BOdygUardian MOnitoriNg for ReCurrencE of AF
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: BodyGuardian.
- Who it may be relevant to
- Registry conditions: Atrial Fibrillation (AF). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
BOdygUardian MOnitoriNg for ReCurrencE of AF (BOUNCE-AF)
Overview
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.
Interventions
- Device BodyGuardian
BodyGuardian wear at 6 months
Primary outcome measures
- Primary Objectives [Time frame: From enrollment to the end of BodyGuardian wear at 6 months]
Eligibility criteria
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
1\. Known allergy to adhesives that would contraindicate wearing BodyGuardian
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 3 centers
- Arrhythmia Center of South Florida — Delray Beach
- Allegheny General Hospital — Pittsburgh
- St. Mark's Hospital — Salt Lake City
Identifiers
NCT: NCT07671677 · CTP-28