FARAPULSE™ Pulsed Field Ablation System

Last updated: May 28, 2026
Sponsor: Boston Scientific Corporation
Overall Status: Active - Recruiting

Phase

N/A

Condition

Dysrhythmia

Arrhythmia

Chest Pain

Treatment

FARAPULSE™ Pulsed Field Ablation system

Clinical Study ID

NCT06762717
PF333
  • Ages > 18
  • All Genders

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 Criteria

Inclusion

Inclusion Criteria:

  1. Subjects intended to be treated with the FARAPULSE™ Pulsed Field Ablation system forcardiac 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 withthis clinical study at an approved clinical investigational center

  4. Subjects whose age is 18 years or above.

Exclusion

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 VascularAccident (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 aorticvalvuloplasty

  12. Subjects with a contraindication to an invasive electrophysiology procedure whereinsertion or manipulation of a catheter in the cardiac chambers is deemed unsafe perphysician's medical judgement, such as, but not limited to, a recent previouscardiac surgery (e.g., ventriculotomy or atriotomy, CABG, PTCA/PCI/coronary stentprocedure), recent previous unstable angina and/or in patients with congenital heartdisease 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 registrythat would directly interfere with the current study, except when the subject isparticipating in a mandatory governmental registry, or a purely observationalregistry with no associated treatments. Each instance must be brought to theattention of the sponsor to determine eligibility.

Study Design

Total Participants: 500
Treatment Group(s): 1
Primary Treatment: FARAPULSE™ Pulsed Field Ablation system
Phase:
Study Start date:
October 23, 2025
Estimated Completion Date:
December 31, 2029

Study 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).

Connect with a study center

  • Fuwai Hospital, Chinese Academy of Medical Sciences

    Beijing, China/Beijing 100037
    China

    Active - Recruiting

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