NCT07671677 · Heart Rhythm Clinical and Research Solutions, LLC
BOdygUardian MOnitoriNg for ReCurrencE of AF
(BOUNCE-AF)
What this study is about
The DISRUPT-AF Registry is an observational, forward-looking, multi-center, non-randomly assigned, 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.
View original scientific description
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.
Interventions
DEVICE
BodyGuardian
BodyGuardian wear at 6 months
Primary outcome measures
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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.
Exclusion criteria
- 1\. Known allergy to adhesives that would contraindicate wearing BodyGuardian
Where
- Delray Beach, Florida
- Miami, Florida
- Iowa City, Iowa
- Pittsburgh, Pennsylvania
- Salt Lake City, Utah
Collaborators
Boston Scientific Corporation
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 27, 2026 · Source of record for eligibility and locations