RecruitingNCT06762717

FARAPULSE™ Pulsed Field Ablation System

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

Sponsor

Boston Scientific Corporation

Enrollment

500 participants

Start Date

Oct 23, 2025

Study Type

OBSERVATIONAL

Conditions

Paroxysmal AF

Summary

To obtain real world data on the use of, and provide continued evidence on safety and effectiveness of the FARAPULSE™ Pulsed Field Ablation (PFA) system when used per hospitals' standard of care in Chinese population.

Eligibility

Min Age: 18 Years

Inclusion Criteria4

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
Subjects who are willing and capable of providing informed consent
Subjects who are willing and capable of participating in all testing associated with this clinical study at an approved clinical investigational center
Subjects whose age is 18 years or above.

Exclusion Criteria14

Subjects with a current interatrial baffle or patch
Subjects with a known or suspected atrial myxoma
Subjects with a myocardial infarction within 14 days prior to enrollment
Subjects with a recent (within 30 days prior to enrollment) Cerebral Vascular Accident (CVA)
Subjects who do not tolerate anticoagulation therapy
Subjects with an active systemic infection \*
Subjects with a presence of atrial known thrombus \*
Subjects with a known inability to obtain vascular access
Subjects who are pregnant or planning to be pregnant
Subjects with atrial fibrillation that is secondary to electrolyte imbalance, thyroid disease, alcohol, or other reversible / non-cardiac causes
Subjects with any prosthetic heart valve, ring or repair including balloon aortic valvuloplasty
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)
Subjects with a life expectancy of ≤ 1 year per investigator's opinion
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.