Factors that affect atrial tracking and atrial fibrillation in people receiving the Micra AV2 pacemaker
Determinates of Atrial Tracking and Prevalence of Atrial Fibrillation in the Micra AV2 (DANCE AFIB)
This will see how well the Micra AV2 device tracks atrial activity and how often short episodes of paroxysmal atrial fibrillation occur in adults who receive the device.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Northwell Health Academic / other |
| Locations | 1 site (New Hyde Park, New York) |
| Trial ID | NCT07344961 on ClinicalTrials.gov |
What this trial studies
This prospective, descriptive observational study enrolls adults with a history of paroxysmal atrial fibrillation who are receiving a Micra AV2 pacemaker as part of standard care at Northwell Health. Investigators will perform periodic device interrogations and use a designated Medtronic research Holter monitor to capture Micra AV2 signals during sinus rhythm and during episodes of atrial fibrillation. The study will track the presence and effectiveness of atrial tracking, including atrial activity and A4 amplitude trends, over time but will not include formal safety endpoint assessments. Patients with persistent or chronic atrial fibrillation are excluded, and enrollment is limited to consenting English-speaking adults aged 18–85 who can complete follow-up.
Who should consider this trial
Good fit: Ideal candidates are English-speaking adults aged 18–85 with a history of paroxysmal atrial fibrillation who are receiving a Micra AV2 pacemaker per standard clinical care and can attend follow-up.
Not a fit: Patients with persistent or chronic atrial fibrillation, those unable to complete follow-up, or those enrolled in conflicting device/drug studies are unlikely to benefit from the study's findings.
Why it matters
Potential benefit: If successful, the results could help doctors identify which patients are most likely to get reliable atrial tracking from Micra AV2 and improve device programming and follow-up.
How similar studies have performed: Previous studies of Micra AV devices have shown that mechanical atrial sensing can work in many patients, but Micra AV2-specific data on atrial tracking in paroxysmal atrial fibrillation remains limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
New Hyde Park, New York
- Long Island Jewish Medical Center — New Hyde Park, New York, United States (Recruiting)
Study contacts
- Principal investigator: Haisam Ismail, MD — Northwell Health
- Study coordinator: Salome Elia Reddy, PhD
- Email: seliareddy@northwell.edu
- Phone: 516-600-1459
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.