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Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Recruiting Locations

South Shore University Hospital
Bay Shore, New York 11706
Contact:
Rachel Gentles
rgentles1@northwell.edu

Huntington Hospital
Huntington, New York 11743
Contact:
Jane Hubert
jhubert@northwell.edu

North Shore University Hospital
Manhasset, New York 11030
Contact:
Salome Elia Reddy
seliareddy@northwell.edu

Long Island Jewish Medical Center
New Hyde Park, New York 11040
Contact:
Salome Elia Reddy
seliareddy@northwell.edu

Lenox Hill Hospital
New York, New York 10075
Contact:
Kristie Coleman
kcoleman1@northwell.edu

Staten Island University Hospital
Staten Island, New York 10305
Contact:
Alexandra Pantea
apantea@northwell.edu

More Details

Status
Recruiting
Sponsor
Northwell Health

Study Contact

Salome Elia Reddy
516-881-7067
seliareddy@northwell.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.