FARAPULSE pulsed field ablation for paroxysmal atrial fibrillation

Real World Data Collection in Chinese Population Treated With the FARAPULSE™ Pulsed Field Ablation System

This study will try the FARAPULSE pulsed field ablation system in adults with paroxysmal atrial fibrillation in China and follow them for three years to collect real-world safety and effectiveness data.

Quick facts

• Study type: Observational
• Enrollment: 500 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Boston Scientific Corporation (Industry-sponsored)
• Locations: 1 site (Beijing, China/Beijing)
• Trial ID: NCT06762717 on ClinicalTrials.gov

What this trial studies

This is a prospective, non-randomized, single-arm, multi-center post-market observational study collecting real-world data on the FARAPULSE pulsed field ablation system when used per hospital standard of care. All consenting adults treated with the FARAPULSE system at participating centers will be enrolled and followed. Follow-up occurs pre-discharge, at 3 months, a 6-month phone call, a mandatory 12-month in-clinic visit, and at 24 and 36 months. The study focuses on gathering safety and effectiveness outcomes in the Chinese population under routine clinical conditions.

Who should consider this trial

Good fit: Adults (18+) with paroxysmal atrial fibrillation whom their physician intends to treat with the FARAPULSE system and who can provide informed consent and attend follow-up visits are ideal candidates.

Not a fit: Patients with atrial thrombus, recent myocardial infarction or stroke, active systemic infection, an interatrial patch, atrial myxoma, inability to obtain vascular access, intolerance to anticoagulation, or those under 18 are unlikely to be eligible or to benefit from participation.

Why it matters

Potential benefit: If successful, the results could support FARAPULSE as a safe and effective option for pulmonary vein isolation with potentially less collateral tissue injury than thermal ablation.

How similar studies have performed: Earlier clinical and post-market studies of pulsed field ablation, including prior FARAPULSE reports outside China, have shown promising safety and efficacy, though long-term real-world data in Chinese populations remain limited.

Eligibility criteria

Inclusion Criteria:

1. Subjects intended to be treated with the FARAPULSE™ Pulsed Field Ablation system for cardiac tissue ablation, per physician's medical judgement, and as per hospitals' standard of care
2. Subjects who are willing and capable of providing informed consent
3. Subjects who are willing and capable of participating in all testing associated with this clinical study at an approved clinical investigational center
4. Subjects whose age is 18 years or above.

Exclusion Criteria:

1. Subjects with a current interatrial baffle or patch
2. Subjects with a known or suspected atrial myxoma
3. Subjects with a myocardial infarction within 14 days prior to enrollment
4. Subjects with a recent (within 30 days prior to enrollment) Cerebral Vascular Accident (CVA)
5. Subjects who do not tolerate anticoagulation therapy
6. Subjects with an active systemic infection \*
7. Subjects with a presence of atrial known thrombus \*
8. Subjects with a known inability to obtain vascular access
9. Subjects who are pregnant or planning to be pregnant
10. Subjects with atrial fibrillation that is secondary to electrolyte imbalance, thyroid disease, alcohol, or other reversible / non-cardiac causes
11. Subjects with any prosthetic heart valve, ring or repair including balloon aortic valvuloplasty
12. Subjects with a contraindication to an invasive electrophysiology procedure where insertion or manipulation of a catheter in the cardiac chambers is deemed unsafe per physician's medical judgement, such as, but not limited to, a recent previous cardiac surgery (e.g., ventriculotomy or atriotomy, CABG, PTCA/PCI/coronary stent procedure), recent previous unstable angina and/or in patients with congenital heart disease where the underlying abnormality increases the risk of the ablation (e.g., severe rotational anomalies of the heart or great vessels)
13. Subjects with a life expectancy of ≤ 1 year per investigator's opinion
14. Subjects who are currently enrolled in another investigational study or registry that would directly interfere with the current study, except when the subject is participating in a mandatory governmental registry, or a purely observational registry with no associated treatments. Each instance must be brought to the attention of the sponsor to determine eligibility.

Where this trial is running

Beijing, China/Beijing

• Fuwai Hospital, Chinese Academy of Medical Sciences — Beijing, China/Beijing, China (Recruiting)

Study contacts

• Principal investigator: Min Tang, Dr — Chinese Academy of Medical Sciences, Fuwai Hospital
• Study coordinator: Hui Lin

Conditions Paroxysmal AF