NCT06762717 FARAPULSE™ Pulsed Field Ablation System
| NCT ID | NCT06762717 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Boston Scientific Corporation |
| Condition | Paroxysmal AF |
| Study Type | OBSERVATIONAL |
| Enrollment | 500 participants |
| Start Date | 2025-10-23 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 500 participants in total. It began in 2025-10-23 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Min Tang, Dr
PRINCIPAL INVESTIGATOR
Chinese Academy of Medical Sciences, Fuwai Hospital
Frequently Asked Questions
Who can join the NCT06762717 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Paroxysmal AF. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06762717 currently recruiting?
Yes, NCT06762717 is actively recruiting participants. Contact the research team at Hui.Lin@bsci.com for enrollment information.
Where is the NCT06762717 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT06762717 clinical trial?
NCT06762717 is sponsored by Boston Scientific Corporation. The principal investigator is Min Tang, Dr at Chinese Academy of Medical Sciences, Fuwai Hospital. The trial plans to enroll 500 participants.