Fact CheckerSign in

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
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

Full criteria on ClinicalTrials.gov

Sites (5)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Arrhythmia Center of South Florida
Coordinator of this site? Confirm its status
Delray BeachUnited StatesRecruiting
University of Iowa Hospitals and Clinics
Coordinator of this site? Confirm its status
Iowa CityUnited StatesNot yet recruiting
HCA Research Institute (FL Mercy Miami)
Coordinator of this site? Confirm its status
MiamiUnited StatesRecruiting
Allegheny General Hospital
Coordinator of this site? Confirm its status
PittsburghUnited StatesRecruiting
St. Mark's Hospital
Coordinator of this site? Confirm its status
Salt Lake CityUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.