cOncomitant Left Atrial aPpendage Closure and Pulsed Field ablaTION-Asia

Last updated: April 23, 2025
Sponsor: Boston Scientific Corporation
Overall Status: Active - Recruiting

Phase

N/A

Condition

Arrhythmia

Cardiac Disease

Atrial Fibrillation

Treatment

FARAPULSE™ PFA system and WATCHMAN LAAC Delivery Systems

Clinical Study ID

NCT06686485
PF316
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Clinically indicated for treatment with both the FARAPULSE™ PFA system and withWATCHMAN for LAAC, per physician medical judgement and as per hospitals' standard ofcare.

  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 thisclinical study at an approved clinical investigational center.

  4. Subjects whose age is 18 years or above, or who are of legal age to give informedconsent specific to state and national law.

Exclusion

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 repairor 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) ortransient 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 congenitalabnormalities (severe rotational anomalies of the heart or great vessels) arepresent*.

  14. Subjects with any contraindications to short term use of anticoagulation therapy, oraspirin 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 registrythat would directly interfere with the current study, except when the subject isparticipating in a mandatory governmental registry, or a purely observationalregistry with no associated treatments. Each instance must be reviewed by thesponsor to determine eligibility.

Study Design

Total Participants: 433
Treatment Group(s): 1
Primary Treatment: FARAPULSE™ PFA system and WATCHMAN LAAC Delivery Systems
Phase:
Study Start date:
March 18, 2025
Estimated Completion Date:
October 31, 2029

Study 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.

Connect with a study center

  • Institute Jantung Negara

    Kuala Lumpur,
    Malaysia

    Active - Recruiting

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