Efficacy and Safety of Implantable Cardioverter-Defibrillator (ICD) Implantation in the Elderly

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 (SCD) in patients 70 years and older. In
particular, this study is designed to determine the comparative effectiveness of ICD, in
addition to optimal medical therapy (OMT), in reducing all-cause mortality, versus OMT alone;
OMT includes standard intervention for chronic heart failure patients, i.e. lifestyle
modification, disease management, adoption of healthy diet and exercise practices, etcetera.
One particularly important secondary objective is to assess treatment efficacy under the
conditions of high versus low co-morbidity burden.

Participants will be randomized (1:1 ratio) to ICD + OMT or OMT alone, and stratified by
participating site and co-morbidity level (Charlson score <3 versus 3+). Acute treatment
visits will occur as clinically indicated and per local convention; follow-up will occur 1-4
months post-randomization (all participants), and not sooner than 30 days - and not later
than 120 days post-implantation (ICD arm); regular follow-up will occur at 6 month intervals
post-randomization until study close (all participants). All follow-up will be conducted
centrally. Neither the participant nor treating clinician will be masked to treatment.

Primary Objective:

The primary objective of this study is to determine if a primary prevention strategy with ICD
implantation in addition to optimal medical therapy (OMT) is effective in reducing all-cause
mortality compared to OMT alone in patients 70 years of age and older who are eligible for
ICD therapy according to current Centers for Medicare & Medicaid Services (CMS) criteria.

Primary Hypothesis:

The primary hypothesis of this study is that implantation of an ICD plus optimal medical
therapy will reduce all-cause mortality in patients 70 years of age and older versus optimal
medical therapy alone.

Secondary Objectives:

1. One secondary objective of this study is to ascertain whether age, co-morbidity burden,
or age and burden together, are determinants in mortality outcomes in the OMT versus ICD
+ OMT group.

2. An additional secondary objective of the study is to determine the effect of ICD
implantation plus optimal medical therapy on quality of life among elderly patients
compared with optimal medical therapy alone.

Inclusion Criteria:

1. 70 years of age or older

2. Eligible for ICD implementation according to the CMS criteria for primary prevention
by one of the following conditions:

1. Documented prior MI and a measured left ventricular ejection fraction (LVEF)
<=30% (includes New York Heart Association [NYHA] class I, II, or III)

2. 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

3. Ischemic dilated cardiomyopathy (IDCM), documented prior MI, NYHA class II and
III heart failure, and measured LVEF <=35%

4. Non-ischemic dilated cardiomyopathy (NIDCM) > 3 months, NYHA Class II and III
heart failure, and measured LVEF <=35%

3. Stable condition on Optimal Medical Therapy

4. Able and willing to provide informed consent to participate in this study

Exclusion Criteria:

1. Enrolled in or planning to enroll in a conflicting trial

2. Receiving a bi-ventricular ICD device

3. New York Heart Association class IV heart failure

4. Cardiogenic shock or symptomatic hypotension while in stable baseline rhythm,

5. Coronary artery bypass graft (CABG) or percutaneous transluminal coronary angioplasty
(PTCA) within the past 3 months

6. An MI within the past 40 days

7. Clinical symptoms or findings that would make them a candidate for coronary
revascularization

8. Irreversible brain damage from pre-existing cerebral disease

9. Any disease other than cardiac disease (e.g. cancer, uremia, liver failure),
associated with a likelihood of survival less than 1 year

10. Circumstance that would prevent completion of the trial and follow-up activities,
including medical condition