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

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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-002541-11-FR

Enrollment

220

Registered

2019-02-05

Start date

2019-06-06

Completion date

Unknown

Last updated

2024-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

Interventions

Trade Name: Xeomin® 200 U Product Name: XEOMIN Pharmaceutical Form: Powder for solution for injection Pharmaceutical form of the placebo: Powder for solution for injection Route of administration of t

Eligibility

Sex/Gender

All

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
Main Objective: The main objective of this trial is 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 months following cardiac surgery.;Secondary Objective: Secondary objectives are to evaluate feasibility and tolerance, i.e. to assess the prevention of atrial tachyarrhythmia (not only AF but also atrial flutter, atrial tachycardia), safety of the surgical procedure, and to assess the total cost and incremental cost effectiveness.;Primary end point(s): The primary endpoint is the incidence of new onset of postoperative AF in patients undergoing cardiac surgery at 3 months defined as atrial arrhythmia during at least 30 seconds continuously. Two blinded cardiologists will independently adjudicate the primary end point.;Timepoint(s) of evaluation of this end point: at 3 months	—

Measure

Time frame

Main Objective: The main objective of this trial is 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 months following cardiac surgery.;Secondary Objective: Secondary objectives are to evaluate feasibility and tolerance, i.e. to assess the prevention of atrial tachyarrhythmia (not only AF but also atrial flutter, atrial tachycardia), safety of the surgical procedure, and to assess the total cost and incremental cost effectiveness.;Primary end point(s): The primary endpoint is the incidence of new onset of postoperative AF in patients undergoing cardiac surgery at 3 months defined as atrial arrhythmia during at least 30 seconds continuously. Two blinded cardiologists will independently adjudicate the primary end point.;Timepoint(s) of evaluation of this end point: at 3 months

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Secondary

Measure	Time frame
Secondary end point(s): - Death rate at 12 months. - Rate of major adverse cardiovascular events at 3 months: conduction troubles such as atrioventricular block or the need for transient or permanent placement of a pacemaker, congestive heart failure, major bleeding, stroke and arterial thromboembolic events. - Adverse events (AE) and serious adverse events (SAE) by treatment group. - Incidence of atrial tachyarrhythmia including atrial fibrillation, but also atrial flutter and atrial tachycardia at 3 months, and each arrhythmia individually. - Incidence of new onset of postoperative AF depending on the following subgroups: age, gender, heart failure (defined by left ventricular ejection fraction 52 mL/m2) or LA diameter index > 48 mm/m2, EuroSCORE 2, eGFR < 60 mL/min / 1.73m2. - Intervals from end of surgery to extubation and discharge from intensive care unit. - Duration of the hospital stay from randomisation to the time of eligibility for discharge (postoperative length of stay). - Unplanned readmission rate at 3 months and 12 months for cardiovascular cause or haemorrhage. - Number of antiarrhythmic drugs and curative anticoagulation treatments within 3 months following cardiac surgery. - Total hospital cost: initial admission and readmissions for cardiovascular cause. - Incremental cost effectiveness ratio (additional cost per additional survival, additional QALY or per adverse event recognised).;Timepoint(s) of evaluation of this end point: at 3 months and 12 months	—

Measure

Time frame

Secondary end point(s): - Death rate at 12 months. - Rate of major adverse cardiovascular events at 3 months: conduction troubles such as atrioventricular block or the need for transient or permanent placement of a pacemaker, congestive heart failure, major bleeding, stroke and arterial thromboembolic events. - Adverse events (AE) and serious adverse events (SAE) by treatment group. - Incidence of atrial tachyarrhythmia including atrial fibrillation, but also atrial flutter and atrial tachycardia at 3 months, and each arrhythmia individually. - Incidence of new onset of postoperative AF depending on the following subgroups: age, gender, heart failure (defined by left ventricular ejection fraction 52 mL/m2) or LA diameter index > 48 mm/m2, EuroSCORE 2, eGFR < 60 mL/min / 1.73m2. - Intervals from end of surgery to extubation and discharge from intensive care unit. - Duration of the hospital stay from randomisation to the time of eligibility for discharge (postoperative length of stay). - Unplanned readmission rate at 3 months and 12 months for cardiovascular cause or haemorrhage. - Number of antiarrhythmic drugs and curative anticoagulation treatments within 3 months following cardiac surgery. - Total hospital cost: initial admission and readmissions for cardiovascular cause. - Incremental cost effectiveness ratio (additional cost per additional survival, additional QALY or per adverse event recognised).;Timepoint(s) of evaluation of this end point: at 3 months and 12 months

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Countries

France

Contacts

Public ContactDRCI Hôpital St Louis

ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)

josephine.braun@aphp.fr3301 44 84 17 38

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026