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Same‑session pulsed‑field AF ablation with Watchman FLX Pro left atrial appendage closure

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

Observational Heart Rhythm Clinical and Research Solutions, LLC · NCT07041125

This project tests whether doing pulsed‑field AF ablation and placing a Watchman FLX Pro device in the same procedure is safe and effective for people with atrial fibrillation who are candidates for both treatments.

Quick facts

Study typeObservational
Enrollment120 (estimated)
Ages18 Years and up
SexAll
SponsorHeart Rhythm Clinical and Research Solutions, LLC Academic / other
Locations11 sites (Birmingham, Alabama and 10 other locations)
Trial IDNCT07041125 on ClinicalTrials.gov

What this trial studies

This sub-study uses prospective and retrospective non-randomized cohorts embedded within the DISRUPT-AF registry and plans to enroll about 120 subjects across up to 20 US sites. Eligible patients undergo pulsed‑field catheter ablation (including pulmonary vein isolation) using the FARADRIVE steerable sheath and FARAWAVE catheter, followed in the same session by replacement of the sheath and deployment of a Watchman FLX Pro device for left atrial appendage closure. Procedures follow standard of care and device instructions for use, with additional ablations at the investigator's discretion. Follow-up visits occur at 45–90 days for implant assessment and at 3, 6, and 12 months for arrhythmia recurrence and clinical outcomes.

Who should consider this trial

Good fit: Ideal candidates are adults with atrial fibrillation who are judged eligible for left atrial appendage closure and for whom physicians plan pulsed‑field AF ablation and Watchman FLX Pro placement in the same session.

Not a fit: Patients who are not eligible for LAAC, who require staged procedures, or who cannot undergo catheter ablation at an enrolling center are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, the approach could allow patients to receive AF ablation and left atrial appendage closure in a single procedure, reducing overall procedural burden and recovery time.

How similar studies have performed: Combining AF ablation and LAAC has been performed with radiofrequency and cryoballoon techniques with promising observational results, but concomitant use of pulsed‑field ablation with Watchman FLX Pro is relatively novel and not yet widely studied.

Eligibility criteria

Show full inclusion / exclusion criteria 
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

Where this trial is running

Birmingham, Alabama and 10 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions PFA Ablation and LAAC ProceduresAF ablationFARADRIVE™Watchman FLX Pro
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.