Trial Outcomes & Findings for Multicenter Automatic Defibrillator Implantation Trial With Subcutaneous Implantable Cardioverter Defibrillator (NCT NCT02787785)
NCT ID: NCT02787785
Last Updated: 2024-08-22
Results Overview
The original study design was event driven with the end date expected to be based on crossing the statistical boundary. The trial enrollment was stopped in 2018 due to lower than expected enrollment, all subjects enrolled at that time were followed for approximately 5 years. The outcomes will be analyzed but are no longer statistically powered for conclusions.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
40 participants
Primary outcome timeframe
Outcome measured timeframe includes all available follow-up. Median 61 (4, 71) months.
Results posted on
2024-08-22
Participant Flow
Participant milestones
| Measure |
Conventional Medical Therapy
This arm of the trial continues with their current conventional medical therapy.
|
Subcutaneous Implantable Cardioverter Defibrillator
This arm of the trial receives a subcutaneous implantable defibrillator.
Subcutaneous Implantable Cardioverter Defibrillator: The S-ICD is an entirely subcutaneous implantable cardioverter defibrillator.
|
|---|---|---|
|
Overall Study
STARTED
|
11
|
29
|
|
Overall Study
COMPLETED
|
7
|
19
|
|
Overall Study
NOT COMPLETED
|
4
|
10
|
Reasons for withdrawal
| Measure |
Conventional Medical Therapy
This arm of the trial continues with their current conventional medical therapy.
|
Subcutaneous Implantable Cardioverter Defibrillator
This arm of the trial receives a subcutaneous implantable defibrillator.
Subcutaneous Implantable Cardioverter Defibrillator: The S-ICD is an entirely subcutaneous implantable cardioverter defibrillator.
|
|---|---|---|
|
Overall Study
Death
|
3
|
4
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
5
|
Baseline Characteristics
Multicenter Automatic Defibrillator Implantation Trial With Subcutaneous Implantable Cardioverter Defibrillator
Baseline characteristics by cohort
| Measure |
Conventional Medical Therapy
n=11 Participants
This arm of the trial continued with current conventional medical therapy.
|
Subcutaneous Implantable Cardioverter Defibrillator
n=29 Participants
This arm of the trial received a subcutaneous implantable defibrillator.
Subcutaneous Implantable Cardioverter Defibrillator: The S-ICD is an entirely subcutaneous implantable cardioverter defibrillator.
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
70.3 Years
STANDARD_DEVIATION 5.0 • n=5 Participants
|
71.1 Years
STANDARD_DEVIATION 4.7 • n=7 Participants
|
70.9 Years
STANDARD_DEVIATION 4.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=5 Participants
|
22 participants
n=7 Participants
|
28 participants
n=5 Participants
|
|
Region of Enrollment
Israel
|
2 participants
n=5 Participants
|
3 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
1 participants
n=5 Participants
|
3 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
New York Heart Association Class (NYHA)
NYHA Class I
|
2 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
New York Heart Association Class (NYHA)
NYHA Class II
|
8 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
New York Heart Association Class (NYHA)
NYHA Class III
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
History of Atrial Fibrillation
|
2 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
History of Ventricular Arrhythmias
|
1 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Prior CHF Hospitalization
|
3 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Prior Coronary Artery Bypass Graft
|
6 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Prior Percutaneous Coronary Intervention
|
9 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Hypertension
|
11 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Outcome measured timeframe includes all available follow-up. Median 61 (4, 71) months.The original study design was event driven with the end date expected to be based on crossing the statistical boundary. The trial enrollment was stopped in 2018 due to lower than expected enrollment, all subjects enrolled at that time were followed for approximately 5 years. The outcomes will be analyzed but are no longer statistically powered for conclusions.
Outcome measures
| Measure |
Conventional Medical Therapy
n=11 Participants
This arm of the trial continued with current conventional medical therapy.
|
Subcutaneous Implantable Cardioverter Defibrillator
n=29 Participants
This arm of the trial received a subcutaneous implantable defibrillator.
