Actively Recruiting
Prevention Atrial Fibrillation by BOTulinum Toxin Injections (BOTAF)
Led by Assistance Publique - Hôpitaux de Paris · Updated on 2025-05-16
220
Participants Needed
9
Research Sites
365 weeks
Total Duration
On this page
Sponsors
A
Assistance Publique - Hôpitaux de Paris
Lead Sponsor
M
Merz Pharmaceuticals
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Prevention Atrial Fibrillation by BOTulinum Toxin Injections (BOTAF)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Indication for cardiac surgery including CABG, aortic valve repair or replacement (excluding sutureless valve), or ascending aorta surgery
- Hemodynamically stable patients
- Sinus rhythm at time of randomization (confirmed by ECG)
- Age between 18 and 80 years old
- Negative serum or urinary beta-hCG for women of child-bearing potential
- Ability to attend multiple consultations at the study center
- Signed informed consent
- Affiliated with French social security system
You will not qualify if you...
- Previous cardiac surgery
- Persistent atrial fibrillation or atrial tachycardia
- Planned maze procedure or pulmonary vein isolation
- Use of class I or III antiarrhythmic drugs within 5 elimination half-lives (for amiodarone: within one year)
- Mitral or tricuspid valve surgery
- Congenital cardiomyopathy
- Neuromuscular disease including pre-operative swallowing disorders
- Protected populations such as minors, breastfeeding women, or those under legal guardianship
- Participation in another interventional clinical trial
- Unwillingness to participate
- Known hypersensitivity or contraindication to botulinum toxin or its excipients
- Active endocarditis
- Minimally invasive surgery such as ministernotomy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 9 locations
1
Corentin Celton
Issy-les-Moulineaux, France, France
Active, Not Recruiting
2
Hôpital Marie Lannelongue
Le Plessis-Robinson, France, France
Active, Not Recruiting
3
CHU Limoges
Limoges, France, France
Active, Not Recruiting
4
Hôpital Saint-Joseph
Marseille, Provence-Alpes-Côte d'Azur Region, France, 13008
Active, Not Recruiting
5
Clinique Ambroise Paré
Neuilly-sur-Seine, Île-de-France Region, France, 92200
Active, Not Recruiting
6
Institut Mutualiste Montsouris
Paris, Île-de-France Region, France, 75014
Actively Recruiting
7
Hôpital Européen Georges Pompidou
Paris, Île-de-France Region, France, 75015
Actively Recruiting
8
Hôpital Bichat
Paris, Île-de-France Region, France, 75877
Withdrawn
9
Centre Cardiologique du Nord
Saint-Denis, Île-de-France Region, France, 93200
Withdrawn
Research Team
E
Emmanuelle FLORENS, MD
CONTACT
L
Laura LE MAO, MSc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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