Prevention Atrial Fibrillation by BOTulinum Toxin Injections (BOTAF)
Status:
Recruiting
Trial end date:
2023-09-01
Target enrollment:
Participant gender:
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 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.
Phase:
Phase 3
Details
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborators:
Merz Pharmaceuticals Netherlands: Ministry of Health, Welfare and Sports
Treatments:
abobotulinumtoxinA Botulinum Toxins Botulinum Toxins, Type A incobotulinumtoxinA