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Pulmonary Vein Isolation Alone or in Combination With Substrate Modulation After Electric Cardioversion Failure
Sponsor: Elsan
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
Conditions
Interventions
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.
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