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NCT07041125 · ClinicalTrials.gov registry record
Concomitant LAAC/AF Ablation (Watchman FLX Pro)
A clinical trial of PFA Ablation and LAAC Procedures, sponsored by Heart Rhythm Clinical and Research Solutions.
- Recruiting
- Registry status
- 120
- Enrollment target
- 11
- Study locations
NCT07041125: Recruiting study of PFA Ablation and LAAC Procedures, sponsored by Heart Rhythm Clinical and Research Solutions.
NCT07041125 is a study of PFA Ablation and LAAC Procedures that is actively recruiting participants, run by Heart Rhythm Clinical and Research Solutions. The registered enrollment target is 120 participants. The trial reports 11 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07041125, a study of PFA Ablation and LAAC Procedures, is actively recruiting participants, sponsored by Heart Rhythm Clinical and Research Solutions.
- RECRUITING
- Registry status
- 120 participants
- Enrollment target
- 11
- Study locations
Study 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).
Primary Outcome
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.
Conditions Studied
Interventions
- DEVICE Watchman FLX™ Pro device.
Study Locations (11)
Florida
- Arrhythmia Center of South Florida - Delray Beach
- Ascension St. Vincent's Jacksonville - Jacksonville
- HCA Research Institute- Mercy Hospital - Miami
Alabama
- Arrhythmia Institute at Grandview - Birmingham
Indiana
- Ascension St Vincent -Indianapolis Ascension Health - Indianapolis
Iowa
- University of Iowa Hospitals and Clinics - Iowa City
Kentucky
- Norton Heart & Vascular Institute - Louisville
Pennsylvania
- Allegheny General Hospital - Pittsburgh
Texas
- Texas Cardiac Arrhythmia Research Foundation - Austin
Utah
- St, Mark's Hospital - Salt Lake City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2025-06-01 |
| Est. Completion | 2026-10-30 |
What NCT07041125 shows while recruiting
NCT07041125 is an observational study that tracks outcomes without assigning an intervention. The registered 120 participants enrollment target is mid-sized for trials with a published cap.
The record links to 1 condition, with PFA Ablation and LAAC Procedures appearing as the primary indexed condition, and to 1 intervention - of which Watchman FLX™ Pro device. is the first listed.
NCT07041125 lists 11 locations in 9 states (Florida, Alabama, Indiana).
Frequently Asked Questions
What is clinical trial NCT07041125 about?
NCT07041125 is a clinical study titled "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).
What is the current status of trial NCT07041125?
This trial is currently recruiting. The enrollment target is 120 participants. The study started on 2025-06-01. Estimated completion is 2026-10-30.
What conditions does trial NCT07041125 study?
This clinical trial studies the following conditions: PFA Ablation and LAAC Procedures.
What interventions are being tested in trial NCT07041125?
The interventions under investigation include: Watchman FLX™ Pro device. (DEVICE).
Who is sponsoring clinical trial NCT07041125?
This trial is sponsored by Heart Rhythm Clinical and Research Solutions, which has 9 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07041125 being conducted?
This trial has 11 study locations across Alabama, Florida, Indiana, Iowa, Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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