Atrial Fibrillation (AF)
Conditions
Brief 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.
Interventions
DEVICEBodyGuardian
BodyGuardian wear at 6 months
Sponsors
Heart Rhythm Clinical and Research Solutions, LLC
Boston Scientific Corporation
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Objectives | From enrollment to the end of BodyGuardian wear at 6 months | Results will include arrhythmia recurrence and burden, and subjective data on the patient and clinician experience with BodyGuardian. The study will also evaluate reimbursement patterns for post-ablation monitoring, as well as subject compliance to the physician prescribed monitoring duration. |
Countries
United States
Contacts
CONTACTKayla Oliver
CONTACTMegan Goodfellow
Outcome results
None listed