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New study tests wearable patch to catch hidden heart rhythm problems

NCT ID NCT07671677

Knowledge-focused Sponsor: Heart Rhythm Clinical and Research Solutions, LLC Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 28, 2026 · Updated 2 times

Summary

This study will enroll 100 people who have already had a heart procedure (pulsed field ablation) for atrial fibrillation. Participants will wear a BodyGuardian monitor for a period after the procedure to see if it catches any return of irregular heartbeats. The study also asks patients and their doctors about their experience with the monitor. The goal is to learn how well this wearable works in real-world settings and how often insurance covers it.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could show that the BodyGuardian monitor is a practical tool for tracking AF recurrence after ablation, potentially improving follow-up care.
What could go wrong
This is an observational study, not a treatment trial. It is small (100 participants) and only collects data, so it cannot prove the monitor improves health outcomes.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2026

Expected to finish

Apr 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Up to 100 patients from the full-monitoring arm of the DISRUPT-AF Registry

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

atrial fibrillation

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Atrial fibrillation (AF)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    5 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Allegheny General Hospital

    NOT_YET_RECRUITING

    Pittsburgh, Pennsylvania, 15212, United States

  • Arrhythmia Center of South Florida

    RECRUITING

    Delray Beach, Florida, 33484, United States

  • HCA Research Institute (FL Mercy Miami)

    NOT_YET_RECRUITING

    Miami, Florida, 37133, United States

  • St. Mark's Hospital

    NOT_YET_RECRUITING

    Salt Lake City, Utah, 84124, United States

  • University of Iowa Hospitals and Clinics

    NOT_YET_RECRUITING

    Iowa City, Iowa, 52242, United States

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