Trial Outcomes & Findings for Septal - Success Rate and Clinical Outcome of Septal Implant of Ventricular Defibrillation Lead (NCT NCT00180297)
NCT ID: NCT00180297
Last Updated: 2021-10-14
Results Overview
Success of implant procedure: 1. implanted at the randomized site; 2. With electric criteria satisfied: pacing threshold \< 1.5V, intrinsic amplitude \>3 mV, impedance between 450 and 1800 Ω, shock impedance between 29 and 80 Ω and defibrillation at a maximum of 21J.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
215 participants
Primary outcome timeframe
At implant
Results posted on
2021-10-14
Participant Flow
Participant milestones
| Measure |
Mid Septal Site Location
RV lead is placed at mid septum.
Endotak Reliance G: Reliance G is a defibrillation lead to be placed in the right ventricle.
|
Apical Site Location
RV lead is placed in apical position
Endotak Reliance G: Reliance G is a defibrillation lead to be placed in the right ventricle.
|
|---|---|---|
|
Overall Study
STARTED
|
107
|
108
|
|
Overall Study
COMPLETED
|
61
|
67
|
|
Overall Study
NOT COMPLETED
|
46
|
41
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Septal - Success Rate and Clinical Outcome of Septal Implant of Ventricular Defibrillation Lead
Baseline characteristics by cohort
| Measure |
Mid Septal Site Location
n=107 Participants
RV lead is placed at mid septum.
Endotak Reliance G: Reliance G is a defibrillation lead to be placed in the right ventricle.
|
Apical Site Location
n=108 Participants
RV lead is placed in apical position
Endotak Reliance G: Reliance G is a defibrillation lead to be placed in the right ventricle.
|
Total
n=215 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60.3 years
STANDARD_DEVIATION 12 • n=5 Participants
|
59.1 years
STANDARD_DEVIATION 12.7 • n=7 Participants
|
59.7 years
STANDARD_DEVIATION 12.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
91 Participants
n=5 Participants
|
90 Participants
n=7 Participants
|
181 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At implantSuccess of implant procedure: 1. implanted at the randomized site; 2. With electric criteria satisfied: pacing threshold \< 1.5V, intrinsic amplitude \>3 mV, impedance between 450 and 1800 Ω, shock impedance between 29 and 80 Ω and defibrillation at a maximum of 21J.
Outcome measures
| Measure |
Mid Septal Site Location
n=107 Participants
RV lead is placed at mid septum.
Endotak Reliance G: Reliance G is a defibrillation lead to be placed in the right ventricle.
|
Apical Site Location
n=108 Participants
RV lead is placed in apical position
Endotak Reliance G: Reliance G is a defibrillation lead to be placed in the right ventricle.
|
|---|---|---|
|
Implant Success Rate at Septal Site
|
97 Participants
|
99 Participants
|
SECONDARY outcome
Timeframe: 3 months, 6 months, 12 months, 36 months, 60 monthsPopulation: The number of participants analyzed per time frame is excluding those participants that have ended the study before the time frame or for whom visit data is missing
Outcome measures
| Measure |
Mid Septal Site Location
n=91 Participants
RV lead is placed at mid septum.
Endotak Reliance G: Reliance G is a defibrillation lead to be placed in the right ventricle.
|
Apical Site Location
n=104 Participants
RV lead is placed in apical position
Endotak Reliance G: Reliance G is a defibrillation lead to be placed in the right ventricle.
|
|---|---|---|
|
- The Number of "Low Energy" Shocks (at 11 Joules), Efficient in the VT Zone, in the Population Programmed at This Recommended Value.
3 Months
|
0 Participants
|
3 Participants
|
|
- The Number of "Low Energy" Shocks (at 11 Joules), Efficient in the VT Zone, in the Population Programmed at This Recommended Value.
6 Months
|
1 Participants
|
4 Participants
|
|
- The Number of "Low Energy" Shocks (at 11 Joules), Efficient in the VT Zone, in the Population Programmed at This Recommended Value.