Subcutaneous Implantable Cardioverter Defibrillator: The S-ICD is an entirely subcutaneous implantable cardioverter defibrillator.
|
|---|---|---|
|
All-Cause Mortality
|
3 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Outcome measured timeframe includes all available follow-up. Median 61 (4, 71) months.Population: Multiple sub-groups had insufficient number of patients and/or events for analyses. Therefore, interaction analyses are not provided. The secondary endpoint is limited to the following subgroups: gender, race, ethnicity, age dichotomized at 70 years, left ventricular ejection fraction (LVEF) dichotomized at 40%, duration of diabetes, presence versus absence of insulin therapy, HbA1c dichotomized at 8%, and QRS duration \> 120 milliseconds (ms).
The original study design was event driven with the end date expected to be based on crossing the statistical boundary. The trial enrollment was stopped in 2018 due to lower than expected enrollment, all subjects enrolled at that time were followed for approximately 5 years. The outcomes will be analyzed but are no longer statistically powered for conclusions.
Outcome measures
| Measure |
Conventional Medical Therapy
n=11 Participants
This arm of the trial continued with current conventional medical therapy.
|
Subcutaneous Implantable Cardioverter Defibrillator
n=29 Participants
This arm of the trial received a subcutaneous implantable defibrillator.
Subcutaneous Implantable Cardioverter Defibrillator: The S-ICD is an entirely subcutaneous implantable cardioverter defibrillator.
|
|---|---|---|
|
All-Cause Mortality in Various Subgroups
Ethnicity - Hispanic
|
0 Participants
|
1 Participants
|
|
All-Cause Mortality in Various Subgroups
Age </= 70 years
|
2 Participants
|
2 Participants
|
|
All-Cause Mortality in Various Subgroups
Men
|
3 Participants
|
2 Participants
|
|
All-Cause Mortality in Various Subgroups
Women
|
0 Participants
|
2 Participants
|
|
All-Cause Mortality in Various Subgroups
Race - White
|
3 Participants
|
3 Participants
|
|
All-Cause Mortality in Various Subgroups
Race - African American
|
0 Participants
|
1 Participants
|
|
All-Cause Mortality in Various Subgroups
Ethnicity - Non-Hispanic
|
3 Participants
|
3 Participants
|
|
All-Cause Mortality in Various Subgroups
Age > 70 years
|
1 Participants
|
2 Participants
|
|
All-Cause Mortality in Various Subgroups
LVEF </= 40%
|
1 Participants
|
3 Participants
|
|
All-Cause Mortality in Various Subgroups
LVEF > 40%
|
2 Participants
|
1 Participants
|
|
All-Cause Mortality in Various Subgroups
Insulin Therapy
|
2 Participants
|
3 Participants
|
|
All-Cause Mortality in Various Subgroups
No Insulin Therapy
|
1 Participants
|
1 Participants
|
|
All-Cause Mortality in Various Subgroups
Diabetes duration</= 2 years
|
1 Participants
|
1 Participants
|
|
All-Cause Mortality in Various Subgroups
Diabetes duration > 2 years
|
1 Participants
|
3 Participants
|
|
All-Cause Mortality in Various Subgroups
HbA1c </= 8 %
|
2 Participants
|
4 Participants
|
|
All-Cause Mortality in Various Subgroups
HbA1c > 8 %
|
0 Participants
|
0 Participants
|
|
All-Cause Mortality in Various Subgroups
QRS </= 120ms
|
2 Participants
|
3 Participants
|
|
All-Cause Mortality in Various Subgroups
QRS > 120ms
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Outcome measured timeframe includes all available follow-up. Median 61 (4, 71) months.The original study design was event driven with the end date expected to be based on crossing the statistical boundary. The trial enrollment was stopped in 2018 due to lower than expected enrollment, all subjects enrolled at that time were followed for approximately 5 years. The outcomes will be analyzed but are no longer statistically powered for conclusions.
Outcome measures
| Measure |
Conventional Medical Therapy
n=11 Participants
This arm of the trial continued with current conventional medical therapy.
|
Subcutaneous Implantable Cardioverter Defibrillator
n=29 Participants
This arm of the trial received a subcutaneous implantable defibrillator.
Subcutaneous Implantable Cardioverter Defibrillator: The S-ICD is an entirely subcutaneous implantable cardioverter defibrillator.
|
|---|---|---|
|
Sudden Death
|
1 Participants
|
1 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Outcome measured timeframe includes all available follow-up. Median 61 (4, 71) months.Pre-specific tertiary statistical analyses will be descriptive and exploratory. This describes the number of inappropriate shocks received in the study .
Outcome measures
| Measure |
Conventional Medical Therapy
n=29 Participants
This arm of the trial continued with current conventional medical therapy.
|
Subcutaneous Implantable Cardioverter Defibrillator
This arm of the trial received a subcutaneous implantable defibrillator.
Subcutaneous Implantable Cardioverter Defibrillator: The S-ICD is an entirely subcutaneous implantable cardioverter defibrillator.
|
|---|---|---|
|
S-ICD Inappropriate Shock Frequency
|
5 inappropriate shocks
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Outcome measured timeframe includes all available follow-up. Median 61 (4, 71) months.Pre-specific tertiary statistical analyses will be descriptive and exploratory. This describes the percent of participants that received an inappropriate shock.
Outcome measures
| Measure |
Conventional Medical Therapy
n=29 Participants
This arm of the trial continued with current conventional medical therapy.
|
Subcutaneous Implantable Cardioverter Defibrillator
This arm of the trial received a subcutaneous implantable defibrillator.
Subcutaneous Implantable Cardioverter Defibrillator: The S-ICD is an entirely subcutaneous implantable cardioverter defibrillator.
|
|---|---|---|
|
S-ICD Inappropriate Shock Outcomes
|
4 Participants
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Outcome measured timeframe includes all available follow-up. Median 61 (4, 71) months.Pre-specific tertiary statistical analyses will be descriptive and exploratory. This describes the number of appropriate shocks received during the study.
Outcome measures
| Measure |
Conventional Medical Therapy
n=29 Participants
This arm of the trial continued with current conventional medical therapy.
|
Subcutaneous Implantable Cardioverter Defibrillator
This arm of the trial received a subcutaneous implantable defibrillator.
Subcutaneous Implantable Cardioverter Defibrillator: The S-ICD is an entirely subcutaneous implantable cardioverter defibrillator.
|
|---|---|---|
|
S-ICD Treated Ventricular Arrhythmia Frequency
|
5 appropriate device shocks
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Outcome measured timeframe includes all available follow-up. Median 61 (4, 71) months.Pre-specific tertiary statistical analyses will be descriptive and exploratory. This describes the number of participants that received an appropriate shock.
Outcome measures
| Measure |
Conventional Medical Therapy
n=29 Participants
This arm of the trial continued with current conventional medical therapy.
|
Subcutaneous Implantable Cardioverter Defibrillator
This arm of the trial received a subcutaneous implantable defibrillator.
Subcutaneous Implantable Cardioverter Defibrillator: The S-ICD is an entirely subcutaneous implantable cardioverter defibrillator.
|
|---|---|---|
|
S-ICD Treated Ventricular Arrhythmia Outcomes
|
3 Participants
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Outcome measured timeframe includes all available follow-up. Median 61 (4, 71) months.Pre-specific tertiary statistical analyses will be descriptive and exploratory.
Outcome measures
| Measure |
Conventional Medical Therapy
n=29 Participants
This arm of the trial continued with current conventional medical therapy.
|
Subcutaneous Implantable Cardioverter Defibrillator
This arm of the trial received a subcutaneous implantable defibrillator.
Subcutaneous Implantable Cardioverter Defibrillator: The S-ICD is an entirely subcutaneous implantable cardioverter defibrillator.
|
|---|---|---|
|
S-ICD Device Complications
|
21 percentage of patients
Interval 10.1 to 41.3
|
—
|
Adverse Events
Conventional Medical Therapy
Serious events: 8 serious events
Other events: 4 other events
Deaths: 3 deaths
Subcutaneous Implantable Cardioverter Defibrillator
Serious events: 20 serious events
Other events: 17 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
Conventional Medical Therapy
n=11 participants at risk
This arm of the trial continued with current conventional medical therapy.
|
Subcutaneous Implantable Cardioverter Defibrillator
n=29 participants at risk
This arm of the trial received a subcutaneous implantable defibrillator.
