Comparative Effectiveness of Prophylactic ICD Versus Non-ICD Therapy
Megadott ok: Low enrollment during the feasibility phase
Key facts
- Where
- Baltimore, Boston, Charlottesville, Grand Rapids, Minneapolis, Morgantown, New Brunswick, New York, Paramus, Portland, Poughkeepsie, Rochester és Salt Lake City, Egyesült ÁllamokSee the 13 sites
Where in Egyesült Államok
- Johns Hopkins UniversityBaltimore, Egyesült ÁllamokNo longer taking part
- Tufts Medical CenterBoston, Egyesült ÁllamokNo longer taking part
- University of Virginia Health SystemCharlottesville, Egyesült ÁllamokNo longer taking part
- Corewell HealthGrand Rapids, Egyesült ÁllamokNo longer taking part
- Minneapolis Heart Institute FoundationMinneapolis, Egyesült ÁllamokNo longer taking part
- West Virginia UniversityMorgantown, Egyesült ÁllamokNo longer taking part
- RutgersNew Brunswick, Egyesült ÁllamokNo longer taking part
- Northwell HealthNew York, Egyesült ÁllamokNo longer taking part
- The Valley HospitalParamus, Egyesült ÁllamokNo longer taking part
- MaineHealthPortland, Egyesült ÁllamokNo longer taking part
- Nuvance Health Hudson Valley Cardiovascular Practice, PCPoughkeepsie, Egyesült ÁllamokNo longer taking part
- University of RochesterRochester, Egyesült ÁllamokNo longer taking part
- Intermountain Health Care, Inc.Salt Lake City, Egyesült ÁllamokNo longer taking part
Trial details
- Who runs it
- University of Rochester
- Trial code
- NCT06543446
- Record updated
- 2026. május 12.
- Original description
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).Read full original descriptionShow less
Comparative Effectiveness of Prophylactic ICD Versus Non-ICD Therapy in Contemporary Heart Failure Patients With a Low Risk for Arrhythmic Death
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).
Inclusion: 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: • 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; Chronic renal failure requiring hemodialysis; History of sustained VT or VF; Existing ICD/CRT-D; Acute MI within the past 3 calendar months; Coronary revascularization within the past 3 calendar months; Known genetic cause of cardiomyopathy; Life expectancy < 1 year; Unable or unwilling to follow study protocol; Inability to consent.