Comparative Effectiveness of Prophylactic ICD Versus Non-ICD Therapy

Stopped early · Not applicable

Conditions studied: Heart Failure With Reduced Ejection Fraction

In brief

The investigators aim to compare the risk of mortality of Non-implantable carioverter defibrillator (ICD) vs. ICD management in patients with heart failure with reduced ejection fraction (HFrEF).

Key facts

Study ID

NCT06543446

Run by

University of Rochester

People needed

3290

Starts

2025-03-04

Expected to finish

2026-04-30

Last updated by the study team

2026-05-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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 it is running

• MaineHealth — Portland, Maine, United States
• Johns Hopkins University — Baltimore, Maryland, United States
• Tufts Medical Center — Boston, Massachusetts, United States
• Corewell Health — Grand Rapids, Michigan, United States
• Minneapolis Heart Institute Foundation — Minneapolis, Minnesota, United States
• Rutgers — New Brunswick, New Jersey, United States
• The Valley Hospital — Paramus, New Jersey, United States
• Northwell Health — New York, New York, United States
• Nuvance Health Hudson Valley Cardiovascular Practice, PC — Poughkeepsie, New York, United States
• University of Rochester — Rochester, New York, United States
• Intermountain Health Care, Inc. — Salt Lake City, Utah, United States
• University of Virginia Health System — Charlottesville, Virginia, United States
• West Virginia University — Morgantown, West Virginia, United States
• University of Calgary — Calgary, Alberta, Canada
• University of Alberta — Edmonton, Alberta, Canada

Full record on ClinicalTrials.gov

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