CClinicalTrials.gg
Active, not recruitingNCT06762717Updated Sep 25, 2026

FARAPULSE™ Pulsed Field Ablation System

An observational study in Paroxysmal AF, sponsored by Boston Scientific Corporation. Active, not recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-25.

Sponsored by Boston Scientific Corporation · Observational

Updated Sep 25, 2026Now Active, not recruitingEnrollment updatedGo to Updates ↓
Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
501
Ages
18 Years and older
Sex
All
01

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.

Read the 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).

02

Conditions studied

  • Paroxysmal AF

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03

In context

Atrial Fibrillation

3,870 studies on the registry are indexed under Atrial Fibrillation; 924 are open to participants now.

This study's enrollment of 501 is above the median of 300 across 1,363 observational studies indexed under Atrial Fibrillation.

Browse Atrial Fibrillation studies →

Lead sponsor

Boston Scientific Corporation is the lead sponsor of 517 studies on the registry; 38 are open to participants now.

Of its 64 completed or terminated interventional studies of FDA-regulated products, 56 (88%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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

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

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.
05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
501 participants (actual)
Patient registry
No

Interventions

  • DeviceFARAPULSE™ Pulsed Field Ablation system

    no intervention design in the study

06

What researchers measure

Primary outcomes

  1. Failure-free rate

    Failure-free rate at 12 Month post index procedure.

    Time frame: 12 Months

  2. Device-or procedure-related SAEs:

    Composite of the following device- or procedure-related SAEs:

    Time frame: 7 days and 12 months

  3. 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.

    Time frame: 12 Months and 2 years and 3 years

07

Study locations

1 site
  • Fuwai Hospital, Chinese Academy of Medical Sciences
    Beijing, China/Beijing 100037, China
08

Updates

1 registry update since Sep 25, 2026
Status
Recruiting→Active, not recruiting
changed Sep 25, 2026
Enrollment
500 (estimated)→501 (actual)
Sep 25, 2026
Show all 1 update
  1. Sep 25, 2026
    Recruiting→Active, not recruiting
    Enrollment 500 (estimated)→501 (actual)
    + 3 other changes: verification date, contact details and site details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT06762717
Lead sponsor
Boston Scientific Corporation
Responsible party
Sponsor
First posted
Jan 8, 2025
Start date
Oct 23, 2025
Primary completion
Dec 31, 2027 (estimated)
Completion
Dec 31, 2029 (estimated)
Last update
Sep 25, 2026

Study contacts

Min Tang, Dr
principal investigator · Chinese Academy of Medical Sciences, Fuwai Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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