An observational study in PFA Ablation and LAAC Procedures, sponsored by Heart Rhythm Clinical and Research Solutions, LLC. Completed at 15 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-31.
Sponsored by Heart Rhythm Clinical and Research Solutions, LLC · Observational
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).
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 After AF ablation, the FARAWAVE Catheter will be withdrawn.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
Heart Rhythm Clinical and Research Solutions, LLC is the lead sponsor of 11 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients eligible for the main DISRUPT-AF Registry with a planned concomitant LAAC procedure using the Watchman FLX™ Pro device
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:
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
AF ablation and LAAC procedures are performed per operators' standard practice. AF ablation will include PVI. Additional right or left atrial ablations are per investigators' discretions. Both AF ablation and LAAC procedures may be performed with ICE or TEE. Assessment of LAAC peri-device leaks and device-related thrombi at 45-90 days may be performed with TEE or cardiac computed tomography angiography (CCTA).
Device: Watchman FLX™ Pro device.
Patients eligible for the main DISRUPT-AF Registry with a planned concomitant LAAC procedure using the Watchman FLX™ Pro device.
The occurrence of events between the time of implant and within 7 days following the procedure
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.
Time frame: 12 months
LAAC success and late-onset safety
45-90 days leaks around LAAC device, 45-90 days device-related thrombus and
Time frame: 12 months
Procedural efficiency:
Number of transseptal crossings, Total procedure time of concomitant, Relative difference in procedure time of stand-alone PFA procedure timevs. concomitant PFA
Time frame: 12 months
This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Heart Rhythm Clinical and Research Solutions, LLC