Home › Atrial Fibrillation › NCT07638995
Single Chamber Atrial Leadless Pacing for Isolated Sinus Node Dysfunction
RecruitingObservational study
Who can join
Ages 18 and older · All sexes
Full eligibility criteria
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
About the study
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.
What is being tested
- Implantable Loop Recorder (device)
Sponsor: Northwell Health · Participants: 50 · Started: May 18, 2026
Contact the study team
- Salome Elia Reddy · Phone: 516-881-7067
Official record on ClinicalTrials.gov — NCT07638995
Locations in the U.S.
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.