Subcutaneous Implantable Cardioverter Defibrillator: The S-ICD is an entirely subcutaneous implantable cardioverter defibrillator.
|
|---|---|---|
|
Product Issues
Inappropriate tachy therapy
|
0.00%
0/11 • Adverse events were collected from randomization through to a common end date with the minimum amount of follow-up time being 5-years. The Median follow-up time for participants was 61 months.
|
3.4%
1/29 • Number of events 1 • Adverse events were collected from randomization through to a common end date with the minimum amount of follow-up time being 5-years. The Median follow-up time for participants was 61 months.
|
|
Injury, poisoning and procedural complications
Incisional/Superficial infections (</= 30 days post implant without explant)
|
0.00%
0/11 • Adverse events were collected from randomization through to a common end date with the minimum amount of follow-up time being 5-years. The Median follow-up time for participants was 61 months.
|
3.4%
1/29 • Number of events 1 • Adverse events were collected from randomization through to a common end date with the minimum amount of follow-up time being 5-years. The Median follow-up time for participants was 61 months.
|
|
Injury, poisoning and procedural complications
Hematoma - Device pocket (> 30 days post implant)
|
0.00%
0/11 • Adverse events were collected from randomization through to a common end date with the minimum amount of follow-up time being 5-years. The Median follow-up time for participants was 61 months.
|
3.4%
1/29 • Number of events 1 • Adverse events were collected from randomization through to a common end date with the minimum amount of follow-up time being 5-years. The Median follow-up time for participants was 61 months.
|
|
Product Issues
Device System Discomfort (> 30 days post implant)
|
0.00%
0/11 • Adverse events were collected from randomization through to a common end date with the minimum amount of follow-up time being 5-years. The Median follow-up time for participants was 61 months.
|
3.4%
1/29 • Number of events 1 • Adverse events were collected from randomization through to a common end date with the minimum amount of follow-up time being 5-years. The Median follow-up time for participants was 61 months.
|
|
Cardiac disorders
Atrial Fibrillation
|
0.00%
0/11 • Adverse events were collected from randomization through to a common end date with the minimum amount of follow-up time being 5-years. The Median follow-up time for participants was 61 months.
|
10.3%
3/29 • Number of events 3 • Adverse events were collected from randomization through to a common end date with the minimum amount of follow-up time being 5-years. The Median follow-up time for participants was 61 months.
|
|
Cardiac disorders
Atrial Tachycardia
|
9.1%
1/11 • Number of events 1 • Adverse events were collected from randomization through to a common end date with the minimum amount of follow-up time being 5-years. The Median follow-up time for participants was 61 months.
|
0.00%
0/29 • Adverse events were collected from randomization through to a common end date with the minimum amount of follow-up time being 5-years. The Median follow-up time for participants was 61 months.
|
|
Cardiac disorders
Dyspnea - Heart Failure
|
9.1%
1/11 • Number of events 1 • Adverse events were collected from randomization through to a common end date with the minimum amount of follow-up time being 5-years. The Median follow-up time for participants was 61 months.
|
6.9%
2/29 • Number of events 2 • Adverse events were collected from randomization through to a common end date with the minimum amount of follow-up time being 5-years. The Median follow-up time for participants was 61 months.
|
|
Cardiac disorders
Pulmonary Edema - Heart Failure
|
0.00%
0/11 • Adverse events were collected from randomization through to a common end date with the minimum amount of follow-up time being 5-years. The Median follow-up time for participants was 61 months.
|
3.4%
1/29 • Number of events 1 • Adverse events were collected from randomization through to a common end date with the minimum amount of follow-up time being 5-years. The Median follow-up time for participants was 61 months.
|
|
Cardiac disorders
Heart Failure Symptoms, unspecified
|
9.1%
1/11 • Number of events 1 • Adverse events were collected from randomization through to a common end date with the minimum amount of follow-up time being 5-years. The Median follow-up time for participants was 61 months.
|
6.9%
2/29 • Number of events 2 • Adverse events were collected from randomization through to a common end date with the minimum amount of follow-up time being 5-years. The Median follow-up time for participants was 61 months.
|
|
Cardiac disorders
Multiple Heart Failure Symptoms
|
9.1%
1/11 • Number of events 1 • Adverse events were collected from randomization through to a common end date with the minimum amount of follow-up time being 5-years. The Median follow-up time for participants was 61 months.
