Study of Atrial Tracking and Atrial Fibrillation in Patients Receiving the Micra AV2 Device

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 physicians 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.

Determinates of Atrial Tracking and Prevalence of Atrial Fibrillation in the Micra AV2 (DANCE AFIB)