RecruitingNot Applicable

cOncomitant Left Atrial aPpendage Closure and Pulsed Field ablaTION-Asia

China433 participantsStarted 2025-03-18

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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.
✓. Subjects who are willing and able to provide informed consent.
✓. Subjects who are willing and able to participate in all testing associated with this clinical study at an approved clinical investigational center.
✓. 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

✕. Subjects who underwent prior AF ablation procedure.
✕. Subjects with atrial fibrillation that is secondary to electrolyte imbalance, thyroid disease, alcohol, or other reversible / non-cardiac causes.
✕. Already surgically closed or otherwise excluded LAA.
✕. The LAA anatomy does not accommodate a Closure Device.
✕. Known or suspected atrial myxoma.
✕. Presence of intracardiac thrombus.
✕. Subjects with a current interatrial baffle or patch, history of atrial septal repair or has an ASD/PFO device.
✕. Subjects with a presence of a mechanical valve prosthesis in any position.

What they're measuring

Periprocedural or procedure-related Composite Serious Adverse Events will be assessed

Timeframe: 30 days post index procedure

Acute Treatment Success will be assessed

Timeframe: between index procedure and 30 days post index procedure

Trial details

NCT IDNCT06686485

SponsorBoston Scientific Corporation

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2026-10-31

Contact for this trial

Jamie Kwek

+6564188833 Jamie.Kwek@bsci.com

View on ClinicalTrials.gov More Concomitant Procedures trials