Preventing Atrial Fibrillation with Botulinum Toxin Injections
Prevention of Post-operative Atrial Fibrillation by BOTulinum Toxin Injections Into Epicardial Fat Pads Around Pulmonary Veins in Patients Undergoing Cardiac Surgery"
This study is testing whether botulinum toxin injections can help prevent atrial fibrillation in patients having heart surgery.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 220 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 9 sites (Issy-les-Moulineaux, France and 8 other locations) |
| Trial ID | NCT04075981 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the use of botulinum toxin injections to prevent atrial fibrillation (AF) in patients undergoing cardiac surgery. The study aims to assess the efficacy and safety of this intervention in reducing the incidence of postoperative AF, which is a common complication following such surgeries. By targeting the epicardial fat pads and suppressing ganglionic plexi activity, the researchers hypothesize that botulinum toxin may provide antiarrhythmic effects and reduce the need for additional medications. The trial will involve a randomized multicenter approach, enrolling patients who meet specific eligibility criteria.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 80 who are scheduled for cardiac surgery and are in stable condition with sinus rhythm.
Not a fit: Patients with a history of previous cardiac surgery, persistent atrial fibrillation, or those requiring specific antiarrhythmic treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the occurrence of postoperative atrial fibrillation, improving patient outcomes and reducing healthcare costs.
How similar studies have performed: While there has been limited research on the use of botulinum toxin in cardiology, a pilot study has shown promising results, indicating potential for this novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Issy-les-Moulineaux, France and 8 other locations
- Corentin Celton — Issy-les-Moulineaux, France, France (Active_not_recruiting)
- Hôpital Marie Lannelongue — Le Plessis-Robinson, France, France (Active_not_recruiting)
- CHU Limoges — Limoges, France, France (Active_not_recruiting)
- Hôpital Saint-Joseph — Marseille, Provence-Alpes-Côte d'Azur Region, France (Active_not_recruiting)
- Clinique Ambroise Paré — Neuilly-sur-Seine, Île-de-France Region, France (Active_not_recruiting)
- Institut Mutualiste Montsouris — Paris, Île-de-France Region, France (Recruiting)
- Hôpital Européen Georges Pompidou — Paris, Île-de-France Region, France (Recruiting)
- Hôpital Bichat — Paris, Île-de-France Region, France (Withdrawn)
- Centre Cardiologique du Nord — Saint-Denis, Île-de-France Region, France (Withdrawn)
Study contacts
- Principal investigator: FLORENS Emmanuelle, MD — Assistance Publique - Hôpitaux de Paris
- Study coordinator: Emmanuelle FLORENS, MD
- Email: emmanuelle.florens@aphp.fr
- Phone: +33(0)1 56 09 31 55
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.