BodyGuardian
DeviceBodyGuardian wear at 6 months
NCT Number: NCT07671677
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Observational
Arrhythmia Center of South Florida, Delray Beach, Florida, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Patients must meet all the following criteria to be eligible for inclusion in the BOUNCE-AF sub-study:
Clinical staff willing to consent to complete surveys must meet one of the following requirements:
Exclusion criteria
BodyGuardian wear at 6 months
Time frame: 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.
Contact information is provided by the study sponsor or research team.
Kayla Oliver
CONTACT
Megan Goodfellow
CONTACT
Heart Rhythm Clinical and Research Solutions, LLC
Other
BOdygUardian MOnitoriNg for ReCurrencE of AF (BOUNCE-AF)
Acronym: BOUNCE-AF
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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