Status:
RECRUITING
Comparative Effectiveness of Prophylactic ICD Versus Non-ICD Therapy
Lead Sponsor:
University of Rochester
Collaborating Sponsors:
Patient-Centered Outcomes Research Institute
Conditions:
Heart Failure With Reduced Ejection Fraction
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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).
Detailed Description
The proposed CONTEMP-ICD trial is a prospective, multicenter, open-label, randomized controlled trial; enrolling 3290 participants with HFrEF, on stable and optimal guideline-directed medical therapy ...
Eligibility Criteria
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
- 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
Key Trial Info
Start Date :
March 4 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 28 2031
Estimated Enrollment :
3290 Patients enrolled
Trial Details
Trial ID
NCT06543446
Start Date
March 4 2025
End Date
February 28 2031
Last Update
January 9 2026
Active Locations (15)
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1
MaineHealth
Portland, Maine, United States, 04102
2
Johns Hopkins University
Baltimore, Maryland, United States, 21287
3
Tufts Medical Center
Boston, Massachusetts, United States, 02111
4
Corewell Health
Grand Rapids, Michigan, United States, 49503