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
This trial does not accept healthy volunteersQualifiers
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
Parallel
Treatments tested in this trial
Pulmonary Vein Isolation (PVI) alone
Procedure/SurgeryPVI 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.
PVI procedure associated with substrate modulation
Procedure/SurgeryPVI procedure associated with substrate modulation
Treatment groups
Trial outcomes
Primary outcomes
1-year sinus rhythm maintenance rate
Rate of patients with sinus rhythm (yes/no) at 1 year after a single ablative procedure
Secondary outcomes
Rate of patients with sinus rhythm (randomized patients)
Rate of patients with sinus rhythm during 1 year after ablation and after a single ablative procedure.
Rate of patients with sinus rhythm (registry patients)
Rate of patients with sinus rhythm during 1 year after ablation and after a single ablative procedure.
Rate of patients with sinus rhythm (randomized and registry patients, strategy PVI procedure alone)
Rate of patients with sinus rhythm during 1 year after ablation and after a single ablative procedure.
Duration (in minutes) of ablative procedure
Duration (in minutes) of ablative procedure