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RECRUITING
NCT05264831
NA

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

Sponsor: Elsan

View on ClinicalTrials.gov

Summary

This study aims at assessing whether electric cardioversion can act as a discriminant factor between patients requiring Pulmonary Vein Isolation (PVI) procedure alone or PVI procedure combined with substrate modulation. All included patients will undergo an electric cardioversion, then: * Patients with electric cardioversion success will be treated as per Standard of Care and according to ESC recommendations (2020). A prospective registry will be implemented for these patients. * Patients with electric cardioversion failure will be randomized in the study between 2 ablative procedures: * PVI procedure alone * PVI procedure combined with substrate modulation

Official title: Pulmonary Vein Isolation Alone or in Combination With Substrate Modulation After Electric Cardioversion Failure in Patients With Persistent Atrial Fibrillation: a Randomized, Multicentric, and Comparative Study

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

450

Start Date

2023-02-20

Completion Date

2027-10-01

Last Updated

2024-04-24

Healthy Volunteers

No

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

Locations (13)

Infirmerie Protestante

Caluire-et-Cuire, France

CH Libourne

Libourne, France

CHU Lille

Lille, France

Hopital ST Phillbert

Lomme, France

CMC Ambroise Paré Hartmann

Neuilly-sur-Seine, France

Hôpital Privé Les Franciscaines

Nîmes, France

Hôpital Européen Georges Pompidou Service de cardiologie - Unité rythmologie

Paris, France

Clinique St Pierre Cardiologie

Perpignan, France

CHU Rennes

Rennes, France

CCN

Saint-Denis, France

Clinique Rhéna

Strasbourg, France

Clinique Pasteur Service de cardiologie/rythmologie

Toulouse, France

Chu Nancy

Vandœuvre-lès-Nancy, France