RecruitingNot ApplicableNCT05264831

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

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


Sponsor

Elsan

Enrollment

450 participants

Start Date

Feb 20, 2023

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two types of ablation (a procedure that uses energy to destroy heart tissue) for people with persistent atrial fibrillation (an irregular heartbeat that has lasted more than 7 days). One approach targets just the pulmonary veins; the other also targets additional abnormal areas in the heart. **You may be eligible if...** - You are between 18 and 80 years old - You have persistent atrial fibrillation that has lasted at least 7 days without stopping - Your irregular heartbeat is causing symptoms and has not responded to at least one anti-arrhythmic drug (including amiodarone) - You have recently had an electrical cardioversion procedure (or are about to have ablation planned) - Your life expectancy is greater than 5 years **You may NOT be eligible if...** - You have severe heart valve disease, severe heart failure, or other serious heart conditions - A blood clot is found in your heart before the procedure - You have had a prior ablation procedure for atrial fibrillation - You are pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREPulmonary 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.

PROCEDUREPVI 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

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NCT05264831


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