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Determinates of Atrial Tracking and Prevalence of Atrial Fibrillation in the Micra AV2 (DANCE AFIB)

Recruitingn/aAges 18 Years - anyAllNorthwell Health
NCT07344961 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

This is a prospective, descriptive study. Safety endpoints will not be assessed. All eligible patients that have a history of paroxysmal atrial fibrillation and an indication to undergo Micra AV2 device placement as per standard of care (SOC) across the participating sites within the Northwell Health System can be included in this analysis. Micra AV2 placement indications will be at the discretion of the treating electrophysiologist, but are expected to be predominantly atrioventricular block. Periodic device interrogations will be reviewed for the presence of effective atrial tracking during sinus rhythm . The presence of paroxysmal atrial fibrillation and the degree to which atrial activity and A4 amplitude trend changes will be assessed using a designated Medtronic Research Holter monitor that detects Micra AV2 signals at any point in the study during a episodes of sinus rhythm and at

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📋 Eligibility rules (as published)
Inclusion Criteria: * Participant or legally authorized representative (LAR) provides authorization and/or consent per institution and geographical requirements * Participant has been implanted with the Micra AV2 device or is intended to receive or be treated with an eligible Micra AV2 device as per standard of care. * Participants with a history of paroxysmal atrial fibrillation undergoing Micra AV2 implantation, as per standard of care. * Age 18-85 years old with the ability to consent for the procedure * Participant is consented within the enrollment window of the therapy received, as applicable * English Speaking Exclusion Criteria: * Participant who is, or is expected to be, inaccessible for follow-up * Participation is excluded by local law * Participant is currently enrolled or plans to enroll in concurrent drug/device study that may confound the study results * Participant with persistent/chronic atrial fibrillation * Prisoner or cognitively impaired due to the study procedures involving independent wearing of the holter monitor for research purposes.
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What it tests

  • Micra AV2- Observational
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Where

1 site
Long Island Jewish Medical Center
New Hyde Park, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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