Actively Recruiting
Determinants 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
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting a prospective, descriptive study to evaluate patients with a history of paroxysmal atrial fibrillation who are undergoing placement of the Micra AV2 device, primarily for atrioventricular block, as per standard care at participating Northwell Health System sites. The study aims to assess the prevalence of atrial fibrillation, monitor atrial activity, and analyze A4 amplitude trend changes during sinus rhythm and atrial fibrillation episodes. Safety endpoints are not being evaluated in this research. The study involves patients receiving the Micra AV2 device based on their physician's recommendation. Those hospitalized with atrial fibrillation will have a Medtronic Research Holter monitor placed during their hospital stay, while eligible outpatients will receive the Holter monitor in the clinic. This device continuously detects Micra AV2 signals to track atrial activity throughout the study period. Participants will undergo periodic device interrogations to review atrial tracking effectiveness during sinus rhythm. The Medtronic Holter monitor will be used to observe atrial fibrillation presence and burden over approximately six months. The study includes regular follow-ups to measure changes in atrial activity and A4 amplitude trends. Participation is expected to last an average of six months, during which data will be collected through device monitoring and standard clinical visits.
CONDITIONS
Brief Title
Determinates of Atrial Tracking and Prevalence of Atrial Fibrillation in the Micra AV2 (DANCE AFIB)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant or legally authorized representative provides consent as required
- Participant has been implanted with or is intended to receive a Micra AV2 device as per standard care
- History of paroxysmal atrial fibrillation and undergoing Micra AV2 implantation
- Age between 18 and 85 years with ability to consent
- English speaking
- Participant is consented within the enrollment window of the therapy received, if applicable
You will not qualify if you...
- Participant expected to be inaccessible for follow-up
- Participation excluded by local law
- Currently enrolled or plans to enroll in another drug/device study that may affect results
- Participant has persistent or chronic atrial fibrillation
- Prisoner or cognitive impairment preventing use of Holter monitor independently
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 1 day
Participants undergo placement of the Micra AV2 device as part of their standard care.
1 visit (in-person)
Duration - Approximately 6 months
Participants are monitored to evaluate the prevalence and burden of atrial fibrillation using the Micra AV2 device.
Regular device data transmissions with follow-up visits as per routine care
Trial Site Locations
Total: 1 location
1
Long Island Jewish Medical Center
New Hyde Park, New York, United States, 11040
Actively Recruiting
Research Team
S
Salome Elia Reddy, PhD
E
Emma Grace Lao
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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