NCT06543446

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).

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,290

participants targeted

Target at P75+ for not_applicable

Timeline
59mo left

Started Mar 2025

Longer than P75 for not_applicable

Geographic Reach
2 countries

15 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress20%
Mar 2025Feb 2031

First Submitted

Initial submission to the registry

July 25, 2024

Completed
15 days until next milestone

First Posted

Study publicly available on registry

August 9, 2024

Completed
7 months until next milestone

Study Start

First participant enrolled

March 4, 2025

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2030

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2031

Last Updated

January 9, 2026

Status Verified

January 1, 2026

Enrollment Period

5.5 years

First QC Date

July 25, 2024

Last Update Submit

January 7, 2026

Conditions

Heart Failure With Reduced Ejection Fraction

Keywords

Implantable cardioverter defibrillatorSudden cardiac deathguideline directed medical therapy

Outcome Measures

Primary Outcomes (1)

  • All-cause mortality

    Death from any cause

    through study completion, an average of 3.5 year

Secondary Outcomes (4)

  • Major adverse cardiovascular events

    through study completion, an average of 3.5 years

  • Healthcare utilization

    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)

    One year

  • Quality of life, using the EuroQol-5 Dimension (EQ-5D)

    One year

Study Arms (2)

No-ICD implantation

NO INTERVENTION

No-ICD implantation despite current recommendation

ICD implantation

ACTIVE COMPARATOR

ICD implantation based on current guidelines

Procedure: ICD implantation

Interventions

ICD implantationPROCEDURE

Surgical implant of ICD device

ICD implantation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

MaineHealth

Portland, Maine, 04102, United States

RECRUITING

Johns Hopkins University

Baltimore, Maryland, 21287, United States

RECRUITING

Tufts Medical Center

Boston, Massachusetts, 02111, United States

RECRUITING

Corewell Health

Grand Rapids, Michigan, 49503, United States

RECRUITING

Minneapolis Heart Institute Foundation

Minneapolis, Minnesota, 55407, United States

RECRUITING

Rutgers

New Brunswick, New Jersey, 08901, United States

RECRUITING

The Valley Hospital

Paramus, New Jersey, 07652, United States

RECRUITING

Northwell Health

New York, New York, 10075, United States

RECRUITING

Nuvance Health Hudson Valley Cardiovascular Practice, PC

Poughkeepsie, New York, 12601, United States

RECRUITING

University of Rochester

Rochester, New York, 14642, United States

RECRUITING

Intermountain Health Care, Inc.

Salt Lake City, Utah, 84111, United States

RECRUITING

University of Virginia Health System

Charlottesville, Virginia, 22902, United States

RECRUITING

West Virginia University

Morgantown, West Virginia, 26506, United States

RECRUITING

University of Calgary

Calgary, Alberta, T2N4Z6, Canada

RECRUITING

University of Alberta

Edmonton, Alberta, T6G 2B7, Canada

RECRUITING

Related Publications (2)

  • Fiuzat M, Hamo CE, Butler J, Abraham WT, DeFilippis EM, Fonarow GC, Lindenfeld J, Mentz RJ, Psotka MA, Solomon SD, Teerlink JR, Vaduganathan M, Vardeny O, McMurray JJV, O'Connor CM. Optimal Background Pharmacological Therapy for Heart Failure Patients in Clinical Trials: JACC Review Topic of the Week. J Am Coll Cardiol. 2022 Feb 8;79(5):504-510. doi: 10.1016/j.jacc.2021.11.033.

    PMID: 35115106BACKGROUND

  • Goldenberg I, Zareba W, Ezekowitz JA, Albert C, Alexis JD, Anderson L, Behr ER, Daubert J, Di Palo KE, Ellenbogen KA, Dzikowicz DJ, Harrington JM, Hsich E, Huang DT, Januzzi JL, Jawaid A, Kutyifa V, Lala-Trindade A, Nakonechnyi A, Onwuanyi A, Pina IL, Sandhu RK, Sears S, Sroubek J, Baykaner T, Strawderman R, Beck C, Butler J. Rationale and design of the comparative effectiveness of ICD vs non-ICD therapy in contemporary heart failure patients at a low risk for arrhythmic death (CONTEMP-ICD) trial. Am Heart J. 2026 Jan;291:162-174. doi: 10.1016/j.ahj.2025.08.020. Epub 2025 Sep 4.

    PMID: 40914445DERIVED

MeSH Terms

Conditions

Death, Sudden, Cardiac

Condition Hierarchy (Ancestors)

Heart ArrestHeart DiseasesCardiovascular DiseasesDeath, SuddenDeathPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Ilan Goldenberg, MD

    Univ of Rochester Medical Center, Clinical Cardiovascular Research Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ilan Goldenberg

CONTACT

585-275-5391ilan.goldenberg@heart.rochester.edu

Ann Colasurdo

CONTACT

585-275-1054ann_colasurdo@urmc.rochester.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

July 25, 2024

First Posted

August 9, 2024

Study Start

March 4, 2025

Primary Completion (Estimated)

August 31, 2030

Study Completion (Estimated)

February 28, 2031

Last Updated

January 9, 2026

Record last verified: 2026-01

Locations

US(13)CA(2)