๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2026-08-25

BOdygUardian MOnitoriNg for ReCurrencE of AF (NCT07671677)

BOdygUardian MOnitoriNg for ReCurrencE of AF (BOUNCE-AF)

๐ŸŸข Recruiting Interventional Protocol ๐Ÿ“Š Observational Clinical Research Sponsor: Heart Rhythm Clinical and Research Solutions, LLC

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

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.

Who can join: Review the eligibility criteria below.

Location: Arrhythmia Center of South Florida โ€” Delray Beach, Florida

Age range: 18 Years

๐Ÿงช Interventions in This Study

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (5 Sites)

  • Arrhythmia Center of South Florida โ€” Delray Beach, Florida
  • HCA Research Institute (FL Mercy Miami) โ€” Miami, Florida
  • University of Iowa Hospitals and Clinics โ€” Iowa City, Iowa
  • Allegheny General Hospital โ€” Pittsburgh, Pennsylvania
  • St. Mark's Hospital โ€” Salt Lake City, Utah

๐Ÿ“ž Contact the Study Coordinator

Phone: (763) 381-7972

Email: koliver@hrcrs.com

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—