|
10.3%
3/29 • Number of events 4 • Adverse events were collected from randomization through to a common end date with the minimum amount of follow-up time being 5-years. The Median follow-up time for participants was 61 months.
|
|
Vascular disorders
Hypotension
|
0.00%
0/11 • Adverse events were collected from randomization through to a common end date with the minimum amount of follow-up time being 5-years. The Median follow-up time for participants was 61 months.
|
3.4%
1/29 • Number of events 1 • Adverse events were collected from randomization through to a common end date with the minimum amount of follow-up time being 5-years. The Median follow-up time for participants was 61 months.
|
|
Cardiac disorders
Cardiac Arrest
|
18.2%
2/11 • Number of events 2 • Adverse events were collected from randomization through to a common end date with the minimum amount of follow-up time being 5-years. The Median follow-up time for participants was 61 months.
|
3.4%
1/29 • Number of events 1 • Adverse events were collected from randomization through to a common end date with the minimum amount of follow-up time being 5-years. The Median follow-up time for participants was 61 months.
|
|
Cardiac disorders
Myocardial Infarction
|
9.1%
1/11 • Number of events 1 • Adverse events were collected from randomization through to a common end date with the minimum amount of follow-up time being 5-years. The Median follow-up time for participants was 61 months.
|
3.4%
1/29 • Number of events 1 • Adverse events were collected from randomization through to a common end date with the minimum amount of follow-up time being 5-years. The Median follow-up time for participants was 61 months.
|
|
Vascular disorders
Coronary Artery Disease
|
18.2%
2/11 • Number of events 3 • Adverse events were collected from randomization through to a common end date with the minimum amount of follow-up time being 5-years. The Median follow-up time for participants was 61 months.
|
17.2%
5/29 • Number of events 5 • Adverse events were collected from randomization through to a common end date with the minimum amount of follow-up time being 5-years. The Median follow-up time for participants was 61 months.
|
|
Vascular disorders
Peripheral Vascular Disease
|
18.2%
2/11 • Number of events 4 • Adverse events were collected from randomization through to a common end date with the minimum amount of follow-up time being 5-years. The Median follow-up time for participants was 61 months.
|
3.4%
1/29 • Number of events 1 • Adverse events were collected from randomization through to a common end date with the minimum amount of follow-up time being 5-years. The Median follow-up time for participants was 61 months.
|
|
Vascular disorders
Pseudoaneurysm without hematoma
|
9.1%
1/11 • Number of events 1 • Adverse events were collected from randomization through to a common end date with the minimum amount of follow-up time being 5-years. The Median follow-up time for participants was 61 months.
|
0.00%
0/29 • Adverse events were collected from randomization through to a common end date with the minimum amount of follow-up time being 5-years. The Median follow-up time for participants was 61 months.
|
|
Cardiac disorders
Aortic Stenosis
|
0.00%
0/11 • Adverse events were collected from randomization through to a common end date with the minimum amount of follow-up time being 5-years. The Median follow-up time for participants was 61 months.
|
3.4%
1/29 • Number of events 1 • Adverse events were collected from randomization through to a common end date with the minimum amount of follow-up time being 5-years. The Median follow-up time for participants was 61 months.
|
|
Cardiac disorders
Syncope
|
0.00%
0/11 • Adverse events were collected from randomization through to a common end date with the minimum amount of follow-up time being 5-years. The Median follow-up time for participants was 61 months.
|
6.9%
2/29 • Number of events 2 • Adverse events were collected from randomization through to a common end date with the minimum amount of follow-up time being 5-years. The Median follow-up time for participants was 61 months.
|
|
Cardiac disorders
Chest Pain - Ischemic
|
9.1%
1/11 • Number of events 1 • Adverse events were collected from randomization through to a common end date with the minimum amount of follow-up time being 5-years. The Median follow-up time for participants was 61 months.
|
10.3%
3/29 • Number of events 4 • Adverse events were collected from randomization through to a common end date with the minimum amount of follow-up time being 5-years. The Median follow-up time for participants was 61 months.
