BOdygUardian MOnitoriNg for ReCurrencE of AF

Starting soon

Conditions studied: Atrial Fibrillation (AF)

In brief

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.

Key facts

Study ID

NCT07671677

Run by

Heart Rhythm Clinical and Research Solutions, LLC

People needed

100

Starts

2026-07-01

Expected to finish

2028-04-01

Last updated by the study team

2026-06-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Known allergy to adhesives that would contraindicate wearing BodyGuardian

Where it is running

• Arrhythmia Center of South Florida — Delray Beach, Florida, United States
• Allegheny General Hospital — Pittsburgh, Pennsylvania, United States
• St. Mark's Hospital — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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