Prevention of post-operative Atrial Fibrillation by BOTulinum toxin injections into epicardial fat pads around pulmonary veins in patients undergoing cardiac surgery - BOTAF

Overview

No summary available.

Registry

who.int

Start Date

February 5, 2019

End Date

TBD

Last Updated

6 years ago

Study Type

Interventional clinical trial of medicinal product

Sponsor

•\-Indication for cardiac surgery (CABG, aortic valve repair or replacement surgery, ascending aorta surgery), according to the European Heart Association guidelines.
•\-Patients in hemodynamically stable condition.
•\-Sinus rhythm at moment of randomisation.
•\-Age: \=18 to \=80 years old.
•\-Negative serum or urinary ß\-hCG for premenopausal women.
•\-Patients able to attend several consultations at the centre.
•\-Informed consent signed.
•\-Affiliation to French social security regime.
•Are the trial subjects under 18? no
•Number of subjects for this age range:

•\-Previous cardiac surgery.
•\-Preoperative history of persistent AF or atrial tachycardia.
•\-Planned maze procedure or pulmonary vein (PV) isolation.
•\-Use of class I or III antiarrhythmic drugs within 5 elimination half\-life of the drug (for amiodarone: one year).
•\-Mitral or tricuspid valve surgery.
•\-Congenital cardiomyopathy.
•\-Neuro\-muscular disease.
•\-Protected populations e.g. breastfeeding women, patients under legal tutorship or curatorship.
•\-Participation in another interventional trial.
•\-Unwillingness to participate.