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.
Study Type
OBSERVATIONAL
Enrollment
50
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.
South Shore University Hospital
Bay Shore, New York, United States
RECRUITINGHuntington Hospital
Huntington, New York, United States
RECRUITINGNorth Shore University Hospital
Manhasset, New York, United States
Incidence of atrial fibrillation
Incidence of atrial fibrillation in patients implanted with a single chamber (Aveir AR, Abbott) leadless pacemaker and a loop recorder.
Time frame: 24 months
Composite incidence of a newly prolonged PR interval
Composite incidence of a newly prolonged PR interval \>/= 300ms or a need for system upgrade from a single chamber (Aveir AR, Abbott) leadless pacemaker to a dual chamber leadless pacemaker (Aveir DR, Abbott) at two-years
Time frame: 24 months
Need for system upgrade from a single chamber to dual chamber
Need for system upgrade from a single chamber (Aveir AR, Abbott) leadless pacemaker to a dual chamber leadless pacemaker (Aveir DR, Abbott) at two-years.
Time frame: 24 months
Battery Longevity
Remaining battery longevity of the single chamber leadless atrial pacemaker (Aveir, AR) compared with remaining battery longevity of subjects in the Aveir DR i2i study implanted with a dual chamber leadless pacemaker with comparable percentages of atrial pacing without ventricular pacing.
Time frame: 24 months
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Long Island Jewish Medical Center
New Hyde Park, New York, United States
RECRUITINGLenox Hill Hospital
New York, New York, United States
RECRUITINGStaten Island University Hospital
Staten Island, New York, United States
RECRUITING