Trial Outcomes & Findings for Safety and Performance Study of the Reliance 4-Front Lead (NCT NCT01772576)
NCT ID: NCT01772576
Last Updated: 2017-07-02
Results Overview
Lead-related Complication-Free Rate (CFR) from Implant through 3 Months Post-Implant.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
167 participants
Primary outcome timeframe
3-months follow-up
Results posted on
2017-07-02
Participant Flow
167 patients were enrolled in the study. Patients were considered enrolled when the consent form was signed regardless whether they received the RELIANCE 4FRONT lead or not. Recruitment started on 22 November 2012. Last patient was enrolled 9 March 2014.
No wash out or run-in period was planned for the study. 3 patients did not receive the study lead: lead not available at site, wrong lead chosen and patient needed MRI (magnet resonance imaging) compatible lead, while the RELIANCE 4FRONT lead was not labeled MRI compatible.
Participant milestones
| Measure |
Reliance 4-Front
Single arm, all patients were implanted with the Reliance 4-Front lead
Reliance 4-Front lead implantation: The patients selected for participation were from the investigator's general patient population with an indication for implantation of a single or dual chamber ICD or CRT-D system.
|
|---|---|
|
Overall Study
STARTED
|
167
|
|
Overall Study
COMPLETED
|
133
|
|
Overall Study
NOT COMPLETED
|
34
|
Reasons for withdrawal
| Measure |
Reliance 4-Front
Single arm, all patients were implanted with the Reliance 4-Front lead
Reliance 4-Front lead implantation: The patients selected for participation were from the investigator's general patient population with an indication for implantation of a single or dual chamber ICD or CRT-D system.
|
|---|---|
|
Overall Study
Death
|
15
|
|
Overall Study
Protocol Violation
|
1
|
|
Overall Study
Lost to Follow-up
|
3
|
|
Overall Study
Study device not used
|
3
|
|
Overall Study
Adverse Event
|
6
|
|
Overall Study
Withdrawal by Subject
|
6
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Reliance 4-Front
n=167 Participants
Single arm, all patients will be implanted with the Reliance 4-Front lead
Reliance 4-Front lead implantation: The patients selected for participation should be from the investigator's general patient population with an indication for implantation of a single or dual chamber ICD or CRT-D system.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=167 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
65 Participants
n=167 Participants
|
|
Age, Categorical
>=65 years
|
102 Participants
n=167 Participants
|
|
Age, Continuous
|
65.26 years
STANDARD_DEVIATION 10.94 • n=167 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=167 Participants
|
|
Sex: Female, Male
Male
|
138 Participants
n=167 Participants
|
|
Region of Enrollment
Austria
|
10 participants
n=167 Participants
|
|
Region of Enrollment
Sweden
|
9 participants
n=167 Participants
|
|
Region of Enrollment
China
|
10 participants
n=167 Participants
|
|
Region of Enrollment
Denmark
|
25 participants
n=167 Participants
|
|
Region of Enrollment
United Kingdom
|
22 participants
n=167 Participants
|
|
Region of Enrollment
Italy
|
15 participants
n=167 Participants
|
|
Region of Enrollment
Israel
|
44 participants
n=167 Participants
|
|
Region of Enrollment
France
|
4 participants
n=167 Participants
|
|
Region of Enrollment
Portugal
|
4 participants
n=167 Participants
|
|
Region of Enrollment
Germany
|
20 participants
n=167 Participants
|
|
Region of Enrollment
Spain
|
4 participants
n=167 Participants
|
PRIMARY outcome
Timeframe: 3-months follow-upPopulation: Patients enrolled in the study and having received the RELIANCE 4FRONT active fixation lead
Lead-related Complication-Free Rate (CFR) from Implant through 3 Months Post-Implant.
Outcome measures
| Measure |
Reliance 4-Front
n=164 Participants
Single arm, all patients were implanted with the Reliance 4-Front lead
Reliance 4-Front lead implantation: The patients selected for participation were from the investigator's general patient population with an indication for implantation of a single or dual chamber ICD or CRT-D system.
|
|---|---|
|
Complication Free Rate
|
96.3 percentage of all subjects
Interval 92.9 to 99.7
|
SECONDARY outcome
Timeframe: 3 months through 15 months post implantPopulation: 156 patients remained after 3 months in the study without lead related complication. Those were used for the secondary endpoint.
