Actively Recruiting

Age: 18Years +
All Genders
NCT07344961

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

Led by Northwell Health · Updated on 2026-02-04

50

Participants Needed

1

Research Sites

104 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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 atrial fibrillation. Patients who have atrial fibrillation during index hospitalization will undergo placement of the Medtronic Holter monitor as part of the standard of care index hospitalization. Eligible outpatients will undergo placement of the Medtronic Research Holter Monitor in the office.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Participant or legally authorized representative provides consent per institution and geographical requirements
  • Participant has been or will be implanted with the Micra AV2 device as part of standard care
  • Participant has a history of paroxysmal atrial fibrillation and is undergoing Micra AV2 implantation
  • Age between 18 and 85 years old and able to consent to the procedure
  • Participant is consented within the enrollment window related to therapy received
  • Participant is English speaking
Not Eligible

You will not qualify if you...

  • Participant is or is expected to be inaccessible for follow-up
  • Participation is prohibited by local law
  • Participant is currently enrolled or plans to enroll in another drug or device study that could affect results
  • Participant has persistent or chronic atrial fibrillation
  • Participant is a prisoner or cognitively impaired and unable to independently wear the Holter monitor for research

AI-Screening

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Trial Site Locations

Total: 1 location

1

Long Island Jewish Medical Center

New Hyde Park, New York, United States, 11040

Actively Recruiting

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Research Team

S

Salome Elia Reddy, PhD

CONTACT

E

Emma Grace Lao

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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