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Clinical Trials in China / NCT06762717
Recruiting Observational

FARAPULSE™ Pulsed Field Ablation System

NCT06762717 · tracked via the Priya Life Science China tracker
Sponsor
Boston Scientific Corporation
Phase
Observational
Started
2025-10-23
Last updated
2026-08-27

Condition(s) studied

Paroxysmal AF

Investigational drug(s) / intervention(s)

FARAPULSE™ Pulsed Field Ablation system

FARAPULSE™ Pulsed Field Ablation system: no intervention design in the study

Study 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

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Fuwai Hospital, Chinese Academy of Medical Sciences Beijing China/Beijing Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06762717 on ClinicalTrials.gov ↗ ← All trials in China