BOdygUardian MOnitoriNg for ReCurrencE of AF

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorHeart Rhythm Clinical and Research Solutions, LLC

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

Qualifiers

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 design

Treatments tested in this trial

  • BodyGuardian

Treatment groups

No treatment groups listed

Sponsors and collaborators

Heart Rhythm Clinical and Research Solutions, LLC

Lead sponsor

Boston Scientific Corporation

Collaborator