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NCT06762717Active, not recruiting

FARAPULSE™ Pulsed Field Ablation System

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

Source: ClinicalTrials.gov · Last updated 27 Oct 2026

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Study type
Observational
Enrollment
501 (actual)
First submitted
6 Jan 2025
Start date
23 Oct 2025
Primary completion date
31 Dec 2027
Lead sponsor
Boston Scientific Corporation
NCT number
NCT06762717

What you commit to

  • Study type: Observational
  • Participants enrolled: 501
  • From 23 Oct 2025 to the primary completion date, 31 Dec 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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 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)

Other illness

  • Subjects with an active systemic infection \*
  • 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

Other

  • Subjects with a current interatrial baffle or patch
  • Subjects with a known or suspected atrial myxoma
  • 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 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.

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: All

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Fuwai Hospital Chinese Academy of Medical Sciences
Coordinator of this site? Confirm its status
BeijingChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.