Concomitant LAAC/AF Ablation (Watchman FLX Pro)

Recruiting

• Conditions: PFA Ablation and LAAC Procedures

• Registration Number: NCT07041125
• Lead Sponsor: Heart Rhythm Clinical and Research Solutions, LLC

Brief Summary

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).

Detailed Description

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 After AF ablation, the FARAWAVE Catheter will be withdrawn.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

Study Timeline

• Study Start: 2025-06-01
• Study First Submitted: 2025-06-19
• Study First Submitted QC: 2025-06-19
• Study First Posted: 2025-06-27
• Status Verified: 2025-09
• Last Update Submitted: 2025-09-18
• Last Update Posted: 2025-09-24
• Primary Completion: 2026-09-30
• Study Completion: 2026-10-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The occurrence of events between the time of implant and within 7 days following the procedure	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 Outcome Measures

Name	Time	Method
LAAC success and late-onset safety	12 months	45-90 days leaks around LAAC device, 45-90 days device-related thrombus and

Trial Locations

Locations (11)

Arrhythmia Institute at Grandview; 🇺🇸 Birmingham, Alabama, United States

Norton Heart & Vascular Institute; 🇺🇸 Louisville, Kentucky, United States

St, Mark's Hospital; 🇺🇸 Salt Lake City, Utah, United States

Chippenham Hospital); 🇺🇸 Richmond, Virginia, United States

Arrhythmia Center of South Florida; 🇺🇸 Delray Beach, Florida, United States

Ascension St. Vincent's Jacksonville; 🇺🇸 Jacksonville, Florida, United States

HCA Research Institute- Mercy Hospital; 🇺🇸 Miami, Florida, United States

Ascension St Vincent -Indianapolis Ascension Health; 🇺🇸 Indianapolis, Indiana, United States

University of Iowa Hospitals and Clinics; 🇺🇸 Iowa City, Iowa, United States

Allegheny General Hospital; 🇺🇸 Pittsburgh, Pennsylvania, United States

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