NCT06543446

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 3,290 (estimated)
• Sponsor: University of Rochester · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 (GDMT), who are eligible for a primary prevention ICD, but have a low predicted arrhythmic risk. Enrolled participants will be randomized in a 1:1 ratio to non-ICD vs. ICD treatment arms. The investigators hypothesize that, in participants with HFrEF who have a low predicted arrhythmic risk, non-ICD vs. ICD is non-inferior with respect to the primary endpoint of all-cause mortality and superior survival free of major cardiovascular (CV) events. This study will recruit adults 18 years of age and older with heart failure. Participants will be asked to complete questionnaires. Information from medical records will be gathered including medical history, physical exam, medications, blood work results, and imaging. Visits will be at initial, three, six months, and every six months beyond six months. For those who get an ICD device an interrogation will be collected at the visits.

Conditions

• Heart Failure With Reduced Ejection Fraction

Interventions

Type	Name	Description
PROCEDURE	ICD implantation	Surgical implant of ICD device

Timeline

• Start date: 2025-03-04
• Primary completion: 2030-08-31
• Completion: 2031-02-28
• First posted: 2024-08-09
• Last updated: 2026-01-09

Locations

15 sites across 2 countries: United States, Canada