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NCT Number: NCT07344961

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

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.

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Key information

Conditions

Paroxysmal Atrial Fibrillation Arrhythmias, Cardiac Atrial Fibrillation Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Micra AV2- Observational

Device

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.

Primary outcomes

  1. To evaluate the prevalence of atrial fibrillation in the Micra AV2 patients

    Time frame: Through study completion, an average of 6 months

  2. To evaluate A4 amplitude trend changes during sinus rhythm and atrial fibrillation

    Time frame: Through study completion, an average of 6 months

    To evaluate 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 episodes of sinus rhythm and atrial fibrillation.

  3. To determine the ability of the Micra AV2 device to detect the presence and burden of atrial fibrillation

    Time frame: Through study completion, an average of 6 months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Emma Grace Lao

CONTACT

[email protected]

516-881-7037

Salome Elia Reddy, PhD

CONTACT

[email protected]

516-600-1459

Sponsors and collaborators

Lead sponsor

Northwell Health

Other

Registry information

Acronym: DANCE AFIB

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jan 15, 2026
Registry last updated
Feb 4, 2026

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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