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BOdygUardian MOnitoriNg for ReCurrencE of AF

BOdygUardian MOnitoriNg for ReCurrencE of AF (BOUNCE-AF)

Who can join

Ages 18 and older · All sexes

Patients must meet all the following criteria to be eligible for inclusion in the BOUNCE-AF sub-study:

1. Eligible for and willing to consent for participation in DISRUPT-AF
2. Willing to consent to the sub-study
3. Willing to complete the post-ablation BodyGuardian wearable monitoring
4. Willing to complete the BOUNCE AF survey

Clinical staff willing to consent to complete surveys must meet one of the following requirements:

1. Prescribe the monitor by enrolling patients into the BodyGuardian platform.
2. Review monitor data using the BodyGuardian platform.

Exclusion Criteria:

1\. Known allergy to adhesives that would contraindicate wearing BodyGuardian

About the study

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.

What is being tested

• BodyGuardian (device)

Sponsor: Heart Rhythm Clinical and Research Solutions, LLC · Participants: 100 · Started: Aug 13, 2026

Contact the study team

• Kayla Oliver · Phone: 763-381-7972
• Megan Goodfellow · Phone: 563-599-4146

Official record on ClinicalTrials.gov — NCT07671677

Locations in the U.S.

Conditions

• Atrial Fibrillation

From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.