Comparing ICD and non-ICD treatments for heart failure patients
Comparative Effectiveness of Prophylactic ICD Versus Non-ICD Therapy in Contemporary Heart Failure Patients With a Low Risk for Arrhythmic Death
This study is testing whether using implantable defibrillators helps heart failure patients live longer and have fewer serious heart problems compared to those who don’t use them.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 3290 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Rochester Academic / other |
| Locations | 13 sites (Portland, Maine and 12 other locations) |
| Trial ID | NCT06543446 on ClinicalTrials.gov |
What this trial studies
This trial aims to evaluate the effectiveness of implantable cardioverter defibrillators (ICDs) compared to non-ICD management in patients with heart failure with reduced ejection fraction (HFrEF) who are at low risk for arrhythmias. It is a multicenter, open-label, randomized controlled trial enrolling 3,290 participants who are on stable guideline-directed medical therapy. Participants will be randomly assigned to receive either ICD treatment or non-ICD management, with the primary goal of assessing all-cause mortality and major cardiovascular events over time.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with heart failure and low predicted arrhythmic risk who meet specific criteria for ICD eligibility.
Not a fit: Patients who already have an existing ICD or those requiring other cardiac devices will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help determine whether non-ICD management is a safe and effective alternative for certain heart failure patients, potentially reducing unnecessary procedures.
How similar studies have performed: Previous studies have explored ICD effectiveness, but this specific comparison in low-risk HFrEF patients is a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥ 18 years (no upper limit) * Class I or IIa indication for a primary prevention ICD15: Ischemic or non-ischemic cardiomyopathy and NYHA Class ≥ II if most recent LVEF is ≤ 35% OR ischemic cardiomyopathy with NYHA Class I if most recent LVEF is ≤ 30% * Most recent LVEF (%) obtained per cardiac imaging obtained at any time prior to enrollment after being stable on optimal GDMT\*\* for at least one month * Stable optimal GDMT at least one calendar month prior to last cardiac imaging test, prespecified as one of the following for at least 1 calendar month prior to study randomization: receiving all 4 therapy classes (beta-blockers, ARNI/ARB/ACE, MRA and SGLT2i) OR GDMT Score ≥ 6 (per Figure 7) • MADIT-ICD Benefit Score \< 50 (per Figure 4) Exclusion Criteria: * Existing ICD/CRT-D * • Planned CRT-P or CRT-D implant for any indications including Class I or IIa indication for CRT: Presence of left bundle branch block (LBBB) with QRS ≥ 120 msec OR QRS duration ≥ 150 msec regardless of QRS morphology OR decision for CRT implant by EP provider for other indications * Acute MI within the past 3 calendar months * Chronic renal failure requiring hemodialysis * Coronary revascularization within the past 3 calendar months * History of sustained VT or VF * Known genetic cause of cardiomyopathy * Life expectancy \< 1 year * Unable or unwilling to follow study protocol * Inability to consent
Where this trial is running
Portland, Maine and 12 other locations
- MaineHealth — Portland, Maine, United States (Recruiting)
- Corewell Health — Grand Rapids, Michigan, United States (Recruiting)
- Minneapolis Heart Institute Foundation — Minneapolis, Minnesota, United States (Recruiting)
- Rutgers — New Brunswick, New Jersey, United States (Recruiting)
- The Valley Hospital — Paramus, New Jersey, United States (Recruiting)
- Northwell Health — New York, New York, United States (Recruiting)
- Nuvance Health Hudson Valley Cardiovascular Practice, PC — Poughkeepsie, New York, United States (Recruiting)
- University of Rochester — Rochester, New York, United States (Recruiting)
- Intermountain Health Care, Inc. — Salt Lake City, Utah, United States (Recruiting)
- University of Virginia Health System — Charlottesville, Virginia, United States (Recruiting)
- West Virginia University — Morgantown, West Virginia, United States (Recruiting)
- University of Calgary — Calgary, Alberta, Canada (Recruiting)
- University of Alberta — Edmonton, Alberta, Canada (Recruiting)
Study contacts
- Principal investigator: Ilan Goldenberg, MD — Univ of Rochester Medical Center, Clinical Cardiovascular Research Center
- Study coordinator: Ilan Goldenberg
- Email: ilan.goldenberg@heart.rochester.edu
- Phone: 585-275-5391
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.