NCT07344961Recruiting
Determinates of Atrial Tracking and Prevalence of Atrial Fibrillation in the Micra AV2 (DANCE AFIB)
Source: ClinicalTrials.gov · Last updated 4 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 50 (estimated)
- First submitted
- 10 Dec 2025
- Start date
- 29 Dec 2025
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- Northwell Health
- Diseases
- Atrial fibrillation
- NCT number
- NCT07344961
What you commit to
- Study type: Observational
- Planned participants: 50
- From 29 Dec 2025 to the primary completion date, 31 Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Participant is currently enrolled or plans to enroll in concurrent drug/device study that may confound the study results
Other
- Participant who is, or is expected to be, inaccessible for follow-up
- Participation is excluded by local law
- 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.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Long Island Jewish Medical Center Coordinator of this site? Confirm its status | New Hyde Park | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.