Trial Outcomes & Findings for Efficacy and Safety of Implantable Cardioverter-Defibrillator (ICD) Implantation in the Elderly (NCT NCT02121158)
NCT ID: NCT02121158
Last Updated: 2024-07-31
Results Overview
All-cause mortality
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
167 participants
Primary outcome timeframe
Through study completion, starting from consent/baseline: average of 31 months.
Results posted on
2024-07-31
Participant Flow
Recruitment at six Department of Veterans Affairs Medical Centers (VAMCs). Recruitment start: 8/6/2015 (4) 9/25/2015 (1) and 10/29/2015 (1). Recruitment terminated: 12/6/2016 (1) and 12/5/2019 (5).
None: Study design did not include significant events that occur after participant enrollment: no run-in phase, nor wash-out.
Participant milestones
| Measure |
Optimal Medical Therapy
Guidance on lifestyle modification, exercise training, and disease management including review of American Heart Association (AHA) Guidelines for Primary Prevention of Cardiovascular Disease and Stroke.
|
Optimal Medical Therapy + Implantable Cardioverter Defibrillator (OMT + ICD)
Guidance on lifestyle modification, exercise training, and disease management including review of American Heart Association (AHA) Guidelines for Primary Prevention of Cardiovascular Disease and Stroke + FDA-Approved implantable cardioverter defibrillator and leads.
|
|---|---|---|
|
Overall Study
STARTED
|
85
|
82
|
|
Overall Study
COMPLETED
|
85
|
82
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy and Safety of Implantable Cardioverter-Defibrillator (ICD) Implantation in the Elderly
Baseline characteristics by cohort
| Measure |
Optimal Medical Therapy
n=85 Participants
Guidance on lifestyle modification, exercise training, and disease management including review of American Heart Association (AHA) Guidelines for Primary Prevention of Cardiovascular Disease and Stroke.
|
Optimal Medical Therapy + Implantable Cardioverter Defibrillator (OMT + ICD)
n=82 Participants
Guidance on lifestyle modification, exercise training, and disease management including review of American Heart Association (AHA) Guidelines for Primary Prevention of Cardiovascular Disease and Stroke + FDA-Approved implantable cardioverter defibrillator and leads.
|
Total
n=167 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
85 Participants
n=5 Participants
|
82 Participants
n=7 Participants
|
167 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
84 Participants
n=5 Participants
|
81 Participants
n=7 Participants
|
165 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
|
12 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
73 Participants
n=5 Participants
|
67 Participants
n=7 Participants
|
140 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
85 Participants
n=5 Participants
|
82 Participants
n=7 Participants
|
167 Participants
n=5 Participants
|
|
New York Heart Association Class: I
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
New York Heart Association Class: II
|
62 Participants
n=5 Participants
|
58 Participants
n=7 Participants
|
120 Participants
n=5 Participants
|
|
New York Heart Association Class: III
|
21 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
New York Heart Association Class: IV
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Through study completion, starting from consent/baseline: average of 31 months.All-cause mortality
Outcome measures
| Measure |
Optimal Medical Therapy
n=85 Participants
Guidance on lifestyle modification, exercise training, and disease management including review of American Heart Association (AHA) Guidelines for Primary Prevention of Cardiovascular Disease and Stroke.
|
Optimal Medical Therapy + Implantable Cardioverter Defibrillator (OMT + ICD)
n=82 Participants
Guidance on lifestyle modification, exercise training, and disease management including review of American Heart Association (AHA) Guidelines for Primary Prevention of Cardiovascular Disease and Stroke + FDA-Approved implantable cardioverter defibrillator and leads.
|
|---|---|---|
|
Mortality
|
23 Participants
|
20 Participants
|
SECONDARY outcome
Timeframe: Measured at 12-months post-randomizationPopulation: Analysis population differs from total number of study participants due to non-completion of the 12-month study visit, explained by either patient expiry or missed visit.
Minnesota Living with Heart Failure questionnaire. MLHF scoring: 0 points = Best QOL, 105 points = Worst QOL.
