Ablation With FARAPULSE and Left Atrial Appendage Closure With Watchman for Integrated Management of Atrial Fibrillation)
Heart Rhythm Clinical and Research Solutions, LLC
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).
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 sta…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- Not specified
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 include…
Interventions
- DeviceWatchman FLX™ Pro device.
Patients eligible for the main DISRUPT-AF Registry with a planned concomitant LAAC procedure using the Watchman FLX™ Pro device.
Locations (11)
- Arrhythmia Institute at GrandviewBirmingham, Alabama
- Arrhythmia Center of South FloridaDelray Beach, Florida
- Ascension St. Vincent's JacksonvilleJacksonville, Florida
- HCA Research Institute- Mercy HospitalMiami, Florida
- Ascension St Vincent -Indianapolis Ascension HealthIndianapolis, Indiana
- University of Iowa Hospitals and ClinicsIowa City, Iowa