BOdygUardian MOnitoriNg for ReCurrencE of AF
Recruiting · NCT07671677 · Observational (researchers observe without assigning treatment) · Lead sponsor: Heart Rhythm Clinical and Research Solutions, LLC
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
The DISRUPT-AF Registry is an observational, prospective, multi-center, non-randomized, real-world registry designed to obtain clinical experience with the FARAPULSE Pulsed Field Ablation (PFA) System for the treatment of atrial fibrillation (AF). The data collected for this study will be from a subset of patients enrolled in the pre-existing DISRUPT AF Registry. Additionally, patients in the Full Monitoring Arm may be approached and consented for participation in BOUNCE-AF. The post-ablation monitoring timepoints will reflect the site's standard of care (SOC), which is typically at 6- and 12-months post-ablation. Consented patients will complete 1 survey about their experience after wearing the BodyGuardian at 6-months. Clinical staff that consent will also complete a survey on their experience using BodyGuardian. The clinical staff include those that either directly prescribe the monitor, place the monitor on the patient and/or train the patient on the use of the monitor, or those involved in reviewing the data.
Who can take part
Eligibility criteria (as published)
Where it is running
5 locations listed across 4 US states.
- Arrhythmia Center of South Florida - Delray Beach, Florida, United States
- HCA Research Institute (FL Mercy Miami) - Miami, Florida, United States
- University of Iowa Hospitals and Clinics - Iowa City, Iowa, United States
- Allegheny General Hospital - Pittsburgh, Pennsylvania, United States
- St. Mark's Hospital - Salt Lake City, Utah, United States