Lead-related Complication-Free Rate from 3 Months through 15 Months Post-Implant.
Outcome measures
| Measure |
Reliance 4-Front
n=156 Participants
Single arm, all patients were implanted with the Reliance 4-Front lead
Reliance 4-Front lead implantation: The patients selected for participation were from the investigator's general patient population with an indication for implantation of a single or dual chamber ICD or CRT-D system.
|
|---|---|
|
Complication Free Rate
|
98.7 percentage of total participants
Interval 95.8 to 100.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 3 Months through 24 Months Post-ImplantPopulation: Patients remaining after the 3 months follow-up in the study until the 24 months follow-up.
Lead-related Complication-Free Rate from 3 Months through 24 Months Post-Implant
Outcome measures
| Measure |
Reliance 4-Front
n=156 Participants
Single arm, all patients were implanted with the Reliance 4-Front lead
Reliance 4-Front lead implantation: The patients selected for participation were from the investigator's general patient population with an indication for implantation of a single or dual chamber ICD or CRT-D system.
|
|---|---|
|
Complication Free Rate
|
98.7 percentage of all participants
Interval 95.8 to 100.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 3-months post-implantPopulation: Patients having undergone the 3 months follow-up visit.
Pacing Threshold at 0.5 ms pulse width at 3 Months Post-Implant
Outcome measures
| Measure |
Reliance 4-Front
n=144 Participants
Single arm, all patients were implanted with the Reliance 4-Front lead
Reliance 4-Front lead implantation: The patients selected for participation were from the investigator's general patient population with an indication for implantation of a single or dual chamber ICD or CRT-D system.
|
|---|---|
|
Pacing Threshold
|
0.53 Volt
Interval 0.48 to 0.58
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 3 Months Post-ImplantPopulation: Patients having undergone the 3 months follow-up
Sensed Amplitude at 3 Months Post-Implant
Outcome measures
| Measure |
Reliance 4-Front
n=144 Participants
Single arm, all patients were implanted with the Reliance 4-Front lead
Reliance 4-Front lead implantation: The patients selected for participation were from the investigator's general patient population with an indication for implantation of a single or dual chamber ICD or CRT-D system.
|
|---|---|
|
Sensed Amplitude
|
18.1 mV
Interval 17.1 to 19.1
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 3 Months Post-ImplantPopulation: Patients with 3 month follow-up
Pacing Impedance at 3 Months Post-Implant
Outcome measures
| Measure |
Reliance 4-Front
n=150 Participants
Single arm, all patients were implanted with the Reliance 4-Front lead
Reliance 4-Front lead implantation: The patients selected for participation were from the investigator's general patient population with an indication for implantation of a single or dual chamber ICD or CRT-D system.
|
|---|---|
|
Pacing Impedance
|
474 Ohm
Interval 457.0 to 491.0
|
Adverse Events
Reliance 4-Front
Serious events: 89 serious events
Other events: 69 other events
Deaths: 14 deaths
Serious adverse events
| Measure |
Reliance 4-Front
n=167 participants at risk
Single arm, all patients were implanted with the Reliance 4-Front lead
Reliance 4-Front lead implantation: The patients selected for participation were from the investigator's general patient population with an indication for implantation of a single or dual chamber ICD or CRT-D system.
|
|---|---|
|
Cardiac disorders
Inappropriate tachy therapy - SVT
|
0.61%
1/164 • Number of events 1 • Adverse events were collected from enrollment through 24 months.
Definitions do not differ from clinicaltrials.gov definitions
|
|
Cardiac disorders
Inappropriate tachy therapy - Other
|
0.61%
1/164 • Number of events 1 • Adverse events were collected from enrollment through 24 months.
Definitions do not differ from clinicaltrials.gov definitions
|
|
Skin and subcutaneous tissue disorders
Erosion
|
0.61%
1/164 • Number of events 1 • Adverse events were collected from enrollment through 24 months.
Definitions do not differ from clinicaltrials.gov definitions
|
|
Infections and infestations
Infection (> 30 days post-implant)
|
1.8%
3/164 • Number of events 3 • Adverse events were collected from enrollment through 24 months.
