Atrial Fibrillation (AF)BOUNCE-AFNCT07671677
BOdygUardian MOnitoriNg for ReCurrencE of AF
An observational study of Atrial Fibrillation (AF), run by Heart Rhythm Clinical and Research Solutions, LLC at 5 sites in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation (AF)
- What is being tested?
- BodyGuardian
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 5 sitesUnited States
- Study dates
- 13 Aug 2026to Apr 2028
- How long will I take part?
- 6 Months
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Up to 100 patients from the full-monitoring arm of the DISRUPT-AF Registry
Who may be able to join
None listed.
Who cannot join
- 1. Known allergy to adhesives that would contraindicate wearing BodyGuardian
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
United States5 sites, 5 recruiting
- Recruiting
Arrhythmia Center of South Florida
Delray Beach, Florida, 33484
Julianna Restrepo, julianna@vivasmd.com
Alexandra "Ali" Beaumont, (561) 303 -3491, ali@vivasmd.com
- Not yet recruiting
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
Trisha Elliott, 319-384-1628, trisha-elliott@uiowa.edu
Paari Dominic
- Recruiting
HCA Research Institute (FL Mercy Miami)
Miami, Florida, 37133
Ana Portela, 305-285-2976, ana.portela@hcahealthcare.com
Jose Osorio
- Not yet recruiting
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212
Caitlin Phalunas, 412-359-3457, Caitlin.phalunas@ahn.org
- Not yet recruiting
St. Mark's Hospital
Salt Lake City, Utah, 84124
Sherry Fisher
About this study
Official title: 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.
- Conditions
- Atrial Fibrillation (AF)
- Being tested
- BodyGuardian
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BodyGuardianDevice
BodyGuardian wear at 6 months
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Objectives
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.
Measured: From enrollment to the end of BodyGuardian wear at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2026
- Study start13 Aug 2026
- Primary completionJan 2028 (estimated)
- Study completionApr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial Fibrillation (AF)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Heart Rhythm Clinical and Research Solutions, LLC
- Sponsor type
- University, hospital or other
- Collaborators
- Boston Scientific Corporation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07671677
- Sponsor's protocol ID
- CTP-28
- Acronym
- BOUNCE-AF
- Status last verified
- Jun 2026
- First submitted
- 17 Jun 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No