Prospective Multicenter Randomized and Controlled Study Evaluating the Benefit of Early Pulmonary Vein Isolation Compared to Usual Treatment in Patients Aged Over 75 Years and Presenting With Atrial Fibrillation

NARecruitingINTERVENTIONAL
Enrollment

294

Participants

Timeline

Start Date

April 9, 2024

Primary Completion Date

April 9, 2030

Study Completion Date

April 9, 2030

Conditions
Atrial Fibrillation
Interventions
PROCEDURE

Rhythm control by Pulmonary Vein Isolation (PVI) procedure

"The PVI procedure involves the creation of a circumferential lesion around the ostium of the four pulmonary veins.~The choice of the type of energy to insure the lesion will be left to the discretion of the investigator, according to the center's habits and the patient's anatomy found on the scanner."

DRUG

Conventional care by antiarrhythmic drugs (flecainide, sotalol, amiodarone) or bradycardic drugs (all betablocker or calcium channel blocker therapy, digoxin)

"Ventricular rate control is carried out using negative chronotropic agents (e.g. beta-blockers, calcium channel blockers, digitalis, etc.) according to current recommendations. If this fails, ablation of the atrioventricular junction with placement of a permanent pacemaker can be carried out according to current recommendations. As part of this research, the choice of bradycardic drugs and interventions will be left to the discretion of the investigator according to the center's practices and current recommendations.~Rhythm control aims to reduce AF by cardioversion (if it persists) to restore sinus rhythm and subsequently maintain it by introducing anti-arrhythmic treatment. Several antiarrhythmic drugs (flecainide, sotalol or amiodarone) can be used in this setting. As part of this research, the choice of antiarrhythmic drugs will be left to the discretion of the investigator according to the center's practices and current recommendations."

Trial Locations (1)

44093

RECRUITING

Nantes University Hospital, Nantes

All Listed Sponsors
lead

Nantes University Hospital

OTHER