Definitions do not differ from clinicaltrials.gov definitions
|
|
Psychiatric disorders
Psychological effect due to device therapy
|
1.2%
2/164 • Number of events 2 • Adverse events were collected from enrollment through 24 months.
Definitions do not differ from clinicaltrials.gov definitions
|
|
Skin and subcutaneous tissue disorders
Post-surgical wound discomfort
|
0.61%
1/164 • Number of events 1 • Adverse events were collected from enrollment through 24 months.
Definitions do not differ from clinicaltrials.gov definitions
|
|
Skin and subcutaneous tissue disorders
Post-surgical pocket hemorrhage
|
0.61%
1/164 • Number of events 1 • Adverse events were collected from enrollment through 24 months.
Definitions do not differ from clinicaltrials.gov definitions
|
|
General disorders
Adverse reaction - General
|
0.61%
1/164 • Number of events 1 • Adverse events were collected from enrollment through 24 months.
Definitions do not differ from clinicaltrials.gov definitions
|
|
Injury, poisoning and procedural complications
Hemorrhage
|
0.61%
1/164 • Number of events 1 • Adverse events were collected from enrollment through 24 months.
Definitions do not differ from clinicaltrials.gov definitions
|
|
Injury, poisoning and procedural complications
Hematoma - Pocket (<=30 days post-implant)
|
1.2%
2/164 • Number of events 2 • Adverse events were collected from enrollment through 24 months.
Definitions do not differ from clinicaltrials.gov definitions
|
|
General disorders
Unable to capture - RV
|
1.2%
2/164 • Number of events 2 • Adverse events were collected from enrollment through 24 months.
Definitions do not differ from clinicaltrials.gov definitions
|
|
General disorders
Elevated threshold - RV
|
0.61%
1/164 • Number of events 1 • Adverse events were collected from enrollment through 24 months.
Definitions do not differ from clinicaltrials.gov definitions
|
|
General disorders
Impedance > 2000 ohms - RV
|
1.2%
2/164 • Number of events 2 • Adverse events were collected from enrollment through 24 months.
Definitions do not differ from clinicaltrials.gov definitions
|
|
General disorders
Dislodgment - Multiple signs - RV
|
0.61%
1/164 • Number of events 1 • Adverse events were collected from enrollment through 24 months.
Definitions do not differ from clinicaltrials.gov definitions
|
|
General disorders
Dislodgment - No reported signs - RV
|
0.61%
1/164 • Number of events 1 • Adverse events were collected from enrollment through 24 months.
Definitions do not differ from clinicaltrials.gov definitions
|
|
General disorders
Elevated threshold - LV
|
0.61%
1/164 • Number of events 1 • Adverse events were collected from enrollment through 24 months.
Definitions do not differ from clinicaltrials.gov definitions
|
|
General disorders
Dislodgment - Elevated threshold - LV
|
0.61%
1/164 • Number of events 1 • Adverse events were collected from enrollment through 24 months.
Definitions do not differ from clinicaltrials.gov definitions
|
|
General disorders
Dislodgment - No reported signs - LV
|
0.61%
1/164 • Number of events 1 • Adverse events were collected from enrollment through 24 months.
Definitions do not differ from clinicaltrials.gov definitions
|
|
Injury, poisoning and procedural complications
Pneumothorax - Procedure
|
0.61%
1/164 • Number of events 1 • Adverse events were collected from enrollment through 24 months.
Definitions do not differ from clinicaltrials.gov definitions
|
|
Vascular disorders
Coronary venous dissection
|
0.61%
1/164 • Number of events 1 • Adverse events were collected from enrollment through 24 months.
Definitions do not differ from clinicaltrials.gov definitions
|
|
General disorders
Other - Lead - Procedure: implant failure
|
0.61%
1/164 • Number of events 1 • Adverse events were collected from enrollment through 24 months.
Definitions do not differ from clinicaltrials.gov definitions
|
|
Cardiac disorders
Pulseless electrical activity (PEA)
|
0.60%
1/167 • Number of events 1 • Adverse events were collected from enrollment through 24 months.
