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Study checks if testing heart devices during replacement is worthwhile

NCT ID NCT04206371

Knowledge-focused Sponsor: CMC Ambroise Paré 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study followed 143 people who had a defibrillator (ICD) replaced to see if testing the device's ability to deliver a shock is safe and useful. The test involves briefly inducing a fast heart rhythm under anesthesia. The goal was to check for device problems, like abnormal shock impedance, that might need fixing. The study did not test a new treatment but aimed to improve how doctors manage ICD replacements.

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

143 people

The number who actually took part.

Started

Feb 2020

Finished

Jun 2023

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: * Patients with an ICD (VR or DR) or CRT-D undergoing generator replacement. * Consent for participation * Affiliation to the French social security system Exclusion Criteria: * Atrial Fibrillation without effective anti-coagulation treatments. * Severe Aortic valve stenosis * Stroke occurred in the previous month * Hemodynamic instability contraindicating the high energy shock * Contraindication for anesthesia * Pregnant or breastfeeding women * Communication difficulties or neuropsychiatric disorder * Patients under protection of the adults (guardianship, curators or safeguard of justice)

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As listed by the trial registrant

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

Implantable cardioverter-defibrillators

Contacts and locations

Locations

  • CHU de Caen

    Caen, Normandy, 14000, France

  • CHU de Toulouse-Hôpital Rangueil

    Toulouse, Occitanie, 31400, France

  • CMC Ambroise Paré

    Neuilly-sur-Seine, Île-de-France Region, 92200, France

  • Centre Hospitalier Henri Duffaut

    Avignon, Provence-Alpes-Côte d'Azur Region, 84902, France

  • Hôpital Privé du Confluent

    Nantes, Pays de la Loire Region, 44277, France

  • Hôpital Trousseau

    Chambray-lès-Tours, Centre-Val de Loire, 37170, France

  • Institut Lorrain du Coeur et des Vaisseaux Louis Mathieu-CHU de Nancy-Hôpitaux de Brabois

    Vandœuvre-lès-Nancy, Grand Est, 54500, France