NCT07671677 BOdygUardian MOnitoriNg for ReCurrencE of AF
| NCT ID | NCT07671677 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Heart Rhythm Clinical and Research Solutions, LLC |
| Condition | Atrial Fibrillation (AF) |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2026-08-13 |
| Primary Completion | 2028-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2026-08-13 with a primary completion date of 2028-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07671677 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Atrial Fibrillation (AF). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07671677 currently recruiting?
Yes, NCT07671677 is actively recruiting participants. Contact the research team at koliver@hrcrs.com for enrollment information.
Where is the NCT07671677 trial being conducted?
This trial is being conducted at Delray Beach, United States, Miami, United States, Iowa City, United States, Pittsburgh, United States and 1 additional location.
Who is sponsoring the NCT07671677 clinical trial?
NCT07671677 is sponsored by Heart Rhythm Clinical and Research Solutions, LLC. The trial plans to enroll 100 participants.
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