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Combining heart procedures for atrial fibrillation and left atrial appendage closure

cOncomitant Left Atrial aPpendage Closure and Pulsed Field ablaTION-Asia

Observational Boston Scientific Corporation · NCT06686485

This study is testing if using a new heart procedure for atrial fibrillation together with a device that closes a heart pouch can be safe and effective for patients needing both treatments.

Quick facts

Study typeObservational
Enrollment433 (estimated)
Ages18 Years and up
SexAll
SponsorBoston Scientific Corporation Industry-sponsored
Locations34 sites (Suzhou, Jiangsu and 33 other locations)
Trial IDNCT06686485 on ClinicalTrials.gov

What this trial studies

The OPTION-A study is an observational, prospective, single-arm, multi-center study that evaluates the safety and effectiveness of using the FARAPULSE™ Pulsed Field Ablation (PFA) system alongside the WATCHMAN™ Left Atrial Appendage Closure (LAAC) device in patients undergoing treatment for atrial fibrillation. Participants will be selected based on clinical indications for both procedures, as determined by their physicians. The study aims to gather data on the outcomes of these concomitant procedures performed during the same intervention.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older who require both atrial fibrillation ablation and left atrial appendage closure as per their physician's assessment.

Not a fit: Patients who have previously undergone atrial fibrillation ablation or have conditions that preclude the use of the WATCHMAN device will not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could improve treatment outcomes for patients with atrial fibrillation by effectively managing both the arrhythmia and the risk of stroke.

How similar studies have performed: While this study utilizes established devices, the specific combination of these procedures in an observational setting is relatively novel and has not been extensively tested in prior studies.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Clinically indicated for treatment with both the FARAPULSE™ PFA system and with WATCHMAN for LAAC, per physician medical judgement and as per hospitals' standard of care.
2. Subjects who are willing and able to provide informed consent.
3. Subjects who are willing and able to participate in all testing associated with this clinical study at an approved clinical investigational center.
4. Subjects whose age is 18 years or above, or who are of legal age to give informed consent specific to state and national law.

Exclusion Criteria:

1. Subjects who underwent prior AF ablation procedure.
2. Subjects with atrial fibrillation that is secondary to electrolyte imbalance, thyroid disease, alcohol, or other reversible / non-cardiac causes.
3. Already surgically closed or otherwise excluded LAA.
4. The LAA anatomy does not accommodate a Closure Device.
5. Known or suspected atrial myxoma.
6. Presence of intracardiac thrombus.
7. Subjects with a current interatrial baffle or patch, history of atrial septal repair or has an ASD/PFO device.
8. Subjects with a presence of a mechanical valve prosthesis in any position.
9. Subjects with a myocardial infarction within 30 days prior to enrollment.
10. Subjects had a prior stroke (of any cause, whether ischemic or hemorrhagic) or transient ischemic attack (TIA) within the 90 days prior to enrollment.
11. Any planned electrical cardioversion within 30 days following LAAC device implant.
12. Subjects with a known inability to obtain vascular access.
13. Subjects with any contraindication to percutaneous catheterization procedure (e.g., patient size does not accommodate required catheters, ventriculotomy or atriotomy), active conditions (e.g. infection, bleeding disorder, unstable angina) or congenital abnormalities (severe rotational anomalies of the heart or great vessels) are present\*.
14. Subjects with any active conditions (e.g. infection, bleeding disorder, unstable angina) are present.
15. Subjects with any contraindications to short term use of anticoagulation therapy, or aspirin for conditions different from atrial fibrillation.
16. Subjects who are pregnant or planning to be pregnant.
17. Subjects with a life expectancy of ≤ 1 year per investigator's opinion.
18. 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 reviewed by the sponsor to determine eligibility.

Where this trial is running

Suzhou, Jiangsu and 33 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Concomitant ProceduresAtrial FibrillationPFALAAC
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.