Prevention of Post-operative Atrial Fibrillation by BOTulinum Toxin Injections Into Epicardial Fat Pads Around Pulmonary Veins in Patients Undergoing Cardiac Surgery

Who is this study for? Patients undergoing cardiac surgery
What treatments are being studied? Botulinum Toxin Type A
Status: Recruiting
Location: See all (9) locations...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
France
Corentin Celton
ACTIVE_NOT_RECRUITING
Issy-les-moulineaux
Hôpital Marie Lannelongue
ACTIVE_NOT_RECRUITING
Le Plessis-robinson
CHU Limoges
ACTIVE_NOT_RECRUITING
Limoges
Hôpital Saint-Joseph
ACTIVE_NOT_RECRUITING
Marseille
Clinique Ambroise Paré
ACTIVE_NOT_RECRUITING
Neuilly-sur-seine
Hôpital Bichat
WITHDRAWN
Paris
Hôpital Européen Georges Pompidou
RECRUITING
Paris
Institut Mutualiste Montsouris
RECRUITING
Paris
Centre Cardiologique du Nord
WITHDRAWN
Saint-denis
Contact Information
Primary
Emmanuelle FLORENS, MD
emmanuelle.florens@aphp.fr
+33(0)1 56 09 31 55
Backup
Laura LE MAO, MSc
laura.le-mao@aphp.fr
+33(0)1 56 09 54 97
Time Frame
Start Date: 2019-09-30
Estimated Completion Date: 2026-09-30
Participants
Target number of participants: 220
Treatments
Experimental: Botulinum toxin
All patients from the experimental group will receive botulinum toxin (Xeomin®, incobotulinumtoxin A, Merz Pharma GmbH \& Co KGaA, Germany; 200 U dissolved in 4 mL of 0.9% normal saline and 50 U/1 mL will be injected at each fat pad).~Botulinum toxin will be injected into the entire visible area of the 4 major epicardial fat pads, during extra corporal circulation and before aortic cross clamping in order to reduce the time of ischemia.~The whole estimated dosage would be therefore 200 units of incobotulinumtoxin A,
Placebo_comparator: Placebo
All patients from the control group will receive placebo. Before the main stage of the surgery, during extra corporal circulation and before aortic cross clamping, the placebo dissolved in 4 mL of 0.9% normal saline will be injected into the entire visible area of the 4 major epicardial fat pads as follows (1 mL at each fat pad).
Related Therapeutic Areas
Sponsors
Collaborators: Ministry of Health, France, Merz Pharmaceuticals
Leads: Assistance Publique - Hôpitaux de Paris

This content was sourced from clinicaltrials.gov