RecruitingPhase 3NCT04075981

Prevention Atrial Fibrillation by BOTulinum Toxin Injections (BOTAF)

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

Sponsor

Assistance Publique - Hôpitaux de Paris

Enrollment

220 participants

Start Date

Sep 30, 2019

Study Type

INTERVENTIONAL

Conditions

Cardiac Surgery

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

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether injecting botulinum toxin (Botox) into fat pads around the heart during cardiac surgery can help prevent atrial fibrillation (an irregular heartbeat) from developing after the operation. Post-surgical atrial fibrillation is a common complication and can cause serious problems. **You may be eligible if...** - You are between 18 and 80 years old - You are scheduled for cardiac surgery (such as bypass surgery, aortic valve repair or replacement, or ascending aorta surgery) - You are in a stable heart rhythm (sinus rhythm) at the time of enrollment - You are enrolled in French social security - If you are a woman of childbearing age, you have a negative pregnancy test **You may NOT be eligible if...** - You have had previous cardiac surgery - You already have persistent atrial fibrillation or atrial tachycardia - You are taking certain anti-arrhythmic medications - You are planned for a maze procedure or pulmonary vein isolation at the time of surgery Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBotulinum Toxin Type A Injection [Xeomin]

Before the main stage of the surgery, 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.

OTHERDrug 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 will be injected into the entire visible area of the 4 major epicardial fat pads as follows (1 mL at each fat pad).