NCT07638995Recruiting
Single Chamber Atrial Leadless Pacing for Isolated Sinus Node Dysfunction
Northwell Health
Start Date
5/18/2026
Completion Date
12/31/2029
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.
Eligibility Criteria
Age Range: 18 years to No maximum
Inclusion Criteria:
1. Symptomatic sinus bradycardia
2. Sino-atrial exit block
3. Symptomatic sinus arrest with sinus pauses \> 2 sec during waking hours
4. Symptomatic sinus bradycardia \< 40 bpm for \> 1 min during waking hours
5. PR interval ≤ 0.22 sec if aged \< 70 years or PR interval ≤ 0.26 sec if aged ≥ 70 years
6. QRS width ≤ 0.12 sec
7. No prior PM implantation
8. Patients willing to receive an Assert-IQ loop recorder for research purposes
Exclusion Criteria:
1. Atrioventricular block
2. Bundle branch block
3. History of atrial fibrillation
4. Carotid sinus hypersensitivity
5. Planned cardiac surgery
6. Estimated life expectancy \< 1 year
7. Presence of an existing ventricular pacemaker or implantable cardioverter defibrillator
8. Known acute deep vein thrombosis of either lower extremity
9. Unable to read or write
10. Patient with Limited English Proficiency (LEP)
11. Cognitively impaired individuals
12. Pregnant
Interventions
DEVICE
Implantable Loop Recorder
Conditions
Atrial Fibrillation
Locations
South Shore University Hospital
Bay Shore, New York 11706
United States
Huntington Hospital
Huntington, New York 11743
United States
North Shore University Hospital
Manhasset, New York 11030
United States
Long Island Jewish Medical Center
New Hyde Park, New York 11040
United States
Lenox Hill Hospital
New York, New York 10075
United States
Staten Island University Hospital
Staten Island, New York 10305
United States