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 range70 Years
SexALL
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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%
✓. Stable condition on Optimal Medical Therapy
✓. Able and willing to provide informed consent to participate in this study
Exclusion criteria
What they're measuring
1
Mortality
Timeframe: Through study completion, starting from consent/baseline: average of 31 months.