Pulmonary Vein Isolation Alone or in Combination With Substrate Modulation After Electric Cardioversion Failure

NARecruitingINTERVENTIONAL
Enrollment

450

Participants

Timeline

Start Date

February 20, 2023

Primary Completion Date

April 1, 2025

Study Completion Date

October 1, 2027

Conditions
Persistent Atrial Fibrillation
Interventions
PROCEDURE

Pulmonary Vein Isolation (PVI) alone

PVI procedures correspond to point-by-point 50W AI-guided RF applications (400 posterior LA wall, and 550 elsewhere). The PVI will be validated by the absence of any activity recorded inside the PV encirclement by a multipolar catheter (either a Lasso catheter or a Pentaray catheter) (entrance block) and by the non-capture of the LA despite pacing maneuvers from inside the encirclement (exit block). The bidirectional block will be validated again after a 15-minutes waiting period.

PROCEDURE

PVI procedure associated with substrate modulation

PVI procedure associated with substrate modulation

Trial Locations (13)

30000

RECRUITING

Hôpital Privé Les Franciscaines, Nîmes

31076

RECRUITING

Clinique Pasteur Service de cardiologie/rythmologie, Toulouse

33500

NOT_YET_RECRUITING

CH Libourne, Libourne

35033

RECRUITING

CHU Rennes, Rennes

54500

NOT_YET_RECRUITING

Chu Nancy, Vandœuvre-lès-Nancy

59000

ACTIVE_NOT_RECRUITING

CHU Lille, Lille

59462

NOT_YET_RECRUITING

Hopital ST Phillbert, Lomme

66000

RECRUITING

Clinique St Pierre Cardiologie, Perpignan

67000

NOT_YET_RECRUITING

Clinique Rhéna, Strasbourg

69300

RECRUITING

Infirmerie Protestante, Caluire-et-Cuire

75015

RECRUITING

Hôpital Européen Georges Pompidou Service de cardiologie - Unité rythmologie, Paris

92200

NOT_YET_RECRUITING

CMC Ambroise Paré Hartmann, Neuilly-sur-Seine

93200

NOT_YET_RECRUITING

CCN, Saint-Denis

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Elsan

OTHER

NCT05264831 - Pulmonary Vein Isolation Alone or in Combination With Substrate Modulation After Electric Cardioversion Failure | Biotech Hunter | Biotech Hunter