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

Phase 1

• Conditions: Adult patients with indication for conventional cardiac surgery (CABG, aortic replacement, or ascending aorta surgery) will be eligible; MedDRA version: 20.1 Level: LLT Classification code 10067824 Term: Prophylaxis against atrial fibrillation System Organ Class: 100000004865; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2018-002541-11-FR
• Lead Sponsor: ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-02-05
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 220

Inclusion Criteria

-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

Exclusion Criteria

-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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified