BOTAF - Prevention of post-operative Atrial Fibrillation by BOTulinum toxin injections into epicardial fat pads around pulmonary veins in patients undergoing cardiac surgery
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 220
- 试验地点
- 6
- 主要终点
- The incidence of rhythm disorders of postoperative AF in patients undergoing cardiac surgery at 3 weeks defined as atrial arrhythmia during at least 30 seconds continuously within 21 days after cardiac surgery. It will be measured through both holter ECG Spiderflash-t recorder during the first 21 days post-op and ECG daily monitoring during the first 7 days after surgery. Two blinded cardiologists will independently adjudicate the primary end point.
研究概览
简要总结
To determine the efficacy of Botulinum toxin injection into epicardial fat pads for the prevention of postoperative AF in patients undergoing cardiac surgery within three weeks following cardiac surgery
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •Previous cardiac surgery. - 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 including disorders of pre-operative swallowing - Protected populations e.g. minor patient, breastfeeding women, patients under legal guardianship, curatorship or legal protection. . - Participation in another interventional trial. - Unwillingness to participate. - Contraindications to botulinum toxin under investigation or to the excipients: known hypersensitivity. - Patient with active endocarditis. - Minimal invasive surgery (ministernotomy).
结局指标
主要结局
The incidence of rhythm disorders of postoperative AF in patients undergoing cardiac surgery at 3 weeks defined as atrial arrhythmia during at least 30 seconds continuously within 21 days after cardiac surgery. It will be measured through both holter ECG Spiderflash-t recorder during the first 21 days post-op and ECG daily monitoring during the first 7 days after surgery. Two blinded cardiologists will independently adjudicate the primary end point.
The incidence of rhythm disorders of postoperative AF in patients undergoing cardiac surgery at 3 weeks defined as atrial arrhythmia during at least 30 seconds continuously within 21 days after cardiac surgery. It will be measured through both holter ECG Spiderflash-t recorder during the first 21 days post-op and ECG daily monitoring during the first 7 days after surgery. Two blinded cardiologists will independently adjudicate the primary end point.
次要结局
未报告次要终点
研究者
Dr Emmanuelle FLORENS
Scientific
Assistance Publique Hopitaux De Paris