12 Months
|
2 Participants
|
7 Participants
|
|
- The Number of "Low Energy" Shocks (at 11 Joules), Efficient in the VT Zone, in the Population Programmed at This Recommended Value.
36 Months
|
2 Participants
|
11 Participants
|
|
- The Number of "Low Energy" Shocks (at 11 Joules), Efficient in the VT Zone, in the Population Programmed at This Recommended Value.
60 Months
|
4 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: 3 months, 6 months, 12 months, 36 months, 60 monthsPopulation: The number of participants analyzed per time frame is excluding those participants that have ended the study before the time frame or for whom visit data is missing
in VT zone with at least one efficient ATP
Outcome measures
| Measure |
Mid Septal Site Location
n=91 Participants
RV lead is placed at mid septum.
Endotak Reliance G: Reliance G is a defibrillation lead to be placed in the right ventricle.
|
Apical Site Location
n=104 Participants
RV lead is placed in apical position
Endotak Reliance G: Reliance G is a defibrillation lead to be placed in the right ventricle.
|
|---|---|---|
|
The Rate of ATP Success Therapy
3 Months
|
6 Participants
|
11 Participants
|
|
The Rate of ATP Success Therapy
6 Months
|
12 Participants
|
14 Participants
|
|
The Rate of ATP Success Therapy
12 Months
|
19 Participants
|
19 Participants
|
|
The Rate of ATP Success Therapy
36 Months
|
23 Participants
|
23 Participants
|
|
The Rate of ATP Success Therapy
60 Months
|
17 Participants
|
20 Participants
|
SECONDARY outcome
Timeframe: Discharge, 3 Months, 6 Months, 12 Months, 36 Months, 60 MonthsPopulation: The number of participants analyzed per time frame is excluding those participants that have ended the study before the time frame or for whom visit data is missing
Outcome measures
| Measure |
Mid Septal Site Location
n=107 Participants
RV lead is placed at mid septum.
Endotak Reliance G: Reliance G is a defibrillation lead to be placed in the right ventricle.
|
Apical Site Location
n=108 Participants
RV lead is placed in apical position
Endotak Reliance G: Reliance G is a defibrillation lead to be placed in the right ventricle.
|
|---|---|---|
|
Spontaneous Episodes and Therapy Delivery - at Least One Appropriate Treatment
Discharge
|
1 Participants
|
2 Participants
|
|
Spontaneous Episodes and Therapy Delivery - at Least One Appropriate Treatment
3 Months
|
8 Participants
|
11 Participants
|
|
Spontaneous Episodes and Therapy Delivery - at Least One Appropriate Treatment
6 Months
|
14 Participants
|
17 Participants
|
|
Spontaneous Episodes and Therapy Delivery - at Least One Appropriate Treatment
12 Months
|
21 Participants
|
22 Participants
|
|
Spontaneous Episodes and Therapy Delivery - at Least One Appropriate Treatment
36 Months
|
23 Participants
|
28 Participants
|
|
Spontaneous Episodes and Therapy Delivery - at Least One Appropriate Treatment
60 Months
|
19 Participants
|
23 Participants
|
SECONDARY outcome
Timeframe: Discharge, 3 Months, 6 Months, 12 Months, 36 Months, 60 MonthsPopulation: The number of participants analyzed per time frame is excluding those participants that have ended the study before the time frame or for whom visit data is missing
Outcome measures
| Measure |
Mid Septal Site Location
n=107 Participants
RV lead is placed at mid septum.
