Prevention Atrial Fibrillation by BOTulinum Toxin Injections (BOTAF)

PHASE3RecruitingINTERVENTIONAL
Enrollment

220

Participants

Timeline

Start Date

September 30, 2019

Primary Completion Date

October 30, 2025

Study Completion Date

September 30, 2026

Conditions
Cardiac Surgery
Interventions
DRUG

Botulinum Toxin Type A Injection [Xeomin]

Before the main stage of the surgery, botulinum toxin will be injected into the entire visible area of the 4 major epicardial fat pads, during extra corporal circulation and before aortic cross clamping in order to reduce the time of ischemia.

OTHER

Drug placebo

All patients from the control group will receive placebo. Before the main stage of the surgery, during extra corporal circulation and before aortic cross clamping, the placebo will be injected into the entire visible area of the 4 major epicardial fat pads as follows (1 mL at each fat pad).

Trial Locations (9)

13008

ACTIVE_NOT_RECRUITING

Hôpital Saint-Joseph, Marseille

75014

RECRUITING

Institut Mutualiste Montsouris, Paris

75015

RECRUITING

Hôpital Européen Georges Pompidou, Paris

75877

WITHDRAWN

Hôpital Bichat, Paris

92200

ACTIVE_NOT_RECRUITING

Clinique Ambroise Paré, Neuilly-sur-Seine

93200

WITHDRAWN

Centre Cardiologique du Nord, Saint-Denis

Unknown

ACTIVE_NOT_RECRUITING

Corentin Celton, Issy-les-Moulineaux

ACTIVE_NOT_RECRUITING

Hôpital Marie Lannelongue, Le Plessis-Robinson

ACTIVE_NOT_RECRUITING

CHU Limoges, Limoges

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Merz Pharmaceuticals

INDUSTRY

collaborator

Ministry of Health, France

OTHER_GOV

lead

Assistance Publique - Hôpitaux de Paris

OTHER

NCT04075981 - Prevention Atrial Fibrillation by BOTulinum Toxin Injections (BOTAF) | Biotech Hunter | Biotech Hunter