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

Recruiting now · Not applicable

Conditions studied: Persistent Atrial Fibrillation

In brief

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

Key facts

Study ID

NCT05264831

Run by

Elsan

People needed

450

Starts

2023-02-20

Expected to finish

2027-10-01

Last updated by the study team

2024-04-24

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Criteria to be validated for patients included before performing electric cardioversion:
• Persistent AF (continuous for at least 7 days without interruption according to information transmitted by the cardiologist and the patient), symptomatic and resistant to at leat one anti-arrhythmic drug treatment including amiodarone;
• Criteria to be validated for patients included after performing electric cardioversion :
• Patient treated by electric cardioversion for persistent AF, symptomatic and resistant to anti-arrhythmic treatment including amiodarone and whom ablative procedure is planned in the following 4-6 weeks after electric cardioversion
• Criteria to be validated for all patients included:
• Life expectancy > 5 years;
• Female or male between 18 and 80 years of age at the electric cardioversion time
• Affiliation to a health insurance system;
• Patient informed of the study and having signed informed consent
• Criteria to be validated prior to randomization on the day of ablation (these patients may be randomized):
• Patient with failed electric cardioversion i.e. in AF, confirmed by ECG.

You may not qualify if…

• Criteria to be validated before or after performing electric cardioversion (the study cannot be proposed to patients corresponding to these criteria):
• Current hyperthyroidism;
• Pregnant or breastfeeding woman;
• Patient with a Body Mass Index (BMI) greater than 35;
• Patient with severe Chronic Obstructive Pulmonary Disease (COPD);
• Patient with hypertrophic heart disease;
• Patient with a mechanical or biological mitral valve;
• Contraindications to anticoagulants;
• Transient Ischemic Attack (TIA) /stroke less than 6 months old;
• Psychiatric illness affecting follow-up;
• Left Ventricular Ejection Fraction (LVEF) < 40% ;
• Uncontrolled ischaemic heart disease (angina, myocardial ischaemia)
• Patients under legal protection
• Cardiac surgery on left atrium
• Inflammatory status in progress (cancer, rheumatoid arthritis, PPRZ, acute or chronic periodontitis, Crohn's disease, RCUH)
• Pulmonary embolism or phlebitis less than 6 months old
• Prior atrial fibrillation ablation
• Active cancer
• Criteria to be validated before randomization, on the day of ablation (these patients cannot be randomized):
• Patient in sinus rhythm 4-6 weeks after electric cardioversion: these patients are included in the study registry.
• Patient with complete absence of sinus rhythm (less than 10 seconds) after 3 electric cardioversion attempts: these patients will discontinue from the study.

Where it is running

• Infirmerie Protestante — Caluire-et-Cuire, France (enrolling)
• Hôpital Privé Les Franciscaines — Nîmes, France (enrolling)
• Hôpital Européen Georges Pompidou Service de cardiologie - Unité rythmologie — Paris, France (enrolling)
• Clinique St Pierre Cardiologie — Perpignan, France (enrolling)
• CHU Rennes — Rennes, France (enrolling)
• Clinique Pasteur Service de cardiologie/rythmologie — Toulouse, France (enrolling)
• CCN — Saint-Denis, France
• Clinique Rhéna — Strasbourg, France
• CH Libourne — Libourne, France
• CHU Lille — Lille, France
• Hopital ST Phillbert — Lomme, France
• CMC Ambroise Paré Hartmann — Neuilly-sur-Seine, France
• Chu Nancy — Vandœuvre-lès-Nancy, France

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.