Evaluation of Single Chamber Atrial Leadless Pacemaker Use in Adults with Sinus Node Dysfunction Monitoring Atrial Fibrillation, Device Upgrades, and Battery Longevity

What this Trial Is About

Researchers are studying adults with sinus node dysfunction who receive a single chamber atrial leadless pacemaker to understand several important outcomes. The study evaluates the rate of new atrial fibrillation occurring in these patients, the need to upgrade from a single chamber atrial leadless pacemaker to a dual chamber system, and compares the battery life of the Aveir AR pacemaker at two years with that of dual chamber leadless pacemakers from another study. This observational study is sponsored by Northwell Health and is focused on patients with specific heart rhythm conditions. Participants receive standard care including implantation of an atrial leadless pacemaker and an implantable loop recorder device for continuous heart rhythm monitoring. The loop recorder helps detect atrial fibrillation and other heart conduction changes over time. The study does not involve experimental treatments but closely observes patients with this device for up to 24 months to assess device performance and clinical outcomes. During the study, participants will be monitored for the development of atrial fibrillation, changes in heart conduction intervals, and any need to upgrade their pacemaker system. Battery longevity of the device will also be tracked over two years. Data collection includes heart rhythm recordings from the loop recorder and clinical assessments. Participants progress is followed regularly to measure these outcomes and ensure safety throughout the study period, which lasts until the end of 2029.

Single Chamber Atrial Leadless Pacing for Isolated Sinus Node Dysfunction