Comparing two procedures for treating persistent atrial fibrillation after failed electric cardioversion

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

This study is testing which of two procedures works better for patients with persistent atrial fibrillation who haven't had success with electric cardioversion.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 450 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Elsan (Academic / other)
• Locations: 13 sites (Caluire-et-Cuire and 12 other locations)
• Trial ID: NCT05264831 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness of two different approaches for patients with persistent atrial fibrillation who do not respond to electric cardioversion. After undergoing electric cardioversion, patients who fail this treatment will be randomized to receive either pulmonary vein isolation alone or pulmonary vein isolation combined with substrate modulation. The goal is to determine which approach yields better outcomes for patients with this common heart rhythm disorder. The study aims to improve treatment strategies and patient care for those suffering from persistent atrial fibrillation.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 80 with persistent atrial fibrillation that is symptomatic and resistant to at least one anti-arrhythmic drug.

Not a fit: Patients who do not have persistent atrial fibrillation or those with a life expectancy of less than 5 years may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved treatment options and outcomes for patients with persistent atrial fibrillation.

How similar studies have performed: Previous studies have shown that combining pulmonary vein isolation with substrate modulation can improve outcomes for patients with persistent atrial fibrillation, suggesting this approach has potential for success.

Eligibility criteria

Inclusion criteria:

Criteria to be validated for patients included before performing electric cardioversion:

1\) 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 :

1. 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:
2. Life expectancy \> 5 years;
3. Female or male between 18 and 80 years of age at the electric cardioversion time
4. Affiliation to a health insurance system;
5. 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):
6. 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):

1. Current hyperthyroidism;
2. Pregnant or breastfeeding woman;
3. Patient with a Body Mass Index (BMI) greater than 35;
4. Patient with severe Chronic Obstructive Pulmonary Disease (COPD);
5. Patient with hypertrophic heart disease;
6. Patient with a mechanical or biological mitral valve;
7. Contraindications to anticoagulants;
8. Transient Ischemic Attack (TIA) /stroke less than 6 months old;
9. Psychiatric illness affecting follow-up;
10. Left Ventricular Ejection Fraction (LVEF) \< 40% ;
11. Uncontrolled ischaemic heart disease (angina, myocardial ischaemia)
12. Patients under legal protection
13. Cardiac surgery on left atrium
14. Inflammatory status in progress (cancer, rheumatoid arthritis, PPRZ, acute or chronic periodontitis, Crohn's disease, RCUH)
15. Pulmonary embolism or phlebitis less than 6 months old
16. Prior atrial fibrillation ablation
17. Active cancer

    Criteria to be validated before randomization, on the day of ablation (these patients cannot be randomized):
18. Patient in sinus rhythm 4-6 weeks after electric cardioversion: these patients are included in the study registry.
19. Patient with complete absence of sinus rhythm (less than 10 seconds) after 3 electric cardioversion attempts: these patients will discontinue from the study.

Where this trial is running

Caluire-et-Cuire and 12 other locations

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

Study contacts

• Study coordinator: Agustín Bortone, MD

Conditions Persistent Atrial Fibrillation