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NCT Number: NCT07671677

BOdygUardian MOnitoriNg for ReCurrencE of AF

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Arrhythmia Center of South Florida, Delray Beach, Florida, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Patients must meet all the following criteria to be eligible for inclusion 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

  • Known allergy to adhesives that would contraindicate wearing BodyGuardian

Treatment and study plan

BodyGuardian

Device

BodyGuardian wear at 6 months

Primary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Kayla Oliver

CONTACT

[email protected]

763-381-7972

Megan Goodfellow

CONTACT

[email protected]

563-599-4146

Sponsors and collaborators

Lead sponsor

Heart Rhythm Clinical and Research Solutions, LLC

Other

Collaborators

  • Boston Scientific Corporation

Registry information

Official study title

BOdygUardian MOnitoriNg for ReCurrencE of AF (BOUNCE-AF)

Acronym: BOUNCE-AF

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jun 26, 2026
Registry last updated
Jun 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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