BOdygUardian MOnitoriNg for ReCurrencE of AF

Part of paid clinical trials in Delray Beach, Florida.

Sponsor
Heart Rhythm Clinical and Research Solutions, LLC
Study ID
NCT07671677
Status
Recruiting
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Conditions

  • Atrial Fibrillation (AF)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • BodyGuardian — DEVICE
    BodyGuardian wear at 6 months

Study Details

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.

Key Dates

First listed
Jun 26, 2026
Start date
Aug 13, 2026
Status verified
Jun 2026
Primary completion
Jan 31, 2028
Completion
Apr 30, 2028

Study Design

Enrollment
100 participants (estimated)

Primary Outcome Measure

Primary Objectives [ Time Frame: From enrollment to the end of BodyGuardian wear at 6 months ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
Arrhythmia Center of South FloridaDelray BeachFlorida33484
Julianna Restrepo
[email protected]
Alexandra "Ali" Beaumont
[email protected]
(561) 303 -3491
Yoel Vivas (PRINCIPAL_INVESTIGATOR)
Luis Mora (SUB_INVESTIGATOR)
Mark Freher (SUB_INVESTIGATOR)
HCA Research Institute (FL Mercy Miami)MiamiFlorida37133
Ana Portela
[email protected]
305-285-2976
Jose Osorio (PRINCIPAL_INVESTIGATOR)
University of Iowa Hospitals and ClinicsIowa CityIowa52242
Trisha Elliott
[email protected]
319-384-1628
Paari Dominic (PRINCIPAL_INVESTIGATOR)
Allegheny General HospitalPittsburghPennsylvania15212
Caitlin Phalunas
[email protected]
412-359-3457
St. Mark's HospitalSalt Lake CityUtah84124
Sherry Fisher

Find similar trials in Delray Beach, FL

By research site
Arrhythmia Center of South Florida· Delray Beach, FLHCA Research Institute (FL Mercy Miami)· Miami, FLUniversity of Iowa Hospitals and Clinics· Iowa City, IAAllegheny General Hospital· Pittsburgh, PASt. Mark's Hospital· Salt Lake City, UT

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