NCT06985901 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
| NCT ID | NCT06985901 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Centre Hospitalier Universitaire de Nice |
| Condition | Persistent Atrial Fibrillation |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2026-04-13 |
| Primary Completion | 2028-04-13 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2026-04-13 with a primary completion date of 2028-04-13.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 pulmonary vein isolation \[PVI\]) is a validated therapeutic option for persistent AF. Recently, Pulsed-field ablation (PFA) - a new non-thermal energy - has been used to treat paroxysmal and persistent AF with a high success rate in observational studies. This new technology is based on tissue-specificity on myocardium, avoiding collateral damages on adjacent structures. Before confirming a superiority of PFA over existing thermal energies, prospective studies concerning an exclusive population of persistent AF patients are needed, with rigorous assessment of the recurrences using continuous monitoring (insertable cardiac monitor \[ICM\]). PFA efficacy using ICM has never been evaluated. Before considering PFA in therapeutic strategies through large-scale randomized studies using rigorous monitoring of recurrences, preliminary studies are needed in a persistent AF population-only. This pilot cohort study will provide solid data of PFA efficacy (using continuous monitoring of recurrences) for future randomized studies.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06985901 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Persistent Atrial Fibrillation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06985901 currently recruiting?
Yes, NCT06985901 is actively recruiting participants. Contact the research team at bun.s@chu-nice.fr for enrollment information.
Where is the NCT06985901 trial being conducted?
This trial is being conducted at Nice, France.
Who is sponsoring the NCT06985901 clinical trial?
NCT06985901 is sponsored by Centre Hospitalier Universitaire de Nice. The trial plans to enroll 60 participants.
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