Definitions do not differ from clinicaltrials.gov definitions
|
|
Cardiac disorders
VENTRICULAR TACHYARRHYTHMIAS
|
0.60%
1/167 • Number of events 1 • Adverse events were collected from enrollment through 24 months.
Definitions do not differ from clinicaltrials.gov definitions
|
|
Cardiac disorders
Ventricular fibrillation (VF)
|
2.4%
4/167 • Number of events 5 • Adverse events were collected from enrollment through 24 months.
Definitions do not differ from clinicaltrials.gov definitions
|
|
Cardiac disorders
Ventricular tachycardia (VT)
|
3.0%
5/167 • Number of events 9 • Adverse events were collected from enrollment through 24 months.
Definitions do not differ from clinicaltrials.gov definitions
|
|
Cardiac disorders
Torsades des pointes
|
1.2%
2/167 • Number of events 2 • Adverse events were collected from enrollment through 24 months.
Definitions do not differ from clinicaltrials.gov definitions
|
|
Cardiac disorders
Atrial fibrillation (AF)
|
5.4%
9/167 • Number of events 14 • Adverse events were collected from enrollment through 24 months.
Definitions do not differ from clinicaltrials.gov definitions
|
|
Cardiac disorders
Atrial flutter
|
1.2%
2/167 • Number of events 2 • Adverse events were collected from enrollment through 24 months.
Definitions do not differ from clinicaltrials.gov definitions
|
|
Cardiac disorders
Sinus tachycardia
|
0.60%
1/167 • Number of events 1 • Adverse events were collected from enrollment through 24 months.
Definitions do not differ from clinicaltrials.gov definitions
|
|
Cardiac disorders
Premature ventricular contractions (PVC)
|
0.60%
1/167 • Number of events 1 • Adverse events were collected from enrollment through 24 months.
Definitions do not differ from clinicaltrials.gov definitions
|
|
Cardiac disorders
Syncope - Heart failure
|
1.8%
3/167 • Number of events 3 • Adverse events were collected from enrollment through 24 months.
Definitions do not differ from clinicaltrials.gov definitions
|
|
Cardiac disorders
Chest pain - Heart failure
|
1.2%
2/167 • Number of events 2 • Adverse events were collected from enrollment through 24 months.
Definitions do not differ from clinicaltrials.gov definitions
|
|
Cardiac disorders
Dyspnea - Heart failure
|
3.0%
5/167 • Number of events 5 • Adverse events were collected from enrollment through 24 months.
Definitions do not differ from clinicaltrials.gov definitions
|
|
Cardiac disorders
Peripheral edema - Heart failure
|
0.60%
1/167 • Number of events 1 • Adverse events were collected from enrollment through 24 months.
Definitions do not differ from clinicaltrials.gov definitions
|
|
Cardiac disorders
Pulmonary edema - Heart failure
|
1.8%
3/167 • Number of events 7 • Adverse events were collected from enrollment through 24 months.
Definitions do not differ from clinicaltrials.gov definitions
|
|
Cardiac disorders
Fatigue - Heart failure
|
0.60%
1/167 • Number of events 1 • Adverse events were collected from enrollment through 24 months.
Definitions do not differ from clinicaltrials.gov definitions
|
|
Cardiac disorders
Dehydration - Heart failure
|
0.60%
1/167 • Number of events 1 • Adverse events were collected from enrollment through 24 months.
Definitions do not differ from clinicaltrials.gov definitions
|
|
Cardiac disorders
Heart failure symptoms - Unspecified
|
2.4%
4/167 • Number of events 4 • Adverse events were collected from enrollment through 24 months.
Definitions do not differ from clinicaltrials.gov definitions
|
|
Cardiac disorders
Multiple heart failure symptoms
|
5.4%
9/167 • Number of events 12 • Adverse events were collected from enrollment through 24 months.
Definitions do not differ from clinicaltrials.gov definitions
|
|
Cardiac disorders
Multi-system failure - Heart failure
|
4.8%
8/167 • Number of events 8 • Adverse events were collected from enrollment through 24 months.
Definitions do not differ from clinicaltrials.gov definitions
|
|
Vascular disorders
Coronary Artery Disease
|
1.8%
3/167 • Number of events 3 • Adverse events were collected from enrollment through 24 months.
