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cOncomitant Left Atrial aPpendage Closure and Pulsed Field ablaTION-Asia

NCT06686485 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 433

Last updated 2026-05-14

No results posted yet for this 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.

Conditions

Interventions

DEVICE

FARAPULSE™ PFA system and WATCHMAN LAAC Delivery Systems

The FARAPULSE™ PFA System consists of the FARAWAVE™ Pulsed Field Ablation Catheter, the FARASTAR™ Pulsed Field Ablation Generator, and the FARADRIVE™ Steerable Sheath. The WATCHMAN LAA Closure Technology consists of the WATCHMAN Access System (which consists of the Access Sheath and Dilator and the WATCHMAN Delivery System (which consists of the delivery catheter and the pre-loaded closure device). The WATCHMAN Access System and WATCHMAN Delivery System permit device placement in the LAA via femoral venous access and crossing the inter-atrial septum into the left atrium.

Sponsors & Collaborators

  • Boston Scientific Corporation

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-18
Primary Completion
2026-10-31
Completion
2029-10-31

Countries

  • China
  • Hong Kong
  • Japan
  • Malaysia
  • Singapore
  • Taiwan

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06686485 on ClinicalTrials.gov