Endotak Reliance G: Reliance G is a defibrillation lead to be placed in the right ventricle.
|
Apical Site Location
n=108 Participants
RV lead is placed in apical position
Endotak Reliance G: Reliance G is a defibrillation lead to be placed in the right ventricle.
|
|---|---|---|
|
Spontaneous Episodes and Therapy Delivery - at Least One Inappropriate Treatment
Discharge
|
0 Participants
|
0 Participants
|
|
Spontaneous Episodes and Therapy Delivery - at Least One Inappropriate Treatment
3 Months
|
4 Participants
|
3 Participants
|
|
Spontaneous Episodes and Therapy Delivery - at Least One Inappropriate Treatment
6 Months
|
3 Participants
|
4 Participants
|
|
Spontaneous Episodes and Therapy Delivery - at Least One Inappropriate Treatment
12 Months
|
9 Participants
|
8 Participants
|
|
Spontaneous Episodes and Therapy Delivery - at Least One Inappropriate Treatment
36 Months
|
8 Participants
|
6 Participants
|
|
Spontaneous Episodes and Therapy Delivery - at Least One Inappropriate Treatment
60 Months
|
8 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: 12 MonthsLVEF at 12 months and the change in LVEF at 12 months compared to implant (in %)
Outcome measures
| Measure |
Mid Septal Site Location
n=82 Participants
RV lead is placed at mid septum.
Endotak Reliance G: Reliance G is a defibrillation lead to be placed in the right ventricle.
|
Apical Site Location
n=99 Participants
RV lead is placed in apical position
Endotak Reliance G: Reliance G is a defibrillation lead to be placed in the right ventricle.
|
|---|---|---|
|
Evolution of Left Ventricular Ejection Fraction
LVEF at 12 Months
|
41.96 Percentage of LVEF
Standard Deviation 13.81
|
40.57 Percentage of LVEF
Standard Deviation 14.00
|
|
Evolution of Left Ventricular Ejection Fraction
LVEF (%) Change from Implant
|
5.66 Percentage of LVEF
Standard Deviation 11.96
|
6.16 Percentage of LVEF
Standard Deviation 11.96
|
Adverse Events
Mid Septal Site Location
Serious events: 35 serious events
Other events: 17 other events
Deaths: 20 deaths
Apical Site Location
Serious events: 34 serious events
Other events: 17 other events
Deaths: 27 deaths
Serious adverse events
| Measure |
Mid Septal Site Location
n=107 participants at risk
RV lead is placed at mid septum.
Endotak Reliance G: Reliance G is a defibrillation lead to be placed in the right ventricle.
|
Apical Site Location
n=108 participants at risk
RV lead is placed in apical position
Endotak Reliance G: Reliance G is a defibrillation lead to be placed in the right ventricle.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal
|
1.9%
2/107 • Number of events 2 • 5 years after device implant
|
0.00%
0/108 • 5 years after device implant
|
|
Cardiac disorders
Ablation
|
1.9%
2/107 • Number of events 3 • 5 years after device implant
|
0.00%
0/108 • 5 years after device implant
|
|
Cardiac disorders
Atrial Fibrillation
|
0.00%
0/107 • 5 years after device implant
|
0.93%
1/108 • Number of events 1 • 5 years after device implant
|
|
Vascular disorders
Aneurysm
|
0.00%
0/107 • 5 years after device implant
|
0.93%
1/108 • Number of events 1 • 5 years after device implant
|
|
Cardiac disorders
Angina Pectoris
|
0.00%
0/107 • 5 years after device implant
|
0.93%
1/108 • Number of events 1 • 5 years after device implant
|
|
Cardiac disorders
Angioplasty
|
3.7%
4/107 • Number of events 4 • 5 years after device implant
|
0.00%
0/108 • 5 years after device implant
