Informations générales (source: ClinicalTrials.gov)
Prevention of Post-operative Atrial Fibrillation by BOTulinum Toxin Injections Into Epicardial Fat Pads Around Pulmonary Veins in Patients Undergoing Cardiac Surgery"
Interventional
Phase 3
Assistance Publique - Hôpitaux de Paris (Voir sur ClinicalTrials)
septembre 2019
septembre 2026
18 septembre 2025
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CENTRE CARDIOLOGIQUE DU NORD | FLORENS Emmanuelle | 18/09/2025 17:39:13 | Contacter | ||
| CLINIQUE CHIRURGICAL AMBROISE PARE | FLORENS Emmanuelle | 18/09/2025 17:39:13 | Contacter | ||
| HOPITAL MARIE LANNELONGUE | FLORENS Emmanuelle | 18/09/2025 17:39:12 | Contacter | ||
| INSTITUT MUTUALISTE MONTSOURIS | FLORENS Emmanuelle | 18/09/2025 17:39:12 | Contacter | ||
| AP-HP Assistance publique - Hôpitaux de Paris | 18/09/2025 17:39:13 | Contacter | |||
| AP-HP - Hôpital Bichat | |||||
| AP-HP - Hôpital Corentin Celton | |||||
| AP-HP - Hôpital Europeen Georges Pompidou | |||||
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| 18/09/2025 17:39:12 | Contact (sur clinicalTrials) | ||||
| 18/09/2025 17:39:12 | Contact (sur clinicalTrials) | ||||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| CHU Limoges - Limoges - France | Contact (sur clinicalTrials) | ||||
| Clinique Ambroise Paré - 92200 - Neuilly-sur-Seine - Ile-de-France - France | Contact (sur clinicalTrials) | ||||
| Hôpital Marie Lannelongue - Le Plessis-Robinson - France | Contact (sur clinicalTrials) | ||||
| Hôpital Saint-Joseph - 13008 - Marseille - Provence-Alpes-Côte d'Azur - France | Contact (sur clinicalTrials) | ||||
| Institut Mutualiste Montsouris - 75014 - Paris - Ile-de-France - France | Milena NOGHIN | Contact (sur clinicalTrials) | |||
Critères
Tous
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.
- 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.
- 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)