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Single Chamber Atrial Leadless Pacing for Isolated Sinus Node Dysfunction
Sponsor: Northwell Health
Summary
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.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
50
Start Date
2026-05-18
Completion Date
2029-12-31
Last Updated
2026-06-10
Healthy Volunteers
No
Conditions
Interventions
Implantable Loop Recorder
Implantation of a loop recorder in subjects with sick sinus syndrome and normal atrioventricular conduction who are receiving an atrial leadless pacemaker as standard of care.
Locations (6)
South Shore University Hospital
Bay Shore, New York, United States
Huntington Hospital
Huntington, New York, United States
North Shore University Hospital
Manhasset, New York, United States
Long Island Jewish Medical Center
New Hyde Park, New York, United States
Lenox Hill Hospital
New York, New York, United States
Staten Island University Hospital
Staten Island, New York, United States