Definitions do not differ from clinicaltrials.gov definitions
|
|
Vascular disorders
Peripheral vascular disease
|
1.8%
3/167 • Number of events 4 • Adverse events were collected from enrollment through 24 months.
Definitions do not differ from clinicaltrials.gov definitions
|
|
Vascular disorders
Syncope
|
3.6%
6/167 • Number of events 6 • Adverse events were collected from enrollment through 24 months.
Definitions do not differ from clinicaltrials.gov definitions
|
|
Cardiac disorders
Chest pain - Ischemic
|
1.2%
2/167 • Number of events 3 • Adverse events were collected from enrollment through 24 months.
Definitions do not differ from clinicaltrials.gov definitions
|
|
Cardiac disorders
Chest pain - Other
|
3.6%
6/167 • Number of events 11 • Adverse events were collected from enrollment through 24 months.
Definitions do not differ from clinicaltrials.gov definitions
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
1.2%
2/167 • Number of events 2 • Adverse events were collected from enrollment through 24 months.
Definitions do not differ from clinicaltrials.gov definitions
|
|
General disorders
Multiple symptoms
|
1.2%
2/167 • Number of events 2 • Adverse events were collected from enrollment through 24 months.
Definitions do not differ from clinicaltrials.gov definitions
|
|
Vascular disorders
Cerebrovascular accident (CVA)
|
2.4%
4/167 • Number of events 4 • Adverse events were collected from enrollment through 24 months.
Definitions do not differ from clinicaltrials.gov definitions
|
|
Respiratory, thoracic and mediastinal disorders
COPD Exacerbation
|
1.2%
2/167 • Number of events 3 • Adverse events were collected from enrollment through 24 months.
Definitions do not differ from clinicaltrials.gov definitions
|
|
General disorders
Death
|
2.4%
4/167 • Number of events 4 • Adverse events were collected from enrollment through 24 months.
Definitions do not differ from clinicaltrials.gov definitions
|
|
Infections and infestations
Systemic infection
|
0.60%
1/167 • Number of events 1 • Adverse events were collected from enrollment through 24 months.
Definitions do not differ from clinicaltrials.gov definitions
|
|
General disorders
Fever
|
0.60%
1/167 • Number of events 1 • Adverse events were collected from enrollment through 24 months.
Definitions do not differ from clinicaltrials.gov definitions
|
|
Injury, poisoning and procedural complications
Physical trauma
|
0.60%
1/167 • Number of events 1 • Adverse events were collected from enrollment through 24 months.
Definitions do not differ from clinicaltrials.gov definitions
|
|
Blood and lymphatic system disorders
Abnormal laboratory values
|
0.60%
1/167 • Number of events 2 • Adverse events were collected from enrollment through 24 months.
Definitions do not differ from clinicaltrials.gov definitions
|
|
Blood and lymphatic system disorders
Hematological
|
3.0%
5/167 • Number of events 8 • Adverse events were collected from enrollment through 24 months.
Definitions do not differ from clinicaltrials.gov definitions
|
|
Nervous system disorders
Neurological
|
1.2%
2/167 • Number of events 3 • Adverse events were collected from enrollment through 24 months.
Definitions do not differ from clinicaltrials.gov definitions
|
|
Gastrointestinal disorders
Gastrointestinal
|
6.6%
11/167 • Number of events 16 • Adverse events were collected from enrollment through 24 months.
Definitions do not differ from clinicaltrials.gov definitions
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary
|
5.4%
9/167 • Number of events 13 • Adverse events were collected from enrollment through 24 months.
Definitions do not differ from clinicaltrials.gov definitions
|
|
Renal and urinary disorders
Genitourinary
|
2.4%
4/167 • Number of events 7 • Adverse events were collected from enrollment through 24 months.
Definitions do not differ from clinicaltrials.gov definitions
|
|
Renal and urinary disorders
Renal
|
0.60%
1/167 • Number of events 1 • Adverse events were collected from enrollment through 24 months.
Definitions do not differ from clinicaltrials.gov definitions
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal
|
2.4%
4/167 • Number of events 4 • Adverse events were collected from enrollment through 24 months.
Definitions do not differ from clinicaltrials.gov definitions
|
|
Psychiatric disorders
Psychological
|
0.60%
1/167 • Number of events 1 • Adverse events were collected from enrollment through 24 months.
