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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorElsan

About this trial

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 criteria

Qualifiers

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

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;

Disqualifiers

Current hyperthyroidism;

Pregnant or breastfeeding woman;

Patient with a Body Mass Index (BMI) greater than 35;

Patient with severe Chronic Obstructive Pulmonary Disease (COPD);

Trial design

Treatments tested in this trial

  • Pulmonary Vein Isolation (PVI) alone
  • PVI procedure associated with substrate modulation

Treatment groups

450 Participants
are divided into 2 treatment groups

Sponsors and collaborators