Status:
RECRUITING
Prevention Atrial Fibrillation by BOTulinum Toxin Injections (BOTAF)
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborating Sponsors:
Merz Pharmaceuticals
Ministry of Health, France
Conditions:
Cardiac Surgery
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief Summary
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 mo...
Detailed Description
Botulinium toxin use has been developed with success in wide-ranging fields (neurology, otorhinolaryngology, gynaecology, urology, plastic surgery, pain therapy), but not in cardiology. In the cardio...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
September 30 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2026
Estimated Enrollment :
220 Patients enrolled
Trial Details
Trial ID
NCT04075981
Start Date
September 30 2019
End Date
September 30 2026
Last Update
May 16 2025
Active Locations (9)
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1
Corentin Celton
Issy-les-Moulineaux, France, France
2
Hôpital Marie Lannelongue
Le Plessis-Robinson, France, France
3
CHU Limoges
Limoges, France, France
4
Hôpital Saint-Joseph
Marseille, Provence-Alpes-Côte d'Azur Region, France, 13008