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

Heart Failure With Reduced Ejection Fraction

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

Plain Language Summary

Simplified for easier understanding

This trial compares implantable defibrillators (ICDs) to non-ICD heart failure treatments in patients who qualify for a defibrillator but may be at lower risk of sudden death. You may be eligible if... - You are 18 years or older with heart failure (ischemic or non-ischemic) and a weak heart (LVEF 35% or below, or 30% or below with mild symptoms) - You are on optimal, stable guideline-directed heart failure medications for at least one month - You qualify for a primary prevention ICD but have a lower predicted benefit score You may NOT be eligible if... - You already have an ICD or CRT-D device - You had a heart attack or heart procedure in the past 3 months - You are on kidney dialysis - You have a history of dangerous heart rhythms (sustained VT or VF) - Your life expectancy is less than 1 year Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

PROCEDUREICD implantation

Surgical implant of ICD device

Locations(15)

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

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06543446

Related Trials

Digital Remote Management Versus Usual Care for Optimization of Guideline-directed Medical Therapy in Patients With Heart Failure and Reduced Ejection Fraction: a Multicentre, Randomised, Controlled Trial (DigiCare-HFrEF)

NCT073528916 locations

Mechanistic Clinical Trial Comparing the Pharmacokinetics/Pharmacodynamics of Metoprolol in Heart Failure With Reduced Ejection Fraction Patients With Low vs. High Polygenic Score

NCT074900671 location

A Safety and Tolerability Study of HJB647 in Heart Failure Participants With Reduced Ejection Fraction

NCT074656533 locations

Synchronized Diaphragmatic Stimulation in Symptomatic Heart Failure

NCT065526371 location

Real-Time Monitoring of Heart Failure Across the Yale New Haven Health System

NCT042377011 location