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โ† Trials
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BOdygUardian MOnitoriNg for ReCurrencE of AF

Recruitingn/aAges 18 Years - anyAllHeart Rhythm Clinical and Research Solutions, LLC
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In plain words

What the trial is, and whether it could suit you

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 monit

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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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What it tests

  • BodyGuardian
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Where

5 sites
Arrhythmia Center of South Florida
Delray Beach, United States
HCA Research Institute (FL Mercy Miami)
Miami, United States
University of Iowa Hospitals and Clinics
Iowa City, United States
Allegheny General Hospital
Pittsburgh, United States
St. Mark's Hospital
Salt Lake City, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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