Single Chamber Atrial Leadless Pacing for Isolated Sinus Node Dysfunction
The study aims to evaluate the following: 1) the incidence of new onset atrial fibrillation in patients with an atrial leadless pacemaker, 2) the need for upgrade from a standalone atrial leadless pacemaker to a dual chamber leadless pacemaker system, and 3) to compare the battery longevity of the Aveir AR at two years with the battery longevity of subjects implanted with dual chamber leadless pacemakers in the Aveir DR i2i study.
• Symptomatic sinus bradycardia
• Sino-atrial exit block
• Symptomatic sinus arrest with sinus pauses \> 2 sec during waking hours
• Symptomatic sinus bradycardia \< 40 bpm for \> 1 min during waking hours
• PR interval ≤ 0.22 sec if aged \< 70 years or PR interval ≤ 0.26 sec if aged ≥ 70 years
• QRS width ≤ 0.12 sec
• No prior PM implantation
• Patients willing to receive an Assert-IQ loop recorder for research purposes