Clinical Trial

BOdygUardian MOnitoriNg for ReCurrencE of AF

Study acronym: BOUNCE-AF
Not Yet Recruiting
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Summary
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.
Trial Details
NCT Number NCT07671677
Lead Sponsor Heart Rhythm Clinical and Research Solutions, LLC
Collaborators: Boston Scientific Corporation
Conditions Atrial Fibrillation (AF)
Enrollment 100 participants
Start Date 2026-07
Primary Completion 2028-01 (estimated)
Study Completion 2028-04 (estimated)
Updated on ClinicalTrials.gov 2026-06-26