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New heart procedure may cause temporary diaphragm paralysis – study investigates

NCT ID NCT07462910

Knowledge-focused Sponsor: French Cardiology Society Source: ClinicalTrials.gov ↗

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 will use a special X-ray technique called fluoroscopy to check how often the diaphragm becomes temporarily paralyzed after pulsed field ablation, a newer treatment for atrial fibrillation. Researchers will monitor 250 adults before and after the procedure to detect any changes in diaphragm movement. The goal is to better understand this side effect and improve patient safety.

What this could mean

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

What this could lead to
If successful, this study could help doctors understand the true risk of diaphragm paralysis after pulsed field ablation and improve safety monitoring.
What could go wrong
This is an observational study, not a treatment trial. It only measures a side effect and does not test a new therapy or change outcomes for participants.

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 250 people

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

Started

Jun 2026

Expected to finish

May 2027

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

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: * Men and women aged 18 years or older at the time of signing the consent (age≥ 18). * Diagnosis of paroxysmal or persistent atrial fibrillation, documented in any type of means: ECG, Holter, invasive monitoring (memories of an implantable device) or not (connected objects). * Indication for ablation decided as part of routine care, according to the recommendations of learned societies. * First, ablation procedure (including pulmonary vein isolation) planned with the use of a commercially available Pulsed Field Ablation catheter. * Possibility of performing a fluoroscopic diaphragmatic evaluation before and after the operation (before discharge from the hospital). * Free, informed and signed consent by the patient before any data collection Exclusion Criteria: * Known history of diaphragmatic paralysis (right or bilateral) or pre-existing clinical suspicion. * History of atrial fibrillation ablation. * History of neuromuscular disease. * History of major thoracic surgery or chronic pulmonary pathology that may impair diaphragmatic kinetics. * Evidence of diaphragmatic paralysis on the pre-procedure fluoroscopy loop, defined as: * Cranio-caudal excursion amplitude ≤35 mm on both hemidiaphragms, Or * An asymmetry in contraction amplitude ≥15% between the two sides. * Inability to perform a post-procedure follow-up fluoroscopy (logistical limitation, patient refusal, contraindication to irradiation). * Pregnancy or breastfeeding in progress. * Concurrent participation in another interventional study that may interfere with the objectives of this research. * Major impairment in cognitive function or inability to understand the objectives of the study or sign a valid consent. * Individuals deprived of liberty by judicial or administrative decision. * Adults subject to a legal protection measure (guardianship, curatorship, or judicial protection/safeguard of justice). * Individuals unable to provide informed consent.

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Conditions

The condition(s) this trial relates to.

atrial fibrillation

As listed by the trial registrant

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

Atrial fibrillation

How to take part

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

  1. The places running it

    9 sites in 3 countries. 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

  • Auckland City Hospital

    NOT_YET_RECRUITING

    Auckland, 1023, New Zealand

  • CHRU de Tours - Hôpital Trousseau

    NOT_YET_RECRUITING

    Chambray-lès-Tours, 37170, France

  • CHU de Bordeaux - Hôpital Haut-Lévêque

    NOT_YET_RECRUITING

    Pessac, 33604, France

  • CHU de Lyon - Hôpital Croix-Rousse

    NOT_YET_RECRUITING

    Lyon, 69004, France

  • Centre Cardiologique du Nord

    NOT_YET_RECRUITING

    Saint-Denis, 93200, France

  • Centre Hospitalier de Pau - Hôpital François Mitterrand

    RECRUITING

    Pau, 64046, France

  • Clinique Pasteur

    NOT_YET_RECRUITING

    Toulouse, 31300, France

  • Institut Cardiovasculaire de Strasbourg - Clinique Rhéna

    NOT_YET_RECRUITING

    Strasbourg, 67000, France

  • Montreal Heart Institute

    NOT_YET_RECRUITING

    Montreal, QC H1T 1C8, Canada

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