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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

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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