Concomitant LAAC/AF Ablation (Watchman FLX Pro)
Ablation With FARAPULSE and Left Atrial Appendage Closure With Watchman for Integrated Management of Atrial Fibrillation)
1 other identifier
observational
120
1 country
11
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jun 2025
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2025
CompletedFirst Submitted
Initial submission to the registry
June 19, 2025
CompletedFirst Posted
Study publicly available on registry
June 27, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 30, 2026
September 24, 2025
September 1, 2025
1.3 years
June 19, 2025
September 18, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
12 months
Secondary Outcomes (1)
LAAC success and late-onset safety
12 months
Other Outcomes (1)
Procedural efficiency:
12 months
Study Arms (1)
Combining LAAC and PFA ablation procedures
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).
Interventions
Patients eligible for the main DISRUPT-AF Registry with a planned concomitant LAAC procedure using the Watchman FLX™ Pro device.
Eligibility Criteria
Patients eligible for the main DISRUPT-AF Registry with a planned concomitant LAAC procedure using the Watchman FLX™ Pro device
You may qualify if:
- 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)
You may not qualify if:
- Patients who are participating in other DISRUPT-AF sub-studies
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (11)
Arrhythmia Institute at Grandview
Birmingham, Alabama, 35243, United States
Arrhythmia Center of South Florida
Delray Beach, Florida, 33484, United States
Ascension St. Vincent's Jacksonville
Jacksonville, Florida, 32204, United States
HCA Research Institute- Mercy Hospital
Miami, Florida, 37203, United States
Ascension St Vincent -Indianapolis Ascension Health
Indianapolis, Indiana, 46184, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242, United States
Norton Heart & Vascular Institute
Louisville, Kentucky, 40205, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212, United States
Texas Cardiac Arrhythmia Research Foundation
Austin, Texas, 78705, United States
St, Mark's Hospital
Salt Lake City, Utah, 84124, United States
Chippenham Hospital)
Richmond, Virginia, 23225, United States
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Target Duration
- 90 Days
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 19, 2025
First Posted
June 27, 2025
Study Start
June 1, 2025
Primary Completion (Estimated)
September 30, 2026
Study Completion (Estimated)
October 30, 2026
Last Updated
September 24, 2025
Record last verified: 2025-09