RecruitingNot ApplicableNCT06543446
Comparative Effectiveness of Prophylactic ICD Versus Non-ICD Therapy
Comparative Effectiveness of Prophylactic ICD Versus Non-ICD Therapy in Contemporary Heart Failure Patients With a Low Risk for Arrhythmic Death
Sponsor
University of Rochester
Enrollment
3,290 participants
Start Date
Mar 4, 2025
Study Type
INTERVENTIONAL
Conditions
Summary
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).
Eligibility
Min Age: 18 Years
Inclusion Criteria6
- 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 Criteria10
- 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
Interventions
PROCEDUREICD implantation
Surgical implant of ICD device
Locations(15)
View Full Details on ClinicalTrials.gov
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NCT06543446
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