cOncomitant Left Atrial aPpendage Closure and Pulsed Field ablaTION-Asia

Recruiting

• Conditions: Concomitant Procedures; Atrial Fibrillation; PFA; LAAC

• Registration Number: NCT06686485
• Lead Sponsor: Boston Scientific Corporation

Brief Summary

Subjects enrolled in the OPTION-A study will be clinically indicated for atrial fibrillation (AF) ablation procedure with the FARAPULSE™ PFA system and treatment with WATCHMAN LAAC Device, per physician's medical judgement and according to hospitals' standard of care during the same procedure.

Detailed Description

The OPTION-A Study is an observational, prospective, single-arm, multi-center non-mandated post-market study. Subjects enrolled in the OPTION-A study will be clinically indicated for atrial fibrillation (AF) ablation procedure with the FARAPULSE PFA system and treatment with WATCHMAN LAAC Device, per physician's medical judgement and according to hospitals' standard of care. The objective(s) of the OPTION-A Study is to evaluate safety and effectiveness of catheter ablation with the FARAPULSE™ Pulsed Field Ablation (PFA) System and subsequent implant of Left Atrial Appendage closure (LAAC) with the WATCHMAN™ LAA Closure device in a concomitant procedure.

Study Timeline

• Study First Submitted: 2024-11-08
• Study First Submitted QC: 2024-11-11
• Study First Posted: 2024-11-13
• Study Start: 2025-03-18
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-23
• Last Update Posted: 2025-04-25
• Primary Completion: 2026-10-31
• Study Completion: 2029-10-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 433

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 contraindications to short term use of anticoagulation therapy, or aspirin for conditions different from atrial fibrillation.
15. Subjects who are pregnant or planning to be pregnant.
16. Subjects with a life expectancy of ≤ 1 year per investigator's opinion.
17. 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Periprocedural or procedure-related Composite Serious Adverse Events will be assessed	30 days post index procedure	The primary safety endpoint (PSE) is the proportion of subjects with one or more of the periprocedural device or procedure-related Composite Serious Adverse Events (CSAEs) assessed at 30 days following the Index Procedure.
Acute Treatment Success will be assessed	between index procedure and 30 days post index procedure	The primary effectiveness endpoint (PEE) is the proportion of subjects with Acute Treatment Success assessed among those receiving ≥1 PFA application and who have a WATCHMAN attempted or implanted.

Secondary Outcome Measures

Name	Time	Method
Device or procedure-related Composite Serious Adverse Events (CSAEs) assessed	1 year post index procedure	Device or procedure-related Composite Serious Adverse Events (CSAEs) assessed at 360 days following the Index Procedure

Trial Locations

Locations (1)

Institute Jantung Negara; 🇲🇾 Kuala Lumpur, Malaysia