Factors that affect atrial tracking and atrial fibrillation in people receiving the Micra AV2 pacemaker

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.