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BOdygUardian MOnitoriNg for ReCurrencE of AF

NCT07671677 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2026-08-27

No results posted yet for this study

Summary

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.

Conditions

  • Atrial Fibrillation (AF)

Interventions

DEVICE

BodyGuardian

BodyGuardian wear at 6 months

Sponsors & Collaborators

  • Boston Scientific Corporation

    collaborator INDUSTRY

  • Heart Rhythm Clinical and Research Solutions, LLC

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-13
Primary Completion
2028-01-31
Completion
2028-04-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07671677 on ClinicalTrials.gov