FARAPULSE™ Pulsed Field Ablation System

NCT06762717 | Recruiting FDA Device

• 1 other identifier: PF333
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Paroxysmal AF

Outcome Measures

Primary Outcomes (3)

• 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

Interventions

FARAPULSE™ Pulsed Field Ablation system DEVICE

no intervention design in the study

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (1)

Fuwai Hospital, Chinese Academy of Medical Sciences

Beijing, China/Beijing, 100037, China

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Min Tang, Dr

  Chinese Academy of Medical Sciences, Fuwai Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hui Lin

CONTACT

15810430945; Hui.Lin@bsci.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2025
• First Posted: January 8, 2025
• Study Start: October 23, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2029
• Last Updated: April 27, 2026

Record last verified: 2026-04

Locations

CN (1)