Comparative Effectiveness of Prophylactic ICD Versus Non-ICD Therapy (CONTEMP-ICD)

May 7, 2026 updated by: Ilan Goldenberg, University of Rochester

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).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

3290

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N4Z6
        • University of Calgary
      • Edmonton, Alberta, Canada, T6G 2B7
        • University of Alberta
  • United States
    • Maine
      • Portland, Maine, United States, 04102
        • MaineHealth
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins University
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • Tufts Medical Center
    • Michigan
      • Grand Rapids, Michigan, United States, 49503
        • Corewell Health
    • Minnesota
      • Minneapolis, Minnesota, United States, 55407
        • Minneapolis Heart Institute Foundation
    • New Jersey
      • New Brunswick, New Jersey, United States, 08901
        • Rutgers
      • Paramus, New Jersey, United States, 07652
        • The Valley Hospital
    • New York
      • New York, New York, United States, 10075
        • Northwell Health
      • Poughkeepsie, New York, United States, 12601
        • Nuvance Health Hudson Valley Cardiovascular Practice, PC
      • Rochester, New York, United States, 14642
        • University of Rochester
    • Utah
      • Salt Lake City, Utah, United States, 84111
        • Intermountain Health Care, Inc.
    • Virginia
      • Charlottesville, Virginia, United States, 22902
        • University of Virginia Health System
    • West Virginia
      • Morgantown, West Virginia, United States, 26506
        • West Virginia University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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 Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: No-ICD implantation
No-ICD implantation despite current recommendation
Active Comparator: ICD implantation
ICD implantation based on current guidelines
Procedure: ICD implantation
Surgical implant of ICD device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All-cause mortality
Time Frame: through study completion, an average of 3.5 year
Death from any cause
through study completion, an average of 3.5 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Major adverse cardiovascular events
Time Frame: through study completion, an average of 3.5 years
First occurrence of hospitalization for one of the following: stroke, myocardiac infarction, device-related complications, ICD shocks.
through study completion, an average of 3.5 years
Healthcare utilization
Time Frame: through study completion, an average of 3.5 year
Total number of the following events during following: all-cause hospital admissions, emergency department visits, planned and unplanned clinic visits. All events will be captured from electronic medical records
through study completion, an average of 3.5 year
Quality of life, using the Kansas City Cardiomyopathy Questionnaire [KCCQ] and EuroQol-5 Dimension (EQ-5D)
Time Frame: One year
Kansas City Cardiomyopathy Questionnaire [KCCQ] (the KCCQ ranges from 0 to 100, with 0 representing the worst possible health status and 100) and EuroQol-5 Dimension (EQ-5D) (Range from -0.59 to 1, with 1 representing the best possible health state and an index value of less than 0 representing the worst possible health state)
One year
Quality of life, using the EuroQol-5 Dimension (EQ-5D)
Time Frame: One year
Range from -0.59 to 1, with 1 representing the best possible health state and an index value of less than 0 representing the worst possible health state
One year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Rochester

Collaborators

Patient-Centered Outcomes Research Institute

Investigators

  • Principal Investigator: Ilan Goldenberg, MD, Univ of Rochester Medical Center, Clinical Cardiovascular Research Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 4, 2025

Primary Completion (Actual)

April 30, 2026

Study Completion (Actual)

April 30, 2026

Study Registration Dates

First Submitted

July 25, 2024

First Submitted That Met QC Criteria

August 6, 2024

First Posted (Actual)

August 9, 2024

Study Record Updates

Last Update Posted (Actual)

May 12, 2026

Last Update Submitted That Met QC Criteria

May 7, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ADVARRA

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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