Definitions do not differ from clinicaltrials.gov definitions
|
|
Skin and subcutaneous tissue disorders
Integumentary
|
1.2%
2/167 • Number of events 2 • Adverse events were collected from enrollment through 24 months.
Definitions do not differ from clinicaltrials.gov definitions
|
|
General disorders
Head, eyes, ears, nose, throat (HEENT)
|
0.60%
1/167 • Number of events 1 • Adverse events were collected from enrollment through 24 months.
Definitions do not differ from clinicaltrials.gov definitions
|
|
Endocrine disorders
Endocrine
|
1.8%
3/167 • Number of events 3 • Adverse events were collected from enrollment through 24 months.
Definitions do not differ from clinicaltrials.gov definitions
|
|
General disorders
Cancer
|
3.0%
5/167 • Number of events 6 • Adverse events were collected from enrollment through 24 months.
Definitions do not differ from clinicaltrials.gov definitions
|
|
General disorders
Multi-system failure
|
0.60%
1/167 • Number of events 1 • Adverse events were collected from enrollment through 24 months.
Definitions do not differ from clinicaltrials.gov definitions
|
|
General disorders
Adverse drug reaction
|
1.2%
2/167 • Number of events 2 • Adverse events were collected from enrollment through 24 months.
Definitions do not differ from clinicaltrials.gov definitions
|
Other adverse events
| Measure |
Reliance 4-Front
n=167 participants at risk
Single arm, all patients were implanted with the Reliance 4-Front lead
Reliance 4-Front lead implantation: The patients selected for participation were from the investigator's general patient population with an indication for implantation of a single or dual chamber ICD or CRT-D system.
|
|---|---|
|
Cardiac disorders
Unable to capture - RA
|
0.61%
1/164 • Number of events 1 • Adverse events were collected from enrollment through 24 months.
Definitions do not differ from clinicaltrials.gov definitions
|
|
Cardiac disorders
Inappropriate tachy therapy - Other
|
0.61%
1/164 • Number of events 2 • Adverse events were collected from enrollment through 24 months.
Definitions do not differ from clinicaltrials.gov definitions
|
|
Skin and subcutaneous tissue disorders
Post-surgical wound discomfort
|
0.61%
1/164 • Number of events 2 • Adverse events were collected from enrollment through 24 months.
Definitions do not differ from clinicaltrials.gov definitions
|
|
Skin and subcutaneous tissue disorders
Post-surgical infection (<= 30 days post-implant)
|
1.8%
3/164 • Number of events 3 • Adverse events were collected from enrollment through 24 months.
Definitions do not differ from clinicaltrials.gov definitions
|
|
General disorders
Adverse reaction - General
|
1.8%
3/167 • Number of events 3 • Adverse events were collected from enrollment through 24 months.
Definitions do not differ from clinicaltrials.gov definitions
|
|
Respiratory, thoracic and mediastinal disorders
Adverse reaction - Respiratory
|
0.61%
1/164 • Number of events 1 • Adverse events were collected from enrollment through 24 months.
Definitions do not differ from clinicaltrials.gov definitions
|
|
Respiratory, thoracic and mediastinal disorders
Chest pain
|
0.61%
1/164 • Number of events 1 • Adverse events were collected from enrollment through 24 months.
Definitions do not differ from clinicaltrials.gov definitions
|
|
Injury, poisoning and procedural complications
Hematoma - Pocket (<=30 days post-implant)
|
4.9%
8/164 • Number of events 8 • Adverse events were collected from enrollment through 24 months.
Definitions do not differ from clinicaltrials.gov definitions
|
|
Injury, poisoning and procedural complications
Other-PG system-Procedure: Other non system related
|
0.61%
1/164 • Number of events 1 • Adverse events were collected from enrollment through 24 months.
Definitions do not differ from clinicaltrials.gov definitions
|
|
General disorders
Dislodgment - Multiple signs - RV
|
0.61%
1/164 • Number of events 1 • Adverse events were collected from enrollment through 24 months.
Definitions do not differ from clinicaltrials.gov definitions
|
|
General disorders
Unable to capture - LV
|
0.61%
1/164 • Number of events 1 • Adverse events were collected from enrollment through 24 months.
