Wearable heart monitor to detect returning atrial fibrillation after ablation
Studies a wearable monitor for atrial fibrillation returning after ablation treatment.
Plain-language title generated from the registry record
Registry title: BOdygUardian MOnitoriNg for ReCurrencE of AF
Key facts
- Where
- Delray Beach, Iowa City, Miami, Pittsburgh, and Salt Lake City, United StatesSee the 5 sites
Where in United States
- Arrhythmia Center of South FloridaDelray Beach, United StatesTaking people
- University of Iowa Hospitals and ClinicsIowa City, United StatesNot yet recruiting
- HCA Research Institute (FL Mercy Miami)Miami, United StatesTaking people
- Allegheny General HospitalPittsburgh, United StatesTaking people
- St. Mark's HospitalSalt Lake City, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Heart Rhythm Clinical and Research Solutions, LLC
- Trial code
- NCT07671677
- Record updated
- 28 October 2026
- Original description
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.Read full original descriptionShow less
BOdygUardian MOnitoriNg for ReCurrencE of AF (BOUNCE-AF)
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.
Exclusion: Known allergy to adhesives that would contraindicate wearing BodyGuardian.
Patients must meet all the following criteria to be eligible for inclusion in the BOUNCE-AF sub-study:; 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; Clinical staff willing to consent to complete surveys must meet one of the following requirements:; Prescribe the monitor by enrolling patients into the BodyGuardian platform; Review monitor data using the BodyGuardian platform.