BOdygUardian MOnitoriNg for ReCurrencE of AF

Trial statusRecruiting
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

This trial does not accept healthy volunteers

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 population

Up to 100 patients from the full-monitoring arm of the DISRUPT-AF Registry

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • BodyGuardian

    Device

    BodyGuardian wear at 6 months

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

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.

Time frame
From enrollment to the end of BodyGuardian wear at 6 months

Secondary outcomes

Other outcomes

Sponsors and contacts

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Heart Rhythm Clinical and Research Solutions, LLC

Lead sponsor

Boston Scientific Corporation

Collaborator