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Could botox in the heart stop Post-Surgery AFib?

NCT ID NCT04075981

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 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 01, 2026 · Last updated Jul 02, 2026 · Updated 1 time

Summary

This study tests whether injecting botulinum toxin (Botox) into fat pads around the heart's veins during cardiac surgery can prevent atrial fibrillation (AFib), a common and serious complication. About 220 adults undergoing heart surgery will receive either Botox or a placebo injection. The main goal is to see if Botox reduces AFib episodes in the first three weeks after surgery.

What this could mean

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

Active substance
Botulinum toxin type A (Xeomin)
What this could lead to
If it works, this could offer a new way to prevent a common and serious heart rhythm complication after cardiac surgery.
What could go wrong
This is a single Phase 3 trial with 220 participants. The effect may be modest or not better than placebo, and risks from injecting a neurotoxin near the heart are still being studied.

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

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 220 people

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

Started

Sep 2019

Expected to finish

Sep 2026

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 to 80 years

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: * Indication for cardiac surgery (CABG, aortic valve repair or aortic valve replacement excluding the sutureless valve, ascending aorta surgery), according to the European Heart Association guidelines. * Patients in hemodynamically stable condition. * Sinus rhythm at moment of randomisation (ECG). * Age: ≥18 to ≤80 years old. * Negative serum or urinary β-hCG for women of child-bearing potential. * Patients able to attend several consultations at the centre. * Informed consent signed. * Affiliation to French social security regime. Exclusion Criteria: * Previous cardiac surgery. * Persistent AF or atrial tachycardia. * Planned maze procedure or pulmonary vein (PV) isolation. * Use of class I or III antiarrhythmic drugs within 5 elimination half-life of the drug (for amiodarone: one year). * Mitral or tricuspid valve surgery. * Congenital cardiomyopathy. * Neuro-muscular disease (including disorders of pre-operative swallowing). * Protected populations e.g. minor patient, breastfeeding women, patients under legal guardianship, curatorship or legal protection. . * Participation in another interventional trial. * Unwillingness to participate. * Contraindications to botulinum toxin under investigation or to the excipients: known hypersensitivity. * Patient with active endocarditis Minimal invasive surgery (ministernotomy)

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Conditions

The condition(s) this trial relates to.

aneurysm or dilatation of ascending aorta aortic valve insufficiency aortic valve stenosis coronary artery disorder atrial fibrillation prevention target

As listed by the trial registrant

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

Cardiac surgery

Contacts and locations

Locations

  • CHU Limoges

    Limoges, France, France

  • Clinique Ambroise Paré

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

  • Corentin Celton

    Issy-les-Moulineaux, France, France

  • Hôpital Européen Georges Pompidou

    Paris, Île-de-France Region, 75015, France

  • Hôpital Marie Lannelongue

    Le Plessis-Robinson, France, France

  • Hôpital Saint-Joseph

    Marseille, Provence-Alpes-Côte d'Azur Region, 13008, France

  • Institut Mutualiste Montsouris

    Paris, Île-de-France Region, 75014, France

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