|
|
Cardiac disorders
Chest Pain- Other
|
0.00%
0/11 • Adverse events were collected from randomization through to a common end date with the minimum amount of follow-up time being 5-years. The Median follow-up time for participants was 61 months.
|
3.4%
1/29 • Number of events 1 • Adverse events were collected from randomization through to a common end date with the minimum amount of follow-up time being 5-years. The Median follow-up time for participants was 61 months.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
9.1%
1/11 • Number of events 1 • Adverse events were collected from randomization through to a common end date with the minimum amount of follow-up time being 5-years. The Median follow-up time for participants was 61 months.
|
0.00%
0/29 • Adverse events were collected from randomization through to a common end date with the minimum amount of follow-up time being 5-years. The Median follow-up time for participants was 61 months.
|
|
General disorders
Fatigue/Weakness
|
0.00%
0/11 • Adverse events were collected from randomization through to a common end date with the minimum amount of follow-up time being 5-years. The Median follow-up time for participants was 61 months.
|
3.4%
1/29 • Number of events 1 • Adverse events were collected from randomization through to a common end date with the minimum amount of follow-up time being 5-years. The Median follow-up time for participants was 61 months.
|
|
Cardiac disorders
Subject Condition - Cardiovascular
|
0.00%
0/11 • Adverse events were collected from randomization through to a common end date with the minimum amount of follow-up time being 5-years. The Median follow-up time for participants was 61 months.
|
3.4%
1/29 • Number of events 1 • Adverse events were collected from randomization through to a common end date with the minimum amount of follow-up time being 5-years. The Median follow-up time for participants was 61 months.
|
|
Vascular disorders
Cerebrovascular Accident (CVA) - unspecified
|
0.00%
0/11 • Adverse events were collected from randomization through to a common end date with the minimum amount of follow-up time being 5-years. The Median follow-up time for participants was 61 months.
|
3.4%
1/29 • Number of events 1 • Adverse events were collected from randomization through to a common end date with the minimum amount of follow-up time being 5-years. The Median follow-up time for participants was 61 months.
|
|
Respiratory, thoracic and mediastinal disorders
COPD Exacerbation
|
0.00%
0/11 • Adverse events were collected from randomization through to a common end date with the minimum amount of follow-up time being 5-years. The Median follow-up time for participants was 61 months.
|
3.4%
1/29 • Number of events 1 • Adverse events were collected from randomization through to a common end date with the minimum amount of follow-up time being 5-years. The Median follow-up time for participants was 61 months.
|
|
Cardiac disorders
Death, unknown cause
|
0.00%
0/11 • Adverse events were collected from randomization through to a common end date with the minimum amount of follow-up time being 5-years. The Median follow-up time for participants was 61 months.
|
3.4%
1/29 • Number of events 1 • Adverse events were collected from randomization through to a common end date with the minimum amount of follow-up time being 5-years. The Median follow-up time for participants was 61 months.
|
|
Infections and infestations
Systemic Infection
|
0.00%
0/11 • Adverse events were collected from randomization through to a common end date with the minimum amount of follow-up time being 5-years. The Median follow-up time for participants was 61 months.
|
17.2%
5/29 • Number of events 5 • Adverse events were collected from randomization through to a common end date with the minimum amount of follow-up time being 5-years. The Median follow-up time for participants was 61 months.
|
|
General disorders
Fever and or virus
|
0.00%
0/11 • Adverse events were collected from randomization through to a common end date with the minimum amount of follow-up time being 5-years. The Median follow-up time for participants was 61 months.
|
6.9%
2/29 • Number of events 2 • Adverse events were collected from randomization through to a common end date with the minimum amount of follow-up time being 5-years. The Median follow-up time for participants was 61 months.
|
|
Injury, poisoning and procedural complications
Physical Trauma
|
9.1%
1/11 • Number of events 1 • Adverse events were collected from randomization through to a common end date with the minimum amount of follow-up time being 5-years. The Median follow-up time for participants was 61 months.
|
0.00%
0/29 • Adverse events were collected from randomization through to a common end date with the minimum amount of follow-up time being 5-years. The Median follow-up time for participants was 61 months.