Definitions do not differ from clinicaltrials.gov definitions
|
|
General disorders
Elevated threshold - LV
|
1.8%
3/164 • Number of events 3 • Adverse events were collected from enrollment through 24 months.
Definitions do not differ from clinicaltrials.gov definitions
|
|
General disorders
Extracardiac stimulation - LV
|
2.4%
4/164 • Number of events 5 • Adverse events were collected from enrollment through 24 months.
Definitions do not differ from clinicaltrials.gov definitions
|
|
General disorders
Dislodgment - Elevated threshold - LV
|
0.61%
1/164 • Number of events 1 • Adverse events were collected from enrollment through 24 months.
Definitions do not differ from clinicaltrials.gov definitions
|
|
Injury, poisoning and procedural complications
Pneumothorax - Procedure
|
0.61%
1/164 • Number of events 1 • Adverse events were collected from enrollment through 24 months.
Definitions do not differ from clinicaltrials.gov definitions
|
|
General disorders
Other - Lead - Procedure: difficulties due to venous access
|
0.61%
1/164 • Number of events 1 • Adverse events were collected from enrollment through 24 months.
Definitions do not differ from clinicaltrials.gov definitions
|
|
Infections and infestations
wound infection after LV lead placement
|
0.61%
1/164 • Number of events 1 • Adverse events were collected from enrollment through 24 months.
Definitions do not differ from clinicaltrials.gov definitions
|
|
Cardiac disorders
Ventricular tachycardia (VT)
|
3.0%
5/167 • Number of events 5 • Adverse events were collected from enrollment through 24 months.
Definitions do not differ from clinicaltrials.gov definitions
|
|
Cardiac disorders
Nonsustained ventricular tachycardia (NSVT)
|
1.8%
3/167 • Number of events 3 • Adverse events were collected from enrollment through 24 months.
Definitions do not differ from clinicaltrials.gov definitions
|
|
Cardiac disorders
ATRIAL TACHYARRHYTHMIAS
|
1.2%
2/167 • Number of events 2 • Adverse events were collected from enrollment through 24 months.
Definitions do not differ from clinicaltrials.gov definitions
|
|
Cardiac disorders
Atrial fibrillation (AF)
|
1.2%
2/167 • Number of events 2 • Adverse events were collected from enrollment through 24 months.
Definitions do not differ from clinicaltrials.gov definitions
|
|
Cardiac disorders
Atrial flutter
|
0.60%
1/167 • Number of events 1 • Adverse events were collected from enrollment through 24 months.
Definitions do not differ from clinicaltrials.gov definitions
|
|
Cardiac disorders
Other SVT (AVRT, AVNRT, EAT etc.)
|
0.60%
1/167 • Number of events 1 • Adverse events were collected from enrollment through 24 months.
Definitions do not differ from clinicaltrials.gov definitions
|
|
Cardiac disorders
Dyspnea - Heart failure
|
4.2%
7/167 • Number of events 8 • Adverse events were collected from enrollment through 24 months.
Definitions do not differ from clinicaltrials.gov definitions
|
|
Cardiac disorders
Peripheral edema - Heart failure
|
0.60%
1/167 • Number of events 1 • Adverse events were collected from enrollment through 24 months.
Definitions do not differ from clinicaltrials.gov definitions
|
|
Cardiac disorders
Heart failure symptoms - Unspecified
|
0.60%
1/167 • Number of events 1 • Adverse events were collected from enrollment through 24 months.
Definitions do not differ from clinicaltrials.gov definitions
|
|
Cardiac disorders
Multiple heart failure symptoms
|
1.8%
3/167 • Number of events 3 • Adverse events were collected from enrollment through 24 months.
Definitions do not differ from clinicaltrials.gov definitions
|
|
Vascular disorders
Hypotension
|
1.2%
2/167 • Number of events 2 • Adverse events were collected from enrollment through 24 months.
Definitions do not differ from clinicaltrials.gov definitions
|
|
Vascular disorders
Syncope
|
0.60%
1/167 • Number of events 3 • Adverse events were collected from enrollment through 24 months.