|
|
Vascular disorders
Aorto Femoro Bypass
|
0.00%
0/107 • 5 years after device implant
|
0.93%
1/108 • Number of events 1 • 5 years after device implant
|
|
Cardiac disorders
Arrhythmic Storm
|
4.7%
5/107 • Number of events 7 • 5 years after device implant
|
2.8%
3/108 • Number of events 3 • 5 years after device implant
|
|
Infections and infestations
Artheritis
|
0.00%
0/107 • 5 years after device implant
|
0.93%
1/108 • Number of events 1 • 5 years after device implant
|
|
Psychiatric disorders
Antivitamin K Overdose
|
0.00%
0/107 • 5 years after device implant
|
0.93%
1/108 • Number of events 1 • 5 years after device implant
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder Cancer
|
0.00%
0/107 • 5 years after device implant
|
0.93%
1/108 • Number of events 1 • 5 years after device implant
|
|
Vascular disorders
Bleeding
|
0.93%
1/107 • Number of events 1 • 5 years after device implant
|
0.00%
0/108 • 5 years after device implant
|
|
Cardiac disorders
Bypass
|
0.00%
0/107 • 5 years after device implant
|
0.93%
1/108 • Number of events 1 • 5 years after device implant
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer
|
0.00%
0/107 • 5 years after device implant
|
0.93%
1/108 • Number of events 2 • 5 years after device implant
|
|
Cardiac disorders
Cardioversion
|
1.9%
2/107 • Number of events 2 • 5 years after device implant
|
2.8%
3/108 • Number of events 3 • 5 years after device implant
|
|
Vascular disorders
Carotid
|
0.00%
0/107 • 5 years after device implant
|
0.93%
1/108 • Number of events 1 • 5 years after device implant
|
|
Hepatobiliary disorders
Cholesystectomy
|
0.93%
1/107 • Number of events 1 • 5 years after device implant
|
0.00%
0/108 • 5 years after device implant
|
|
Product Issues
Connection
|
0.93%
1/107 • Number of events 1 • 5 years after device implant
|
0.00%
0/108 • 5 years after device implant
|
|
Cardiac disorders
Cardiac Resynchronization Therapy - Defibrillator
|
0.93%
1/107 • Number of events 1 • 5 years after device implant
|
0.93%
1/108 • Number of events 1 • 5 years after device implant
|
|
Vascular disorders
Cardiovascular Accident (CVA)
|
0.00%
0/107 • 5 years after device implant
|
1.9%
2/108 • Number of events 2 • 5 years after device implant
|
|
General disorders
Dental
|
0.93%
1/107 • Number of events 1 • 5 years after device implant
|
0.00%
0/108 • 5 years after device implant
|
|
Cardiac disorders
Defibrillation thhreshold
|
0.93%
1/107 • Number of events 1 • 5 years after device implant
|
1.9%
2/108 • Number of events 2 • 5 years after device implant
|
|
Endocrine disorders
Diabetes
|
0.00%
0/107 • 5 years after device implant
|
0.93%
1/108 • Number of events 1 • 5 years after device implant
|
|
Product Issues
Dislodgement
|
1.9%
2/107 • Number of events 2 • 5 years after device implant
|
0.93%
1/108 • Number of events 1 • 5 years after device implant
|
|
Cardiac disorders
Drug
|
5.6%
6/107 • Number of events 8 • 5 years after device implant
|
4.6%
5/108 • Number of events 5 • 5 years after device implant
|
|
Cardiac disorders
Effusion
|
0.93%
1/107 • Number of events 1 • 5 years after device implant
|
0.00%
0/108 • 5 years after device implant
|
|
Product Issues
End of life
|
2.8%
3/107 • Number of events 3 • 5 years after device implant
|
3.7%
4/108 • Number of events 4 • 5 years after device implant
|
|
Cardiac disorders
Explant Intracardiac defibrillator
|
0.93%
1/107 • Number of events 1 • 5 years after device implant
