Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT07041125

Concomitant LAAC/AF Ablation (Watchman FLX Pro)

This sub-study is a prospective/retrospective, non-randomized, observational, comparative cohorts study, embedded in and expanding on the infrastructure of a real-world AF ablation registry DISRUPT-AF (NCT06335082).

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Arrhythmia Institute at Grandview, Birmingham, Alabama, United States

Loading trial locations.

About this study

The prospective arm of the sub-study is intended to enroll 120 subjects indicated for PFA and Watchman in up to 20 US sites within the framework of the DISRUPT-AF registry. Subjects will be screened for eligibility to participate in concomitant PFA ablation for AF and LAAC by Watchman FLX Pro device in a single procedure. Both PVI and LAAC procedures are performed per SOC. In general, percutaneous catheterization will be initially established using FARADRIVE™ steerable sheath for ablation treatment of AF using the FARAWAVE Catheter per instruction for use (IFU) of the device and operator's standard practice. AF ablation will include PVI. Additional right or left atrial ablations are per investigators' discretions. After AF ablation, the FARAWAVE Catheter will be withdrawn. The FARADRIVE™ steerable sheath will be replaced with Watchman FLX deployment sheath. Deployment of Watchman FLX Pro device to LAA to achieve LAAC will follow the standard practice of the care and IFU of the device. Patients will be followed up at 45-90 days for LAAC implant assessment and at 3, 6, and 12 months for arrhythmia recurrence assessment

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

All inclusion criteria of the main DISRUPT-AF registry will apply. In addition, patients included in this sub study must meet the additional inclusion criteria below:

  • Patients who are determined by physicians to be eligible for LAAC
  • Patients whose LAAC with Watchman FLX Pro procedures are performed concomitant following AF ablation procedure
  • Willing and able to provide additional informed consent to the sub-study (unless waiver of consent is obtained)

Exclusion criteria

All exclusion criteria of the main DISRUPT-AF registry will apply. In addition, patients included in this sub study have the additional exclusion criteria below:

-Patients who are participating in other DISRUPT-AF sub-studies

Treatment and study plan

Watchman FLX™ Pro device.

Device

Patients eligible for the main DISRUPT-AF Registry with a planned concomitant LAAC procedure using the Watchman FLX™ Pro device.

Primary outcomes

  1. The occurrence of events between the time of implant and within 7 days following the procedure

    Time frame: 12 months

    AF ablation safety will be compared between the concomitant procedures and standalone AF ablation cohort. and LAAC procedure safety will be compared between the concomitant procedures and standalone LAAC cohort.

Secondary outcomes

  1. LAAC success and late-onset safety

    Time frame: 12 months

    45-90 days leaks around LAAC device, 45-90 days device-related thrombus and

Other outcomes

  1. Procedural efficiency:

    Time frame: 12 months

    Number of transseptal crossings, Total procedure time of concomitant, Relative difference in procedure time of stand-alone PFA procedure timevs. concomitant PFA

Sponsors and collaborators

Lead sponsor

Heart Rhythm Clinical and Research Solutions, LLC

Other

Collaborators

  • Boston Scientific Corporation

Registry information

Official study title

Ablation With FARAPULSE and Left Atrial Appendage Closure With Watchman for Integrated Management of Atrial Fibrillation)

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 27, 2025
Registry last updated
Jul 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.