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

Part of paid clinical trials in New Hyde Park, New York.

Sponsor
Northwell Health
Study ID
NCT07344961
Status
Recruiting
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Conditions

  • Paroxysmal Atrial Fibrillation

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Dec 29, 2025
Status verified
Feb 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
50 participants (estimated)

Primary Outcome Measure

To evaluate the prevalence of atrial fibrillation in the Micra AV2 patients [ Time Frame: Through study completion, an average of 6 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Long Island Jewish Medical CenterNew Hyde ParkNew York11040
Salome Elia Reddy, PhD
[email protected]
516-600-1459
Emma Grace Lao
[email protected]
516-881-7037

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By research site
Long Island Jewish Medical Center· New Hyde Park, NY

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