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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BOdygUardian MOnitoriNg for ReCurrencE of AF (BOUNCE-AF)
- ClinicalTrials.gov ID
- NCT07671677
- Acronym / sponsor ID
- BOUNCE-AF / CTP-28
- Conditions
- Atrial Fibrillation (AF)
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Heart Rhythm Clinical and Research Solutions, LLCUniversity, hospital or other
- Collaborators
- Boston Scientific Corporation
- Study start
- 13 Aug 2026 (actual)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Apr 2028 (estimated)
- First posted
- 26 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Up to 100 patients from the full-monitoring arm of the DISRUPT-AF Registry
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- 1. Known allergy to adhesives that would contraindicate wearing BodyGuardian
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BodyGuardianBodyGuardian wear at 6 months | Device | – |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
Related trials for Atrial Fibrillation (AF)
Not yet recruiting
Exclusion of Left Atrial Appendage Thrombus in Emergency Department Patients With Atrial Fibrillation Undergoing CT to Assess for Pulmonary Embolus: A Feasibility Study
Atrial Fibrillation (AF), Pulmonary Embolism (PE)
RecruitingObservational study
Mechanisms of Myocardial Injury and Ischemia in Patients With Rapid Atrial Fibrillation
Atrial Fibrillation (AF)
RecruitingPhase 3
Stroke and Systemic Embolism Prevention in Adult Participants With Atrial Fibrillation
Atrial Fibrillation (AF)
RecruitingObservational study
Association Between Circulating BDNF Levels and Atrial Cardiomyopathy in Patients Undergoing Ablation for Persistent Atrial Fibrillation
Atrial Fibrillation (AF), Cardiac Arrhythmia
Recruiting
PVI Alone vs PVI and Linear Ablation for Persistent Atrial Fibrillation (PROMPT AF II)
Persistent Atrial Fibrillation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation (AF), run by Heart Rhythm Clinical and Research Solutions, LLC at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kayla Oliver (763-381-7972, koliver@hrcrs.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Objectives (time frame: From enrollment to the end of BodyGuardian wear at 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.