Outcome measures
| Measure |
Optimal Medical Therapy
n=62 Participants
Guidance on lifestyle modification, exercise training, and disease management including review of American Heart Association (AHA) Guidelines for Primary Prevention of Cardiovascular Disease and Stroke.
|
Optimal Medical Therapy + Implantable Cardioverter Defibrillator (OMT + ICD)
n=63 Participants
Guidance on lifestyle modification, exercise training, and disease management including review of American Heart Association (AHA) Guidelines for Primary Prevention of Cardiovascular Disease and Stroke + FDA-Approved implantable cardioverter defibrillator and leads.
|
|---|---|---|
|
Quality of Life - Minnesota Living With Heart Failure Questionnaire
|
11 score on a scale
Interval 6.0 to 26.5
|
13 score on a scale
Interval 5.0 to 37.0
|
SECONDARY outcome
Timeframe: Through study completion, starting from consent/baseline: average of 31 months.Sudden Cardiac Death
Outcome measures
| Measure |
Optimal Medical Therapy
n=85 Participants
Guidance on lifestyle modification, exercise training, and disease management including review of American Heart Association (AHA) Guidelines for Primary Prevention of Cardiovascular Disease and Stroke.
|
Optimal Medical Therapy + Implantable Cardioverter Defibrillator (OMT + ICD)
n=82 Participants
Guidance on lifestyle modification, exercise training, and disease management including review of American Heart Association (AHA) Guidelines for Primary Prevention of Cardiovascular Disease and Stroke + FDA-Approved implantable cardioverter defibrillator and leads.
|
|---|---|---|
|
Sudden Cardiac Death
|
5 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Through study completion, starting from consent/baseline: average of 31 months.Number of participants hospitalized during study follow-up
Outcome measures
| Measure |
Optimal Medical Therapy
n=85 Participants
Guidance on lifestyle modification, exercise training, and disease management including review of American Heart Association (AHA) Guidelines for Primary Prevention of Cardiovascular Disease and Stroke.
|
Optimal Medical Therapy + Implantable Cardioverter Defibrillator (OMT + ICD)
n=82 Participants
Guidance on lifestyle modification, exercise training, and disease management including review of American Heart Association (AHA) Guidelines for Primary Prevention of Cardiovascular Disease and Stroke + FDA-Approved implantable cardioverter defibrillator and leads.
|
|---|---|---|
|
All-cause Hospitalization
|
61 Participants
|
60 Participants
|
Adverse Events
Optimal Medical Therapy
Serious events: 67 serious events
Other events: 1 other events
Deaths: 23 deaths
Optimal Medical Therapy + Implantable Cardioverter Defibrillator (OMT + ICD)
Serious events: 62 serious events
Other events: 6 other events
Deaths: 20 deaths
Serious adverse events
| Measure |
Optimal Medical Therapy
n=85 participants at risk
Guidance on lifestyle modification, exercise training, and disease management including review of American Heart Association (AHA) Guidelines for Primary Prevention of Cardiovascular Disease and Stroke.
|
Optimal Medical Therapy + Implantable Cardioverter Defibrillator (OMT + ICD)
n=82 participants at risk
Guidance on lifestyle modification, exercise training, and disease management including review of American Heart Association (AHA) Guidelines for Primary Prevention of Cardiovascular Disease and Stroke + FDA-Approved implantable cardioverter defibrillator and leads.
|
|---|---|---|
|
Metabolism and nutrition disorders
Bleeding
|
0.00%
0/85 • Serious Adverse Events were monitored from consent/baseline through 30 days after study exit, an average of 31 months. Non-Serious Adverse Events were monitored from consent/baseline through 30 days (30 days only, i.e. 30 days past consent [OMT arm] or 30 days past implantation [ICD arm]), i.e. 30 days for all participants.
|
1.2%
1/82 • Serious Adverse Events were monitored from consent/baseline through 30 days after study exit, an average of 31 months. Non-Serious Adverse Events were monitored from consent/baseline through 30 days (30 days only, i.e. 30 days past consent [OMT arm] or 30 days past implantation [ICD arm]), i.e. 30 days for all participants.
|
|
Infections and infestations
Infection (ICD)
|
1.2%
1/85 • Serious Adverse Events were monitored from consent/baseline through 30 days after study exit, an average of 31 months. Non-Serious Adverse Events were monitored from consent/baseline through 30 days (30 days only, i.e. 30 days past consent [OMT arm] or 30 days past implantation [ICD arm]), i.e. 30 days for all participants.
|
0.00%
0/82 • Serious Adverse Events were monitored from consent/baseline through 30 days after study exit, an average of 31 months. Non-Serious Adverse Events were monitored from consent/baseline through 30 days (30 days only, i.e. 30 days past consent [OMT arm] or 30 days past implantation [ICD arm]), i.e. 30 days for all participants.
|
|
Infections and infestations
Infection (other)
|
30.6%
26/85 • Serious Adverse Events were monitored from consent/baseline through 30 days after study exit, an average of 31 months. Non-Serious Adverse Events were monitored from consent/baseline through 30 days (30 days only, i.e. 30 days past consent [OMT arm] or 30 days past implantation [ICD arm]), i.e. 30 days for all participants.
|
39.0%
32/82 • Serious Adverse Events were monitored from consent/baseline through 30 days after study exit, an average of 31 months. Non-Serious Adverse Events were monitored from consent/baseline through 30 days (30 days only, i.e. 30 days past consent [OMT arm] or 30 days past implantation [ICD arm]), i.e. 30 days for all participants.
|
|
Product Issues
Lead Alteration
|
1.2%
1/85 • Serious Adverse Events were monitored from consent/baseline through 30 days after study exit, an average of 31 months. Non-Serious Adverse Events were monitored from consent/baseline through 30 days (30 days only, i.e. 30 days past consent [OMT arm] or 30 days past implantation [ICD arm]), i.e. 30 days for all participants.
|
0.00%
0/82 • Serious Adverse Events were monitored from consent/baseline through 30 days after study exit, an average of 31 months. Non-Serious Adverse Events were monitored from consent/baseline through 30 days (30 days only, i.e. 30 days past consent [OMT arm] or 30 days past implantation [ICD arm]), i.e. 30 days for all participants.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/85 • Serious Adverse Events were monitored from consent/baseline through 30 days after study exit, an average of 31 months. Non-Serious Adverse Events were monitored from consent/baseline through 30 days (30 days only, i.e. 30 days past consent [OMT arm] or 30 days past implantation [ICD arm]), i.e. 30 days for all participants.
|
1.2%
1/82 • Serious Adverse Events were monitored from consent/baseline through 30 days after study exit, an average of 31 months. Non-Serious Adverse Events were monitored from consent/baseline through 30 days (30 days only, i.e. 30 days past consent [OMT arm] or 30 days past implantation [ICD arm]), i.e. 30 days for all participants.
|
|
Cardiac disorders
Myocardial Infarction
|
14.1%
12/85 • Serious Adverse Events were monitored from consent/baseline through 30 days after study exit, an average of 31 months. Non-Serious Adverse Events were monitored from consent/baseline through 30 days (30 days only, i.e. 30 days past consent [OMT arm] or 30 days past implantation [ICD arm]), i.e. 30 days for all participants.
|
9.8%
8/82 • Serious Adverse Events were monitored from consent/baseline through 30 days after study exit, an average of 31 months. Non-Serious Adverse Events were monitored from consent/baseline through 30 days (30 days only, i.e. 30 days past consent [OMT arm] or 30 days past implantation [ICD arm]), i.e. 30 days for all participants.
|
|
Cardiac disorders
Atrial fibrillation / Atrial flutter
|
10.6%
9/85 • Serious Adverse Events were monitored from consent/baseline through 30 days after study exit, an average of 31 months. Non-Serious Adverse Events were monitored from consent/baseline through 30 days (30 days only, i.e. 30 days past consent [OMT arm] or 30 days past implantation [ICD arm]), i.e. 30 days for all participants.