Definitions do not differ from clinicaltrials.gov definitions
|
|
General disorders
Dizziness
|
1.2%
2/167 • Number of events 2 • Adverse events were collected from enrollment through 24 months.
Definitions do not differ from clinicaltrials.gov definitions
|
|
Respiratory, thoracic and mediastinal disorders
Chest pain - Other
|
1.8%
3/167 • Number of events 3 • Adverse events were collected from enrollment through 24 months.
Definitions do not differ from clinicaltrials.gov definitions
|
|
Cardiac disorders
Palpitations
|
0.60%
1/167 • Number of events 1 • Adverse events were collected from enrollment through 24 months.
Definitions do not differ from clinicaltrials.gov definitions
|
|
Vascular disorders
Deep vein thrombosis (DVT)
|
0.60%
1/167 • Number of events 1 • Adverse events were collected from enrollment through 24 months.
Definitions do not differ from clinicaltrials.gov definitions
|
|
Infections and infestations
Localized infection
|
0.60%
1/167 • Number of events 1 • Adverse events were collected from enrollment through 24 months.
Definitions do not differ from clinicaltrials.gov definitions
|
|
Injury, poisoning and procedural complications
Physical trauma
|
4.2%
7/167 • Number of events 7 • Adverse events were collected from enrollment through 24 months.
Definitions do not differ from clinicaltrials.gov definitions
|
|
Blood and lymphatic system disorders
Hematological
|
0.60%
1/167 • Number of events 1 • Adverse events were collected from enrollment through 24 months.
Definitions do not differ from clinicaltrials.gov definitions
|
|
Nervous system disorders
Neurological
|
0.60%
1/167 • Number of events 1 • Adverse events were collected from enrollment through 24 months.
Definitions do not differ from clinicaltrials.gov definitions
|
|
Gastrointestinal disorders
Gastrointestinal
|
1.2%
2/167 • Number of events 2 • Adverse events were collected from enrollment through 24 months.
Definitions do not differ from clinicaltrials.gov definitions
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary
|
3.6%
6/167 • Number of events 6 • Adverse events were collected from enrollment through 24 months.
Definitions do not differ from clinicaltrials.gov definitions
|
|
Renal and urinary disorders
Genitourinary
|
3.0%
5/167 • Number of events 5 • Adverse events were collected from enrollment through 24 months.
Definitions do not differ from clinicaltrials.gov definitions
|
|
Renal and urinary disorders
Renal
|
0.60%
1/167 • Number of events 1 • Adverse events were collected from enrollment through 24 months.
Definitions do not differ from clinicaltrials.gov definitions
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal
|
3.0%
5/167 • Number of events 6 • Adverse events were collected from enrollment through 24 months.
Definitions do not differ from clinicaltrials.gov definitions
|
|
Psychiatric disorders
Psychological
|
1.8%
3/167 • Number of events 3 • Adverse events were collected from enrollment through 24 months.
Definitions do not differ from clinicaltrials.gov definitions
|
|
Skin and subcutaneous tissue disorders
Integumentary
|
1.8%
3/167 • Number of events 3 • Adverse events were collected from enrollment through 24 months.
Definitions do not differ from clinicaltrials.gov definitions
|
|
Infections and infestations
Head, eyes, ears, nose, throat (HEENT)
|
1.2%
2/167 • Number of events 2 • Adverse events were collected from enrollment through 24 months.
Definitions do not differ from clinicaltrials.gov definitions
|
|
Endocrine disorders
Endocrine
|
2.4%
4/167 • Number of events 4 • Adverse events were collected from enrollment through 24 months.
Definitions do not differ from clinicaltrials.gov definitions
|
|
Immune system disorders
Immune
|
0.60%
1/167 • Number of events 1 • Adverse events were collected from enrollment through 24 months.
Definitions do not differ from clinicaltrials.gov definitions
|
|
Blood and lymphatic system disorders
Cancer
|
0.60%
1/167 • Number of events 1 • Adverse events were collected from enrollment through 24 months.
Definitions do not differ from clinicaltrials.gov definitions
|
|
General disorders
Adverse drug reaction
|
1.8%
3/167 • Number of events 3 • Adverse events were collected from enrollment through 24 months.
Definitions do not differ from clinicaltrials.gov definitions
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place