Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

ICD or not? landmark trial tests defibrillator necessity in seniors with heart failure.

NCT ID NCT05373940

Disease control Sponsor: Assistance Publique - Hôpitaux de Paris Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study is testing whether people aged 70 and older with heart failure and a weak heart pump live just as long with only medication as they do with an implanted defibrillator (ICD). The trial will randomly assign 730 participants to receive either an ICD plus medication or medication alone, and track survival over four years. The goal is to see if skipping the ICD is safe and avoids unnecessary procedures in this age group.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Implantable cardioverter defibrillator (ICD)
What this could lead to
If successful, this could show that older heart failure patients can safely skip an ICD and rely on medication alone, avoiding surgery and device risks.
What could go wrong
The trial is still recruiting and results are years away. It may find that skipping the ICD leads to more sudden cardiac deaths, or that the benefit of the ICD is too small to outweigh its risks.

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

About 730 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2022

Expected to finish

May 2030

An estimate. End dates often move.

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

70 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: * ≥70 years old, * Left ventricular ejection fraction ≤ 35%, assessed by echocardiography, single-photon emission computed tomography and radionuclide ventriculography and/or cardiac magnetic resonance (CMR) (assessed at inclusion or within the 6 weeks prior to inclusion). * NYHA class II or III * Heart failure HFOT ≥ 3 months (Possible exceptions : possibility of including patients who do not tolerate the maximum dose or who do not tolerate all four therapeutic classes, as well as the possibility of not waiting for three months when one of the classes is discontinued or when dosage adjustments are made due to poor tolerance ...) * Providing informed consent * Affiliated to a French Health Insurance system. Exclusion Criteria: * Enrolled in or planning to enroll in a conflicting interventional trial (trial evaluating the interest of ICD or modifying HFOT outside the last ESC Guidelines) * Prior unstable sustained ventricular arrhythmia requiring external cardioversion * Myocardial infarction within the 40 days * Coronary artery intervention (catheter or surgical) within 90 days * History of syncope in the previous 6 months * Advanced cerebrovascular disease (cerebrovascular disease with functional repercussions or effect on the patient's autonomy) * Cognitive impairment leading to the incapacity of consent * Any disease other than cardiac disease (e.g. cancer, uremia, liver failure), associated with a likelihood of survival less than 1 year. * Patient under tutorship, curatorship, or legal safeguard * Persons deprived of their liberty by judicial or administrative decision (prisoner)

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Heart failure are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

heart failure sudden arrhythmia death syndrome prevention target

As listed by the trial registrant

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

Heart failure Implantable cardioverter defibrillator Primary prevention of sudden cardiac death

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    19 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • CHU Amiens-Picardie-Site sud

    RECRUITING

    Amiens, 80054, France

  • CHU Brest - Hôpital La Cavale Blanche

    RECRUITING

    Brest, 29200, France

  • CHU Grenoble Alpes

    RECRUITING

    La Tronche, 38700, France

  • CHU Poitiers

    RECRUITING

    Poitiers, 86021, France

  • CHU Strasbourg

    RECRUITING

    Strasbourg, 67200, France

  • CHU de Nantes

    RECRUITING

    Nantes, 44093, France

  • CHU de Rouen

    RECRUITING

    Rouen, 76000, France

  • Centre Cardiologique du Nord

    RECRUITING

    Saint-Denis, 93207, France

  • Centre Hospitalier d'Aix en provence

    RECRUITING

    Aix-en-Provence, 13616, France

  • Clinique Pasteur

    RECRUITING

    Toulouse, 31076, France

  • Groupement d'Hôpitaux de l'Institut Catholique de Lille

    RECRUITING

    Lomme, 59462, France

  • Hôpital Bichat - Claude Bernard

    RECRUITING

    Paris, 75014, France

  • Hôpital Pitié-Salpétrière

    RECRUITING

    Paris, 75013, France

  • Hôpital Pontchaillou

    RECRUITING

    Rennes, 35033, France

  • Hôpital Trousseau

    RECRUITING

    Tours, 37170, France

  • Hôpital de Brabois

    RECRUITING

    Nancy, 54710, France

  • Hôpital de La Timone

    RECRUITING

    Marseille, 13385, France

  • Hôpital européen Georges Pompidou

    RECRUITING

    Paris, , 75015, France

  • HôpitalHenri Mondor

    RECRUITING

    Créteil, 94000, France

More trials for these conditions

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