|
0.00%
0/108 • 5 years after device implant
|
|
Cardiac disorders
Explant System
|
0.00%
0/107 • 5 years after device implant
|
0.93%
1/108 • Number of events 1 • 5 years after device implant
|
|
Eye disorders
Eye
|
0.00%
0/107 • 5 years after device implant
|
0.93%
1/108 • Number of events 1 • 5 years after device implant
|
|
Product Issues
Failure
|
0.93%
1/107 • Number of events 1 • 5 years after device implant
|
0.93%
1/108 • Number of events 1 • 5 years after device implant
|
|
Cardiac disorders
Ventricular Fibrillation
|
0.00%
0/107 • 5 years after device implant
|
0.93%
1/108 • Number of events 1 • 5 years after device implant
|
|
Infections and infestations
Gout
|
0.00%
0/107 • 5 years after device implant
|
0.93%
1/108 • Number of events 1 • 5 years after device implant
|
|
Cardiac disorders
Heart Transplant
|
3.7%
4/107 • Number of events 4 • 5 years after device implant
|
2.8%
3/108 • Number of events 3 • 5 years after device implant
|
|
Infections and infestations
Hematoma/Infection
|
1.9%
2/107 • Number of events 4 • 5 years after device implant
|
0.93%
1/108 • Number of events 1 • 5 years after device implant
|
|
Injury, poisoning and procedural complications
Hematoma/infection at implant
|
0.93%
1/107 • Number of events 1 • 5 years after device implant
|
1.9%
2/108 • Number of events 2 • 5 years after device implant
|
|
Cardiac disorders
heart Failure
|
4.7%
5/107 • Number of events 9 • 5 years after device implant
|
12.0%
13/108 • Number of events 16 • 5 years after device implant
|
|
Endocrine disorders
Hypoglycemie
|
0.93%
1/107 • Number of events 1 • 5 years after device implant
|
0.00%
0/108 • 5 years after device implant
|
|
Cardiac disorders
Intracardiac Defibrillator Programming
|
0.93%
1/107 • Number of events 1 • 5 years after device implant
|
0.00%
0/108 • 5 years after device implant
|
|
Infections and infestations
Infection
|
1.9%
2/107 • Number of events 2 • 5 years after device implant
|
3.7%
4/108 • Number of events 4 • 5 years after device implant
|
|
Cardiac disorders
Left Ventricular assistance
|
0.93%
1/107 • Number of events 1 • 5 years after device implant
|
0.00%
0/108 • 5 years after device implant
|
|
Cardiac disorders
Mitral Valve
|
0.93%
1/107 • Number of events 1 • 5 years after device implant
|
0.00%
0/108 • 5 years after device implant
|
|
Nervous system disorders
Neurologic
|
0.93%
1/107 • Number of events 1 • 5 years after device implant
|
1.9%
2/108 • Number of events 2 • 5 years after device implant
|
|
Musculoskeletal and connective tissue disorders
Orthopedic
|
0.00%
0/107 • 5 years after device implant
|
0.93%
1/108 • Number of events 1 • 5 years after device implant
|
|
Cardiac disorders
Orthostatic
|
0.00%
0/107 • 5 years after device implant
|
0.93%
1/108 • Number of events 1 • 5 years after device implant
|
|
Investigations
Other
|
0.93%
1/107 • Number of events 1 • 5 years after device implant
|
0.00%
0/108 • 5 years after device implant
|
|
Product Issues
Oversensing
|
0.00%
0/107 • 5 years after device implant
|
0.93%
1/108 • Number of events 1 • 5 years after device implant
|
|
Cardiac disorders
Pain
|
1.9%
2/107 • Number of events 3 • 5 years after device implant
|
0.00%
0/108 • 5 years after device implant
|
|
Cardiac disorders
Peripheral angioplasty
|
0.00%
0/107 • 5 years after device implant
|
0.93%
1/108 • Number of events 1 • 5 years after device implant
