CLOSTRIDIUM BOTULINUM NEUROTOXIN TYPE A (150KD), FREE OF COMPLEXING PROTEINS for Postoperative atrial fibrillation | Atrial fibrillation

Inclusion criteria

• {"criterion_text":"-\tIndication 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.\n-\tPatients in hemodynamically stable condition.\n-\tSinus rhythm at moment of randomisation (ECG).\n-\tAge: ≥18 to ≤80 years old.\n-\tNegative serum or urinary β-hCG for women of child-bearing potential.\n-\tPatients able to attend several consultations at the centre.\n-\tInformed consent signed.\n-\tAffiliation to French social security regime."}

Exclusion criteria

• {"criterion_text":"-\tPrevious cardiac surgery.\n-\tPersistent AF or atrial tachycardia.\n-\tPlanned maze procedure or pulmonary vein (PV) isolation.\n-\tUse of class I or III antiarrhythmic drugs within 5 elimination half-life of the drug (for amiodarone: one year).\n-\tMitral or tricuspid valve surgery.\n-\tCongenital cardiomyopathy.\n-\tNeuro-muscular disease including disorders of pre-operative swallowing\n-\tProtected populations e.g. minor patient, breastfeeding women, patients under legal guardianship, curatorship or legal protection.\n-\tParticipation in another interventional trial.\n-\tUnwillingness to participate.\n-\tContraindications to botulinum toxin under investigation or to the excipients: known hypersensitivity.\n-\tPatient with active endocarditis.\n-\tMinimal invasive surgery (ministernotomy)."}

Primary endpoints

• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Defined as atrial arrhythmia during at least 30 seconds continuously within 21 days after cardiac surgery; measured by Holter ECG Spiderflash-t recorder during the first 21 days post-op and daily ECG monitoring during the first 7 days after surgery; adjudicated independently by two blinded cardiologists."}

France

Earliest CTIS Part Ii Submission Date

07-06-2024

Latest Decision Or Authorization Date

19-11-2024

Processing Time Days

165

Number Of Sites

7

Number Of Participants

220

Primary sponsor

Full Name

Assistance Publique Hopitaux De Paris

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France

Third parties

• {"country":"","full_name":"French Ministry of Health","duties_or_roles":"Source of monetary support","organisation_type":""}
• {"country":"","full_name":"Merz Pharma","duties_or_roles":"Source of monetary support / commercial partner (listed as monetary support in trial record)","organisation_type":""}