|
2.4%
2/82 • Serious Adverse Events were monitored from consent/baseline through 30 days after study exit, an average of 31 months. Non-Serious Adverse Events were monitored from consent/baseline through 30 days (30 days only, i.e. 30 days past consent [OMT arm] or 30 days past implantation [ICD arm]), i.e. 30 days for all participants.
|
|
Nervous system disorders
Stroke
|
2.4%
2/85 • Serious Adverse Events were monitored from consent/baseline through 30 days after study exit, an average of 31 months. Non-Serious Adverse Events were monitored from consent/baseline through 30 days (30 days only, i.e. 30 days past consent [OMT arm] or 30 days past implantation [ICD arm]), i.e. 30 days for all participants.
|
3.7%
3/82 • Serious Adverse Events were monitored from consent/baseline through 30 days after study exit, an average of 31 months. Non-Serious Adverse Events were monitored from consent/baseline through 30 days (30 days only, i.e. 30 days past consent [OMT arm] or 30 days past implantation [ICD arm]), i.e. 30 days for all participants.
|
|
Cardiac disorders
HF Complication
|
67.1%
57/85 • Serious Adverse Events were monitored from consent/baseline through 30 days after study exit, an average of 31 months. Non-Serious Adverse Events were monitored from consent/baseline through 30 days (30 days only, i.e. 30 days past consent [OMT arm] or 30 days past implantation [ICD arm]), i.e. 30 days for all participants.
|
65.9%
54/82 • Serious Adverse Events were monitored from consent/baseline through 30 days after study exit, an average of 31 months. Non-Serious Adverse Events were monitored from consent/baseline through 30 days (30 days only, i.e. 30 days past consent [OMT arm] or 30 days past implantation [ICD arm]), i.e. 30 days for all participants.
|
Other adverse events
| Measure |
Optimal Medical Therapy
n=85 participants at risk
Guidance on lifestyle modification, exercise training, and disease management including review of American Heart Association (AHA) Guidelines for Primary Prevention of Cardiovascular Disease and Stroke.
|
Optimal Medical Therapy + Implantable Cardioverter Defibrillator (OMT + ICD)
n=82 participants at risk
Guidance on lifestyle modification, exercise training, and disease management including review of American Heart Association (AHA) Guidelines for Primary Prevention of Cardiovascular Disease and Stroke + FDA-Approved implantable cardioverter defibrillator and leads.
|
|---|---|---|
|
General disorders
Painful implant site
|
0.00%
0/85 • Serious Adverse Events were monitored from consent/baseline through 30 days after study exit, an average of 31 months. Non-Serious Adverse Events were monitored from consent/baseline through 30 days (30 days only, i.e. 30 days past consent [OMT arm] or 30 days past implantation [ICD arm]), i.e. 30 days for all participants.
|
7.3%
6/82 • Serious Adverse Events were monitored from consent/baseline through 30 days after study exit, an average of 31 months. Non-Serious Adverse Events were monitored from consent/baseline through 30 days (30 days only, i.e. 30 days past consent [OMT arm] or 30 days past implantation [ICD arm]), i.e. 30 days for all participants.
|
|
Nervous system disorders
New dizziness
|
1.2%
1/85 • Serious Adverse Events were monitored from consent/baseline through 30 days after study exit, an average of 31 months. Non-Serious Adverse Events were monitored from consent/baseline through 30 days (30 days only, i.e. 30 days past consent [OMT arm] or 30 days past implantation [ICD arm]), i.e. 30 days for all participants.
|
0.00%
0/82 • Serious Adverse Events were monitored from consent/baseline through 30 days after study exit, an average of 31 months. Non-Serious Adverse Events were monitored from consent/baseline through 30 days (30 days only, i.e. 30 days past consent [OMT arm] or 30 days past implantation [ICD arm]), i.e. 30 days for all participants.
|
Additional Information
Michael T. Wininger, Ph.D., Study Biostatistician
VA Cooperative Studies Program Coordinating Center, West Haven, CT
Phone: 203-932-5711
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place