BOdygUardian MOnitoriNg for ReCurrencE of AF (BOUNCE-AF)

August 25, 2026 updated by: Heart Rhythm Clinical and Research Solutions, LLC

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Florida
      • Delray Beach, Florida, United States, 33484
        • Recruiting
        • Arrhythmia Center of South Florida
        • Contact:
        • Contact:
          • Alexandra "Ali" Beaumont
          • Phone Number: (561) 303 -3491
          • Email: ali@vivasmd.com
        • Principal Investigator:
          • Yoel Vivas
        • Sub-Investigator:
          • Luis Mora
        • Sub-Investigator:
          • Mark Freher
      • Miami, Florida, United States, 37133
        • Not yet recruiting
        • HCA Research Institute (FL Mercy Miami)
        • Principal Investigator:
          • Jose Osorio
        • Contact:
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Not yet recruiting
        • University of Iowa Hospitals and Clinics
        • Contact:
        • Principal Investigator:
          • Paari Dominic
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15212
        • Not yet recruiting
        • Allegheny General Hospital
        • Contact:
    • Utah
      • Salt Lake City, Utah, United States, 84124
        • Not yet recruiting
        • St. Mark's Hospital
        • Contact:
          • Sherry Fisher

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Up to 100 patients from the full-monitoring arm of the DISRUPT-AF Registry

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary Objectives
Time Frame: From enrollment to the end of BodyGuardian wear at 6 months
Results will include arrhythmia recurrence and burden, and subjective data on the patient and clinician experience with BodyGuardian. The study will also evaluate reimbursement patterns for post-ablation monitoring, as well as subject compliance to the physician prescribed monitoring duration.
From enrollment to the end of BodyGuardian wear at 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Heart Rhythm Clinical and Research Solutions, LLC

Collaborators

Boston Scientific Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 13, 2026

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

April 1, 2028

Study Registration Dates

First Submitted

June 17, 2026

First Submitted That Met QC Criteria

June 23, 2026

First Posted (Actual)

June 26, 2026

Study Record Updates

Last Update Posted (Actual)

August 27, 2026

Last Update Submitted That Met QC Criteria

August 25, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CTP-28

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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