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/107 • 5 years after device implant
|
0.93%
1/108 • Number of events 1 • 5 years after device implant
|
|
Respiratory, thoracic and mediastinal disorders
Pneumopathy
|
0.00%
0/107 • 5 years after device implant
|
0.93%
1/108 • Number of events 1 • 5 years after device implant
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.93%
1/107 • Number of events 1 • 5 years after device implant
|
0.00%
0/108 • 5 years after device implant
|
|
Infections and infestations
Pocket infection
|
0.93%
1/107 • Number of events 1 • 5 years after device implant
|
0.00%
0/108 • 5 years after device implant
|
|
Surgical and medical procedures
post sternotomy
|
0.00%
0/107 • 5 years after device implant
|
0.93%
1/108 • Number of events 1 • 5 years after device implant
|
|
Cardiac disorders
Pre-transplant
|
0.00%
0/107 • 5 years after device implant
|
2.8%
3/108 • Number of events 3 • 5 years after device implant
|
|
Product Issues
premature End of Life
|
2.8%
3/107 • Number of events 3 • 5 years after device implant
|
2.8%
3/108 • Number of events 3 • 5 years after device implant
|
|
Reproductive system and breast disorders
prostate
|
0.93%
1/107 • Number of events 1 • 5 years after device implant
|
0.93%
1/108 • Number of events 1 • 5 years after device implant
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary
|
1.9%
2/107 • Number of events 4 • 5 years after device implant
|
0.00%
0/108 • 5 years after device implant
|
|
Renal and urinary disorders
renal angioplasty
|
0.00%
0/107 • 5 years after device implant
|
0.93%
1/108 • Number of events 2 • 5 years after device implant
|
|
Renal and urinary disorders
Renal insufficiency
|
0.00%
0/107 • 5 years after device implant
|
0.93%
1/108 • Number of events 1 • 5 years after device implant
|
|
Cardiac disorders
reprogramming
|
0.93%
1/107 • Number of events 1 • 5 years after device implant
|
0.00%
0/108 • 5 years after device implant
|
|
Infections and infestations
Rhumatism
|
0.00%
0/107 • 5 years after device implant
|
0.93%
1/108 • Number of events 1 • 5 years after device implant
|
|
Skin and subcutaneous tissue disorders
scar dehiscence
|
0.00%
0/107 • 5 years after device implant
|
0.93%
1/108 • Number of events 1 • 5 years after device implant
|
|
Endocrine disorders
Thyroid
|
0.93%
1/107 • Number of events 2 • 5 years after device implant
|
0.00%
0/108 • 5 years after device implant
|
|
General disorders
|
0.00%
0/107 • 5 years after device implant
|
0.93%
1/108 • Number of events 1 • 5 years after device implant
|
|
Renal and urinary disorders
urogenital
|
0.00%
0/107 • 5 years after device implant
|
0.93%
1/108 • Number of events 1 • 5 years after device implant
|
|
Nervous system disorders
Vagal syndrome
|
0.93%
1/107 • Number of events 1 • 5 years after device implant
|
0.00%
0/108 • 5 years after device implant
|
|
Cardiac disorders
Ventricular Tachycardia
|
0.93%
1/107 • Number of events 1 • 5 years after device implant
|
1.9%
2/108 • Number of events 2 • 5 years after device implant
|
Other adverse events
| Measure |
Mid Septal Site Location
n=107 participants at risk
RV lead is placed at mid septum.
Endotak Reliance G: Reliance G is a defibrillation lead to be placed in the right ventricle.
|
Apical Site Location
n=108 participants at risk
RV lead is placed in apical position
Endotak Reliance G: Reliance G is a defibrillation lead to be placed in the right ventricle.
