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

ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)0 个研究点目标入组 220 人开始时间: 2019年2月5日最近更新: 2019年6月30日

试验速览

暂无简介。

•-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:
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range 40
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range 60

•-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.
•-Contraindications to botulinum toxin under investigation or to the excipients: known hypersensitivity.

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