Pulmonary Vein Isolation Alone or in Combination With Substrate Modulation After Electric Cardioversion Failure
Recruiting · NCT05264831 · Interventional (participants receive a specific treatment) · Lead sponsor: Elsan
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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
Who can take part
Inclusion criteria
- 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.
Exclusion criteria
- 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
13 locations listed.
- 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