|
|---|---|---|
|
Cardiac disorders
Atrial Fibrillation
|
0.93%
1/107 • Number of events 1 • 5 years after device implant
|
0.93%
1/108 • Number of events 1 • 5 years after device implant
|
|
Cardiac disorders
Angor
|
0.00%
0/107 • 5 years after device implant
|
0.93%
1/108 • Number of events 1 • 5 years after device implant
|
|
Cardiac disorders
Atrial Disorder
|
0.93%
1/107 • Number of events 1 • 5 years after device implant
|
0.00%
0/108 • 5 years after device implant
|
|
Product Issues
Crosstalk
|
0.93%
1/107 • Number of events 1 • 5 years after device implant
|
0.00%
0/108 • 5 years after device implant
|
|
Metabolism and nutrition disorders
diet
|
0.00%
0/107 • 5 years after device implant
|
0.93%
1/108 • Number of events 1 • 5 years after device implant
|
|
Gastrointestinal disorders
Dysphagy
|
0.93%
1/107 • Number of events 1 • 5 years after device implant
|
0.00%
0/108 • 5 years after device implant
|
|
Surgical and medical procedures
healing issue
|
0.93%
1/107 • Number of events 1 • 5 years after device implant
|
0.00%
0/108 • 5 years after device implant
|
|
Cardiac disorders
Heart Failure
|
0.00%
0/107 • 5 years after device implant
|
0.93%
1/108 • Number of events 1 • 5 years after device implant
|
|
Product Issues
Impedance > 3000
|
0.93%
1/107 • Number of events 1 • 5 years after device implant
|
0.00%
0/108 • 5 years after device implant
|
|
Injury, poisoning and procedural complications
Implant
|
1.9%
2/107 • Number of events 2 • 5 years after device implant
|
0.00%
0/108 • 5 years after device implant
|
|
Product Issues
Inappropriate Therapy
|
0.93%
1/107 • Number of events 1 • 5 years after device implant
|
1.9%
2/108 • Number of events 4 • 5 years after device implant
|
|
Product Issues
Limit algorhythm
|
1.9%
2/107 • Number of events 3 • 5 years after device implant
|
3.7%
4/108 • Number of events 4 • 5 years after device implant
|
|
Product Issues
Loss Capture
|
0.93%
1/107 • Number of events 1 • 5 years after device implant
|
0.93%
1/108 • Number of events 1 • 5 years after device implant
|
|
Nervous system disorders
Neurologic
|
0.00%
0/107 • 5 years after device implant
|
0.93%
1/108 • Number of events 2 • 5 years after device implant
|
|
Product Issues
Oversensing
|
0.00%
0/107 • 5 years after device implant
|
1.9%
2/108 • Number of events 2 • 5 years after device implant
|
|
General disorders
Pain
|
0.00%
0/107 • 5 years after device implant
|
0.93%
1/108 • Number of events 1 • 5 years after device implant
|
|
Psychiatric disorders
Psychologic
|
0.93%
1/107 • Number of events 1 • 5 years after device implant
|
0.00%
0/108 • 5 years after device implant
|
|
Product Issues
Rhythm ID
|
0.00%
0/107 • 5 years after device implant
|
0.93%
1/108 • Number of events 1 • 5 years after device implant
|
|
Cardiac disorders
Shock
|
0.93%
1/107 • Number of events 1 • 5 years after device implant
|
0.00%
0/108 • 5 years after device implant
|
|
Skin and subcutaneous tissue disorders
Site of puncture
|
0.93%
1/107 • Number of events 1 • 5 years after device implant
|
0.00%
0/108 • 5 years after device implant
|
|
Product Issues
Smart sensing
|
0.00%
0/107 • 5 years after device implant
|
0.93%
1/108 • Number of events 1 • 5 years after device implant
|
|
Injury, poisoning and procedural complications
Sternotomy wires
|
0.00%
0/107 • 5 years after device implant
|
0.93%
1/108 • Number of events 1 • 5 years after device implant
|
|
Endocrine disorders
Thyroid
|
0.93%
1/107 • Number of events 1 • 5 years after device implant
|
0.00%
0/108 • 5 years after device implant
|
|
Cardiac disorders
Tricuspid insufficiency
|
0.00%
0/107 • 5 years after device implant
|
0.93%
1/108 • Number of events 1 • 5 years after device implant
|
|
Cardiac disorders
Supraventricular Tachycardia
|
0.93%
1/107 • Number of events 1 • 5 years after device implant
|
1.9%
2/108 • Number of events 2 • 5 years after device implant
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor
|
0.00%
0/107 • 5 years after device implant
|
0.93%
1/108 • Number of events 1 • 5 years after device implant
|
|
Product Issues
Inappropriate programming
|
3.7%
4/107 • Number of events 5 • 5 years after device implant
|
2.8%
3/108 • Number of events 3 • 5 years after device implant
|
Additional Information
Elisabeth Mouton - Clinical Trial Manager
Boston Scientific
Phone: +33 1 39 30 11 90
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place