Actively Recruiting

Phase 3
Age: 18Years - 80Years
All Genders
NCT04075981

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

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

1
2
3
+1

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

Loading map...

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

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here