Recruiting

PFA System

Sponsor:

Heart Rhythm Clinical and Research Solutions, LLC

Code:

NCT07671677

Conditions

Atrial Fibrillation (AF)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

BodyGuardian

Study Details

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.

Conditions

Atrial Fibrillation (AF)

Study ID

NCT07671677

Start date

Aug 13, 2026

Status verified date

Jun, 2026

Completion date

Apr, 2028

Anticipated

Primary completion date

Jan, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Interventions

BodyGuardian

BodyGuardian wear at 6 months

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Locations

Arrhythmia Center of South Florida

Recruiting

Delray Beach, Florida, United States, 33484

Contacts

Julianna Restrepo

julianna@vivasmd.com

Alexandra "Ali" Beaumont

(561) 303 -3491ali@vivasmd.com

Principal Investigator:

Yoel Vivas

More Information

Sponsor

Heart Rhythm Clinical and Research Solutions, LLC

Last update posted

Aug 27, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Heart Rhythm Clinical and Research Solutions, LLC on 2026-08-27.