Pulmonary Vein Isolation Alone or in Combination With Substrate Modulation After Electric Cardioversion Failure
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
Elsan
450 participants
Feb 20, 2023
INTERVENTIONAL
Conditions
Summary
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
Inclusion Criteria11
- 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 Criteria21
- 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.
Interventions
PVI 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
Locations(13)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05264831