Prevention Atrial Fibrillation by BOTulinum Toxin Injections (BOTAF)

Launched by ASSISTANCE PUBLIQUE - HÔPITAUX DE PARIS · Aug 29, 2019

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ClinConnect Summary

The BOTAF trial is studying whether injecting botulinum toxin (a substance sometimes used for cosmetic treatments) into specific areas of the heart can help prevent atrial fibrillation (AF) after heart surgery. Atrial fibrillation is a common heart rhythm problem that can occur after surgery, affecting 10 to 50% of patients. Although AF often goes away on its own, it can lead to serious health issues like strokes and longer hospital stays. This study aims to see if the botulinum toxin injections can significantly reduce the chances of developing AF in the first month after surgery, without causing serious side effects.

To participate in this trial, patients must be between 18 and 80 years old and scheduled for certain types of heart surgeries, like bypass surgery or valve repairs. They should be in stable health and have a normal heart rhythm at the time of enrollment. Participants will be monitored closely and may need to attend several follow-up visits. It's important to know that if someone has had previous heart surgery or certain other heart conditions, they may not qualify for this trial. Overall, this study hopes to find a new way to help heart surgery patients avoid complications related to atrial fibrillation.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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.
• Exclusion Criteria:
• • 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)