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

Launched by CENTRE HOSPITALIER UNIVERSITAIRE DE NICE · May 21, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment method for persistent atrial fibrillation (AF), which is a common heart rhythm problem that lasts longer than seven days. The study will evaluate the effectiveness of a technique called pulsed-field ablation (PFA), which uses non-thermal energy to target heart tissue without damaging surrounding areas. This method is being tested because it may work better than traditional treatments, and participants will be monitored closely with a small device that continuously tracks their heart activity.

To be eligible for the trial, participants need to have persistent AF that is causing symptoms and have not found relief from standard treatments or are unable to take them. They must also be between the ages of 65 and 74 and provide informed consent. This study is not currently recruiting participants, but it aims to gather important information that could lead to larger studies in the future. If you or someone you know fits these criteria and is interested in learning more, it's worth discussing with a healthcare provider.

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ALL

Eligibility criteria

• 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