RecruitingNCT07344961

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


Sponsor

Northwell Health

Enrollment

50 participants

Start Date

Dec 29, 2025

Study Type

OBSERVATIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is following people who have received or are receiving a very small wireless pacemaker called Micra AV2 — a device implanted directly in the heart with no wires (leads). Researchers want to understand how well the device tracks the upper chambers of the heart and how common an irregular heartbeat called atrial fibrillation (AFib) is in this group of patients. **You may be eligible if...** - You are 18–85 years old - You have received or are scheduled to receive the Micra AV2 wireless pacemaker - You have a history of paroxysmal (comes and goes) atrial fibrillation - You can speak English and provide consent **You may NOT be eligible if...** - You are likely to be lost to follow-up - You have permanent or persistent atrial fibrillation (AFib that does not go away) - You are currently in another study that could affect results - You are a prisoner or have cognitive impairment that prevents you from independently wearing a heart monitor Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEMicra AV2- Observational

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.


Locations(1)

Long Island Jewish Medical Center

New Hyde Park, New York, United States

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NCT07344961


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