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Observational Study of Micra AV2 in Patients with Atrial Fibrillation

This study is looking at how well the Micra AV2 device works in people who have paroxysmal atrial fibrillation (a type of irregular heartbeat that comes and goes). Researchers want to understand how often atrial fibrillation occurs in patients with the Micra AV2 device and how well the device can detect these irregular heartbeats. They will also look at changes in heart signals during normal rhythm and during atrial fibrillation. You may be able to join if you have a history of paroxysmal atrial fibrillation and are getting or already have a Micra AV2 device as part of your usual medical care within the Northwell Health System. The study aims to understand how the device performs over about 6 months.

Study design
This is an observational study involving about 50 participants. It is designed to describe what happens with the Micra AV2 device in real-world settings.
What's involved
Periodic device checks will be reviewed. The study will follow participants for an average of 6 months.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed through study completion, which is an average of 6 months.

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NCT07344961

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

Recruiting
Not specifiedAges 18+Observational
Northwell Health
~50 participants
Updated 2026-02-04 on ClinicalTrials.gov
What's tested:Micra AV2- Observational

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
To evaluate the prevalence of atrial fibrillation in the Micra AV2 patients
Measured over Through study completion, an average of 6 months
+2 more outcomes measured

Conditions

Paroxysmal Atrial Fibrillation

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Paroxysmal Atrial Fibrillation

NCT07344961

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Long Island Jewish Medical Center

    New Hyde Park, New Yorkstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Haisam Ismail, MD · PRINCIPAL_INVESTIGATOR · Northwell Health

Who to contact

Salome Elia Reddy, PhD
[email protected]
516-600-1459
Email the study team

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • To evaluate the prevalence of atrial fibrillation in the Micra AV2 patientsThrough study completion, an average of 6 months
  • To evaluate A4 amplitude trend changes during sinus rhythm and atrial fibrillationThrough 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.

  • To determine the ability of the Micra AV2 device to detect the presence and burden of atrial fibrillationThrough 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.