Status:
NOT_YET_RECRUITING
Evaluation of the Efficacy of Pulmonary Vein Isolation by Pulsed-field Ablation in Persistent Atrial Fibrillation: a Multicenter Study With Follow-up by Implantable Cardiac Monitor
Lead Sponsor:
Centre Hospitalier Universitaire de Nice
Conditions:
Persistent Atrial Fibrillation
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Atrial fibrillation (AF) is the most common sustained arrhythmia in adult population. According to current guidelines for the management of AF, radiofrequency (RF) ablation (including at least pulmona...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Symptomatic persistent AF (continuous episode sustained beyond 7 days)
- Refractory, intolerant or unwilling to take ADT
- Signed informed consent
- Affiliation to medical social coverage.
- Non inclusion Criteria:
- Persistent long-term atrial fibrillation with ongoing episode continuous for more than 3 years;
- Left ventricular ejection fraction ≤ 15% ;
- Stage IV of the New York Heart Association classification;
- Previous atrial ablation outside the cavotricuspid isthmus;
- Wearer of an implantable electronic cardiac prosthesis (pacemaker or defibrillator; MCI)
- Hypertrophic heart disease other than hypertensive hypertrophic heart disease;
- Severe valvular heart disease, including the presence of a mechanical mitral valve or any mitral surgery;
- Congenital heart disease, including atrial septal defect, patent foramen ovale treated by percutaneous closure with atrial septal prosthesis;
- Presence of cardiac thrombus;
- Myocardial infarction or percutaneous coronary angioplasty within the last 6 months;
- Cardiac surgery within the last 6 months;
- Systemic thromboembolic event less than 6 months ago;
- Pulmonary embolism less than 6 months ago or pulmonary hypertension requiring specific treatment;
- Inability to read independently
- Vulnerable patient: minor, patient under curatorship or guardianship
Exclusion
Key Trial Info
Start Date :
March 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2029
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06985901
Start Date
March 1 2026
End Date
December 1 2029
Last Update
December 16 2025
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