FARAPULSE™ Pulsed Field Ablation System

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

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.

Study Overview

• Status: Recruiting
• Conditions: Paroxysmal AF
• Intervention / Treatment: Device: FARAPULSE™ Pulsed Field Ablation system

Detailed Description

The study is an observational, prospective, non-randomized, single-arm, multi-center post-market study.

All subjects signing the informed consent form, will be included in the study. All subjects treated with the FARAPULSE™ PFA system will be followed for three years.

Subjects will undergo the index procedure per hospitals' standard of care after enrollment, and followed at pre-discharge, 3 Month, 6 Month (Phone call only), 12 Month (in-clinic visit mandatory), 24 Month (2 Year) and 36 Month (3 Year).

• Study Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

• Study Contact: Name: Hui Lin; Phone Number: 15810430945; Email: Hui.Lin@bsci.com

Study Locations

• China
  • China/Beijing
    • Beijing, China/Beijing, China, 100037
      • Recruiting
      • Fuwai Hospital, Chinese Academy of Medical Sciences
      • Contact: Min Tang, Dr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Subjects enrolled in the FARADISE study will be clinically indicated for an ablation procedure with the FARAPULSE™ Pulsed Field Ablation system, per indication approved in China, per physician's medical judgement, and according to hospitals' standard of care

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Failure-free rate	Failure-free rate at 12 Month post index procedure.	12 Months
Device-or procedure-related SAEs:	Composite of the following device- or procedure-related SAEs:	7 days and 12 months
Procedure- and device related adverse events	All FARAPULSE™ PFA procedure- and device related adverse events at 12 Month, 2 Year and 3 Year follow-up.	12 Months and 2 years and 3 years

Collaborators and Investigators

• Sponsor: Boston Scientific Corporation
• Investigators: Principal Investigator: Min Tang, Dr, Chinese Academy of Medical Sciences, Fuwai Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 23, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2029

Study Registration Dates

• First Submitted: January 6, 2025
• First Submitted That Met QC Criteria: January 6, 2025
• First Posted (Actual): January 8, 2025

Study Record Updates

• Last Update Posted (Actual): May 29, 2026
• Last Update Submitted That Met QC Criteria: May 28, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Pathological Conditions, Signs and Symptoms; Atrial Fibrillation
• Other Study ID Numbers: PF333

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes