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Heart study asks: do ICDs help Low-Risk patients?

NCT ID NCT06543446

Knowledge-focused Sponsor: University of Rochester Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at whether implantable defibrillators (ICDs) help people with heart failure and a lower risk of deadly heart rhythms live longer compared to not having an ICD. It involved over 3,000 adults with weak heart pumps. The goal was to see if the benefits of ICDs still hold in today's better-treated heart failure patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

3,290 people

The number who actually took part.

Started

Mar 2025

Finished

Apr 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Death, Sudden, Cardiac heart failure systolic heart failure

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Heart failure with reduced ejection fraction

Contacts and locations

Locations

  • Corewell Health

    Grand Rapids, Michigan, 49503, United States

  • Intermountain Health Care, Inc.

    Salt Lake City, Utah, 84111, United States

  • Johns Hopkins University

    Baltimore, Maryland, 21287, United States

  • MaineHealth

    Portland, Maine, 04102, United States

  • Minneapolis Heart Institute Foundation

    Minneapolis, Minnesota, 55407, United States

  • Northwell Health

    New York, New York, 10075, United States

  • Nuvance Health Hudson Valley Cardiovascular Practice, PC

    Poughkeepsie, New York, 12601, United States

  • Rutgers

    New Brunswick, New Jersey, 08901, United States

  • The Valley Hospital

    Paramus, New Jersey, 07652, United States

  • Tufts Medical Center

    Boston, Massachusetts, 02111, United States

  • University of Alberta

    Edmonton, Alberta, T6G 2B7, Canada

  • University of Calgary

    Calgary, Alberta, T2N4Z6, Canada

  • University of Rochester

    Rochester, New York, 14642, United States

  • University of Virginia Health System

    Charlottesville, Virginia, 22902, United States

  • West Virginia University

    Morgantown, West Virginia, 26506, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.