About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Eligible for and willing to consent for participation in DISRUPT-AF
Willing to consent to the sub-study
Willing to complete the post-ablation BodyGuardian wearable monitoring
Willing to complete the BOUNCE AF survey
Disqualifiers
None
Trial population
Up to 100 patients from the full-monitoring arm of the DISRUPT-AF Registry
Trial design
Cohort
Prospective
Treatments tested in this trial
BodyGuardian
DeviceBodyGuardian wear at 6 months
Treatment groups
Trial outcomes
Primary outcomes
Primary Objectives
Results will include arrhythmia recurrence and burden, and subjective data on the patient and clinician experience with BodyGuardian. The study will also evaluate reimbursement patterns for post-ablation monitoring, as well as subject compliance to the physician prescribed monitoring duration.
Sponsors and contacts
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Heart Rhythm Clinical and Research Solutions, LLC
Lead sponsor
Boston Scientific Corporation
Collaborator