BodyGuardian Monitoring for Recurrence of Atrial Fibrillation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The DISRUPT-AF Registry is an observational, prospective, multi-center effort to gather real-world experience with the BodyGuardian wearable in patients treated with pulsated field ablation for AF. This sub-study, BOUNCE-AF, enrolls patients from the existing DISRUPT AF Registry and, for eligible participants, surveys them about their experience while wearing the device at 6 months after ablation. Clinical staff involved in prescribing, deploying, or training on the monitor may also complete a separate survey. Follow-up monitoring aligns with each site’s standard of care, typically at 6 and 12 months post-ablation. The trial collects interpretive data on device usability, patient experience, and potential impacts on post-procedural monitoring workflows.

Why it matters

Who can join: the full rules

Patients must meet all the following criteria to be eligible for inclusion in the BOUNCE-AF sub-study:

1. Eligible for and willing to consent for participation in DISRUPT-AF
2. Willing to consent to the sub-study
3. Willing to complete the post-ablation BodyGuardian wearable monitoring
4. Willing to complete the BOUNCE AF survey

Clinical staff willing to consent to complete surveys must meet one of the following requirements:

1. Prescribe the monitor by enrolling patients into the BodyGuardian platform.
2. Review monitor data using the BodyGuardian platform.

Exclusion Criteria:

1\. Known allergy to adhesives that would contraindicate wearing BodyGuardian

Where it's running

• Arrhythmia Center of South Florida
  Delray Beach, Florida, United States Recruiting
• HCA Research Institute (FL Mercy Miami)
  Miami, Florida, United States Recruiting
• Allegheny General Hospital
  Pittsburgh, Pennsylvania, United States Recruiting
• St. Mark's Hospital
  Salt Lake City, Utah, United States Recruiting
• University of Iowa Hospitals and Clinics
  Iowa City, Iowa, United States Not yet recruiting

Study contacts

• Study coordinator: Kayla Oliver
• Email: koliver@hrcrs.com
• Phone: 763-381-7972

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.