|
|
Infections and infestations
Localized Infection
|
9.1%
1/11 • Number of events 1 • Adverse events were collected from randomization through to a common end date with the minimum amount of follow-up time being 5-years. The Median follow-up time for participants was 61 months.
|
6.9%
2/29 • Number of events 2 • Adverse events were collected from randomization through to a common end date with the minimum amount of follow-up time being 5-years. The Median follow-up time for participants was 61 months.
|
|
Blood and lymphatic system disorders
Hematological
|
0.00%
0/11 • Adverse events were collected from randomization through to a common end date with the minimum amount of follow-up time being 5-years. The Median follow-up time for participants was 61 months.
|
6.9%
2/29 • Number of events 2 • Adverse events were collected from randomization through to a common end date with the minimum amount of follow-up time being 5-years. The Median follow-up time for participants was 61 months.
|
|
Nervous system disorders
Neurological
|
9.1%
1/11 • Number of events 1 • Adverse events were collected from randomization through to a common end date with the minimum amount of follow-up time being 5-years. The Median follow-up time for participants was 61 months.
|
0.00%
0/29 • Adverse events were collected from randomization through to a common end date with the minimum amount of follow-up time being 5-years. The Median follow-up time for participants was 61 months.
|
|
Gastrointestinal disorders
Gastrointestinal
|
18.2%
2/11 • Number of events 2 • Adverse events were collected from randomization through to a common end date with the minimum amount of follow-up time being 5-years. The Median follow-up time for participants was 61 months.
|
10.3%
3/29 • Number of events 3 • Adverse events were collected from randomization through to a common end date with the minimum amount of follow-up time being 5-years. The Median follow-up time for participants was 61 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary
|
0.00%
0/11 • Adverse events were collected from randomization through to a common end date with the minimum amount of follow-up time being 5-years. The Median follow-up time for participants was 61 months.
|
17.2%
5/29 • Number of events 8 • Adverse events were collected from randomization through to a common end date with the minimum amount of follow-up time being 5-years. The Median follow-up time for participants was 61 months.
|
|
Renal and urinary disorders
Genitourinary
|
9.1%
1/11 • Number of events 1 • Adverse events were collected from randomization through to a common end date with the minimum amount of follow-up time being 5-years. The Median follow-up time for participants was 61 months.
|
3.4%
1/29 • Number of events 1 • Adverse events were collected from randomization through to a common end date with the minimum amount of follow-up time being 5-years. The Median follow-up time for participants was 61 months.
|
|
Renal and urinary disorders
Renal
|
0.00%
0/11 • Adverse events were collected from randomization through to a common end date with the minimum amount of follow-up time being 5-years. The Median follow-up time for participants was 61 months.
|
6.9%
2/29 • Number of events 2 • Adverse events were collected from randomization through to a common end date with the minimum amount of follow-up time being 5-years. The Median follow-up time for participants was 61 months.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal
|
9.1%
1/11 • Number of events 2 • Adverse events were collected from randomization through to a common end date with the minimum amount of follow-up time being 5-years. The Median follow-up time for participants was 61 months.
|
0.00%
0/29 • Adverse events were collected from randomization through to a common end date with the minimum amount of follow-up time being 5-years. The Median follow-up time for participants was 61 months.
|
|
Endocrine disorders
Endocrine
|
0.00%
0/11 • Adverse events were collected from randomization through to a common end date with the minimum amount of follow-up time being 5-years. The Median follow-up time for participants was 61 months.
|
3.4%
1/29 • Number of events 2 • Adverse events were collected from randomization through to a common end date with the minimum amount of follow-up time being 5-years. The Median follow-up time for participants was 61 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer
|
9.1%
1/11 • Number of events 1 • Adverse events were collected from randomization through to a common end date with the minimum amount of follow-up time being 5-years. The Median follow-up time for participants was 61 months.
|
6.9%
2/29 • Number of events 7 • Adverse events were collected from randomization through to a common end date with the minimum amount of follow-up time being 5-years. The Median follow-up time for participants was 61 months.
|
Other adverse events
| Measure |
Conventional Medical Therapy
n=11 participants at risk
This arm of the trial continued with current conventional medical therapy.
|
Subcutaneous Implantable Cardioverter Defibrillator
n=29 participants at risk
This arm of the trial received a subcutaneous implantable defibrillator.
