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BOTAF - Prevention of post-operative Atrial Fibrillation by BOTulinum toxin injections into epicardial fat pads around pulmonary veins in patients undergoing cardiac surgery
EU CTIS ID: 2024-513645-37-00
What this study is testing
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
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- - 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.
You likely can't join if
- - 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).
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.