NCT07344961 · Northwell Health
Determinates of Atrial Tracking and Prevalence of Atrial Fibrillation in the Micra AV2 (DANCE AFIB)
(DANCE AFIB)
What this study is about
This is a forward-looking, 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 the usual treatment (SOC) across the participating sites within the Northwell Health System can be included in this analysis.
View original scientific description
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.
Interventions
DEVICE
Micra 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.
Primary outcome measures
To evaluate the prevalence of atrial fibrillation in the Micra AV2 patients
Time frame: Through study completion, an average of 6 months
To evaluate A4 amplitude trend changes during sinus rhythm and atrial fibrillation
Time frame: Through 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 fibrillation
Time frame: Through 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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 criteria
- 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.
Where
- New Hyde Park, New York
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 4, 2026 · Source of record for eligibility and locations