Subcutaneous Implantable Cardioverter Defibrillator: The S-ICD is an entirely subcutaneous implantable cardioverter defibrillator.
|
|---|---|---|
|
Product Issues
Inappropriate tachy therapy, noise
|
0.00%
0/11 • Adverse events were collected from randomization through to a common end date with the minimum amount of follow-up time being 5-years. The Median follow-up time for participants was 61 months.
|
10.3%
3/29 • Number of events 3 • Adverse events were collected from randomization through to a common end date with the minimum amount of follow-up time being 5-years. The Median follow-up time for participants was 61 months.
|
|
Product Issues
Inappropriate therapy - SVT discrimination error - System
|
0.00%
0/11 • Adverse events were collected from randomization through to a common end date with the minimum amount of follow-up time being 5-years. The Median follow-up time for participants was 61 months.
|
6.9%
2/29 • Number of events 3 • Adverse events were collected from randomization through to a common end date with the minimum amount of follow-up time being 5-years. The Median follow-up time for participants was 61 months.
|
|
Injury, poisoning and procedural complications
Inadvertent Arrhythmia - Procedure
|
0.00%
0/11 • Adverse events were collected from randomization through to a common end date with the minimum amount of follow-up time being 5-years. The Median follow-up time for participants was 61 months.
|
6.9%
2/29 • Number of events 2 • Adverse events were collected from randomization through to a common end date with the minimum amount of follow-up time being 5-years. The Median follow-up time for participants was 61 months.
|
|
Cardiac disorders
Atrial Fibrillation
|
9.1%
1/11 • Number of events 1 • Adverse events were collected from randomization through to a common end date with the minimum amount of follow-up time being 5-years. The Median follow-up time for participants was 61 months.
|
6.9%
2/29 • Number of events 2 • Adverse events were collected from randomization through to a common end date with the minimum amount of follow-up time being 5-years. The Median follow-up time for participants was 61 months.
|
|
General disorders
Chest Pain - other
|
18.2%
2/11 • Number of events 2 • Adverse events were collected from randomization through to a common end date with the minimum amount of follow-up time being 5-years. The Median follow-up time for participants was 61 months.
|
3.4%
1/29 • Number of events 2 • Adverse events were collected from randomization through to a common end date with the minimum amount of follow-up time being 5-years. The Median follow-up time for participants was 61 months.
|
|
Injury, poisoning and procedural complications
Physican Trauma
|
9.1%
1/11 • Number of events 1 • Adverse events were collected from randomization through to a common end date with the minimum amount of follow-up time being 5-years. The Median follow-up time for participants was 61 months.
|
6.9%
2/29 • Number of events 2 • Adverse events were collected from randomization through to a common end date with the minimum amount of follow-up time being 5-years. The Median follow-up time for participants was 61 months.
|
|
Nervous system disorders
Neurological
|
18.2%
2/11 • Number of events 2 • Adverse events were collected from randomization through to a common end date with the minimum amount of follow-up time being 5-years. The Median follow-up time for participants was 61 months.
|
3.4%
1/29 • Number of events 1 • Adverse events were collected from randomization through to a common end date with the minimum amount of follow-up time being 5-years. The Median follow-up time for participants was 61 months.
|
|
Gastrointestinal disorders
Gastrointestinal
|
0.00%
0/11 • Adverse events were collected from randomization through to a common end date with the minimum amount of follow-up time being 5-years. The Median follow-up time for participants was 61 months.
|
6.9%
2/29 • Number of events 2 • Adverse events were collected from randomization through to a common end date with the minimum amount of follow-up time being 5-years. The Median follow-up time for participants was 61 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary
|
0.00%
0/11 • Adverse events were collected from randomization through to a common end date with the minimum amount of follow-up time being 5-years. The Median follow-up time for participants was 61 months.
|
6.9%
2/29 • Number of events 2 • Adverse events were collected from randomization through to a common end date with the minimum amount of follow-up time being 5-years. The Median follow-up time for participants was 61 months.
|
Additional Information
Clinical Trial Manager or Director of Clinical Trials (Cardiology Rhythm Management)
Boston Scientific
Phone: 1-800-227-3422
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place