NCT07671677Recruiting
BOdygUardian MOnitoriNg for ReCurrencE of AF
BOdygUardian MOnitoriNg for ReCurrencE of AF (BOUNCE-AF)
Source: ClinicalTrials.gov · Last updated 28 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 100 (estimated)
- First submitted
- 17 Jun 2026
- Start date
- 13 Aug 2026
- Primary completion date
- Jan 2028
- Lead sponsor
- Heart Rhythm Clinical and Research Solutions, LLC
- Diseases
- Atrial fibrillation
- NCT number
- NCT07671677
What you commit to
- Study type: Observational
- Planned participants: 100
- From 13 Aug 2026 to the primary completion date, Jan 2028
- 5 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 1\. Known allergy to adhesives that would contraindicate wearing BodyGuardian
Criteria the registry did not label
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Arrhythmia Center of South Florida Coordinator of this site? Confirm its status | Delray Beach | United States | Recruiting |
| University of Iowa Hospitals and Clinics Coordinator of this site? Confirm its status | Iowa City | United States | Not yet recruiting |
| HCA Research Institute (FL Mercy Miami) Coordinator of this site? Confirm its status | Miami | United States | Recruiting |
| Allegheny General Hospital Coordinator of this site? Confirm its status | Pittsburgh | United States | Recruiting |
| St. Mark's Hospital Coordinator of this site? Confirm its status | Salt Lake City | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.