Atrial Fibrillation Clinical Trials

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BOdygUardian MOnitoriNg for ReCurrencE of AF (BOUNCE-AF)

Status: Recruiting
Location: See all (5) locations...
Intervention Type: Device
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
Florida
Arrhythmia Center of South Florida
RECRUITING
Delray Beach
HCA Research Institute (FL Mercy Miami)
NOT_YET_RECRUITING
Miami
Iowa
University of Iowa Hospitals and Clinics
NOT_YET_RECRUITING
Iowa City
Pennsylvania
Allegheny General Hospital
NOT_YET_RECRUITING
Pittsburgh
Utah
St. Mark's Hospital
NOT_YET_RECRUITING
Salt Lake City
Contact Information
Primary
Kayla Oliver
koliver@hrcrs.com
763-381-7972
Backup
Megan Goodfellow
mgoodfellow@hrcrs.com
563-599-4146
Time Frame
Start Date: 2026-08-13
Estimated Completion Date: 2028-04
Participants
Target number of participants: 100
Related Therapeutic Areas
Sponsors
Collaborators: Boston Scientific Corporation
Leads: Heart Rhythm Clinical and Research Solutions, LLC

This content was sourced from clinicaltrials.gov