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New study aims to spot hidden breathing muscle damage from heart procedure

NCT ID NCT07127900

Knowledge-focused Sponsor: Laurent Macle 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 Results may not be published yet.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
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled This study
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This status has not been confirmed recently, so it may be out of date.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 looks at a possible side effect of a heart treatment called PFA for atrial fibrillation: injury to the phrenic nerve, which can paralyze part of the diaphragm and affect breathing. Patients get a special X-ray before and after the procedure to check diaphragm movement. If an issue is found, they are followed for up to a year. The study is purely observational and does not change standard care.

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.

Expected to start

Oct 2025

An estimate. Start dates often move.

Expected to finish

Apr 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.

Who is studied

The study plans to include 250 consecutive patients undergoing atrial fibrillation ablation by PFA, regardless of the "one-shot" system used (FARAPULSE™, PULSE SELECT™, VARIPULSE™, or VOLT™), at the discretion of each operator.

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: * Diagnosis of paroxysmal or persistent atrial fibrillation (AF), documented by any method: ECG, Holter, invasive monitoring (implantable device memory), or non-invasive monitoring (connected devices). * Ablation indication decided as part of routine care, according to society guidelines. * First ablation procedure (including pulmonary vein isolation) planned using a commercially available PFA catheter. * Ability to perform diaphragmatic fluoroscopic evaluation before and after the procedure (before hospital discharge). Exclusion Criteria: * Patients presenting with one or more of the following conditions will be excluded from the study: * Known history of diaphragmatic paralysis (right-sided or bilateral) or preexisting clinical suspicion. * History of atrial fibrillation ablation. * History of neuromuscular disease. * History of major thoracic surgery or chronic pulmonary pathology likely to impair diaphragmatic motion. * Diaphragmatic paralysis diagnosed during the pre-procedure fluoroscopic assessment. * Inability to perform post-procedure fluoroscopic control (due to logistical limitations, patient refusal, or contraindication to radiation exposure). * Current pregnancy or breastfeeding. * Concurrent participation in another interventional study that may interfere with the objectives of the present research. * Significant cognitive impairment or inability to understand the study objectives or provide valid consent.

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Conditions

The condition(s) this trial relates to.

atrial fibrillation respiratory paralysis

As listed by the trial registrant

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

Atrial fibrillation (AF) Phrenic nerve-related diaphragmatic impairment

More trials for these conditions

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