Efficacy and Safety of Implantable Cardioverter-Defibrillator (ICD) Implantation in the Elderly (NCT02121158) | Clinical Trial Compass
TerminatedNot Applicable
Efficacy and Safety of Implantable Cardioverter-Defibrillator (ICD) Implantation in the Elderly
Stopped: Results of the pilot were not enough to justify the extension of the pilot. Results presented are from pilot.
United States167 participantsStarted 2015-08-07
Plain-language summary
The overall aim of this trial is to study the safety and efficacy of ICD implantation as a primary prevention strategy of sudden cardiac death in patients 70 years and older. This study will assess the many competing factors involved with ICD implantation including 1) the impact on mortality, especially in the context of a declining rate of sudden death with advanced age, 2) the tolerability of the powerful therapeutic action of the device, and 3) the impact on quality of life.
Who can participate
Age range
70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 70 years of age or older
. Eligible for ICD implementation according to the CMS criteria for primary prevention by one of the following conditions:
. Documented prior MI and a measured left ventricular ejection fraction (LVEF) \<=30% (includes New York Heart Association \[NYHA\] class I, II, or III)
. Coronary artery disease with a documented prior MI, a measured left ventricular ejection fraction \<=35%, and inducible, sustained ventricular tachycardia (VT) or ventricular fibrillation (VF) at electrophysiology (EP) study
. Ischemic dilated cardiomyopathy (IDCM), documented prior MI, NYHA class II and III heart failure, and measured LVEF \<=35%
. Non-ischemic dilated cardiomyopathy (NIDCM) \> 3 months, NYHA Class II and III heart failure, and measured LVEF \<=35%
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Mortality
Timeframe: Through study completion, starting from consent/baseline: average of 31 months.