BOdygUardian MOnitoriNg for ReCurrencE of AF
BOUNCE-AF
1 other identifier
observational
100
1 country
3
Brief 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). 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jul 2026
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 17, 2026
CompletedFirst Posted
Study publicly available on registry
June 26, 2026
CompletedStudy Start
First participant enrolled
July 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 1, 2028
June 26, 2026
June 1, 2026
1.5 years
June 17, 2026
June 23, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
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.
From enrollment to the end of BodyGuardian wear at 6 months
Interventions
BodyGuardian wear at 6 months
Eligibility Criteria
Up to 100 patients from the full-monitoring arm of the DISRUPT-AF Registry
You may not qualify if:
- \. Known allergy to adhesives that would contraindicate wearing BodyGuardian
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Arrhythmia Center of South Florida
Delray Beach, Florida, 33484, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212, United States
St. Mark's Hospital
Salt Lake City, Utah, 84124, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 6 Months
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 17, 2026
First Posted
June 26, 2026
Study Start
July 1, 2026
Primary Completion (Estimated)
January 1, 2028
Study Completion (Estimated)
April 1, 2028
Last Updated
June 26, 2026
Record last verified: 2026-06