per ISO 14155 and medical device guidance (MEDDEV) 2.7/4. As per protocol, adverse events were collected irrespective of cohort allocation and therefore are not reported separately
Cardiac disorders Intracardiac thrombus	0.28% 1/354 • Number of events 1 • Adverse events are collected through study completion, an average of 20 months All adverse events are collected as per ISO 14155 and medical device guidance (MEDDEV) 2.7/4. As per protocol, adverse events were collected irrespective of cohort allocation and therefore are not reported separately
General disorders Hemorrhage - unrelated procedure/device	0.28% 1/354 • Number of events 1 • Adverse events are collected through study completion, an average of 20 months All adverse events are collected as per ISO 14155 and medical device guidance (MEDDEV) 2.7/4. As per protocol, adverse events were collected irrespective of cohort allocation and therefore are not reported separately
Respiratory, thoracic and mediastinal disorders Pleural Effusion - unrelated procedure/device	0.56% 2/354 • Number of events 2 • Adverse events are collected through study completion, an average of 20 months All adverse events are collected as per ISO 14155 and medical device guidance (MEDDEV) 2.7/4. As per protocol, adverse events were collected irrespective of cohort allocation and therefore are not reported separately
General disorders Adverse Reaction - Medication	0.56% 2/354 • Number of events 2 • Adverse events are collected through study completion, an average of 20 months All adverse events are collected as per ISO 14155 and medical device guidance (MEDDEV) 2.7/4. As per protocol, adverse events were collected irrespective of cohort allocation and therefore are not reported separately
Product Issues System Infection	0.28% 1/354 • Number of events 1 • Adverse events are collected through study completion, an average of 20 months All adverse events are collected as per ISO 14155 and medical device guidance (MEDDEV) 2.7/4. As per protocol, adverse events were collected irrespective of cohort allocation and therefore are not reported separately
General disorders Fever and/or Virus	1.4% 5/354 • Number of events 5 • Adverse events are collected through study completion, an average of 20 months All adverse events are collected as per ISO 14155 and medical device guidance (MEDDEV) 2.7/4. As per protocol, adverse events were collected irrespective of cohort allocation and therefore are not reported separately
General disorders Physical Trauma	2.5% 9/354 • Number of events 10 • Adverse events are collected through study completion, an average of 20 months All adverse events are collected as per ISO 14155 and medical device guidance (MEDDEV) 2.7/4. As per protocol, adverse events were collected irrespective of cohort allocation and therefore are not reported separately
Blood and lymphatic system disorders Hematological	0.56% 2/354 • Number of events 2 • Adverse events are collected through study completion, an average of 20 months All adverse events are collected as per ISO 14155 and medical device guidance (MEDDEV) 2.7/4. As per protocol, adverse events were collected irrespective of cohort allocation and therefore are not reported separately
Nervous system disorders Neurological	0.28% 1/354 • Number of events 1 • Adverse events are collected through study completion, an average of 20 months All adverse events are collected as per ISO 14155 and medical device guidance (MEDDEV) 2.7/4. As per protocol, adverse events were collected irrespective of cohort allocation and therefore are not reported separately
Gastrointestinal disorders Gastrointestinal	1.4% 5/354 • Number of events 5 • Adverse events are collected through study completion, an average of 20 months All adverse events are collected as per ISO 14155 and medical device guidance (MEDDEV) 2.7/4. As per protocol, adverse events were collected irrespective of cohort allocation and therefore are not reported separately
Respiratory, thoracic and mediastinal disorders Pulmonary	0.28% 1/354 • Number of events 1 • Adverse events are collected through study completion, an average of 20 months All adverse events are collected as per ISO 14155 and medical device guidance (MEDDEV) 2.7/4. As per protocol, adverse events were collected irrespective of cohort allocation and therefore are not reported separately
Reproductive system and breast disorders Genitourinary	0.28% 1/354 • Number of events 1 • Adverse events are collected through study completion, an average of 20 months All adverse events are collected as per ISO 14155 and medical device guidance (MEDDEV) 2.7/4. As per protocol, adverse events were collected irrespective of cohort allocation and therefore are not reported separately
Renal and urinary disorders Renal	6.8% 24/354 • Number of events 30 • Adverse events are collected through study completion, an average of 20 months All adverse events are collected as per ISO 14155 and medical device guidance (MEDDEV) 2.7/4. As per protocol, adverse events were collected irrespective of cohort allocation and therefore are not reported separately
Musculoskeletal and connective tissue disorders Musculoskeletal	0.56% 2/354 • Number of events 2 • Adverse events are collected through study completion, an average of 20 months All adverse events are collected as per ISO 14155 and medical device guidance (MEDDEV) 2.7/4. As per protocol, adverse events were collected irrespective of cohort allocation and therefore are not reported separately
Skin and subcutaneous tissue disorders Integumentary	0.28% 1/354 • Number of events 3 • Adverse events are collected through study completion, an average of 20 months All adverse events are collected as per ISO 14155 and medical device guidance (MEDDEV) 2.7/4. As per protocol, adverse events were collected irrespective of cohort allocation and therefore are not reported separately
General disorders Head, eyes, ears, nose, throat (HEENT)	1.1% 4/354 • Number of events 4 • Adverse events are collected through study completion, an average of 20 months All adverse events are collected as per ISO 14155 and medical device guidance (MEDDEV) 2.7/4. As per protocol, adverse events were collected irrespective of cohort allocation and therefore are not reported separately
Endocrine disorders Endocrine	0.56% 2/354 • Number of events 2 • Adverse events are collected through study completion, an average of 20 months All adverse events are collected as per ISO 14155 and medical device guidance (MEDDEV) 2.7/4. As per protocol, adverse events were collected irrespective of cohort allocation and therefore are not reported separately
Product Issues Inappropriate Tachy Therapy - Other - PG	6.2% 1/16 • Number of events 1 • Adverse events are collected through study completion, an average of 20 months All adverse events are collected as per ISO 14155 and medical device guidance (MEDDEV) 2.7/4. As per protocol, adverse events were collected irrespective of cohort allocation and therefore are not reported separately

Additional Information

Caroline Beaudoint

Boston Scientific

Phone: +32479904163

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee There IS an agreement between the Principal Investigator and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Publication restrictions are in place

Restriction type: OTHER