NCT04075981Active, not recruitingPhase 3
Prevention Atrial Fibrillation by BOTulinum Toxin Injections (BOTAF)
Prevention of Post-operative Atrial Fibrillation by BOTulinum Toxin Injections Into Epicardial Fat Pads Around Pulmonary Veins in Patients Undergoing Cardiac Surgery"
Source: ClinicalTrials.gov · Last updated 1 Jul 2026
Brief summary (registry, in English)
Over the past few years, research has focused on the prevention of atrial fibrillation (AF) after cardiac surgery, but highly effective interventions are still missing. Postoperative AF remains the most common complication after cardiac surgery, with an incidence of 10 to 50%. This complication is usually a transient condition that resolves spontaneously but it has major adverse consequences for patients and the health care system, including increased rates of death, complications (strokes), and hospitalisations with inflated costs. Recently, animal studies have demonstrated that neurotoxins such as botulinum toxin (BTX) injected into fat pads could suppress AF inducibility by parasympathetic activation. Botulinum toxin injection in fat pads has been studied in the dog's heart and could be associated with the reduction of atrial fibrillation in postoperative cardiac surgery. One pilot study has demonstrated the feasibility and safety of this technique in the human heart. The investigators hypothesize that botulinum toxin injection may substantially reduce postoperative AF during the first postoperative month after cardiac surgery without any serious adverse events. By the suppression of ganglionic plexi (GP) activity in the epicardial fat pads, mild term antiarrhythmic effects can be achieved with fewer antiarrhythmic drugs and anticoagulant treatment.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 220 (estimated)
- First submitted
- 19 Aug 2019
- Start date
- 30 Sept 2019
- Primary completion date
- 13 Oct 2025
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Diseases
- Atrial fibrillation
- NCT number
- NCT04075981
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 220
- From 30 Sept 2019 to the primary completion date, 13 Oct 2025
- 7 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous cardiac surgery.
- 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.
- Patient with active endocarditis Minimal invasive surgery (ministernotomy)
Other illness
- Neuro-muscular disease (including disorders of pre-operative swallowing).
- Contraindications to botulinum toxin under investigation or to the excipients: known hypersensitivity.
Other
- Persistent AF or atrial tachycardia.
- Planned maze procedure or pulmonary vein (PV) isolation.
- Congenital cardiomyopathy.
- Protected populations e.g. minor patient, breastfeeding women, patients under legal guardianship, curatorship or legal protection. .
- Participation in another interventional trial.
- Unwillingness to participate.
Who the study is looking for
- 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.
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (7)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Corentin Celton Coordinator of this site? Confirm its status | Issy-les-Moulineaux | France | Unknown status |
| Hôpital Marie Lannelongue Coordinator of this site? Confirm its status | Le Plessis-Robinson | France | Unknown status |
| CHU Limoges Coordinator of this site? Confirm its status | Limoges | France | Unknown status |
| Hôpital Saint Joseph Coordinator of this site? Confirm its status | Marseille | France | Unknown status |
| Clinique Ambroise Pare Coordinator of this site? Confirm its status | Neuilly-sur-Seine | France | Unknown status |
| Hôpital Européen Georges Pompidou Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| Institut Mutualiste Montsouris Coordinator of this site? Confirm its status | Paris | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.