Single Chamber Atrial Leadless Pacing for Isolated Sinus Node Dysfunction
Recruiting · NCT07638995 · Observational (researchers observe without assigning treatment) · Lead sponsor: Northwell Health
View the official record on ClinicalTrials.gov →Interventions studied
Implantable Loop Recorder
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
Inclusion criteria
- Symptomatic sinus bradycardia
- Sino-atrial exit block
- Symptomatic sinus arrest with sinus pauses \> 2 sec during waking hours
- Symptomatic sinus bradycardia \< 40 bpm for \> 1 min during waking hours
- PR interval ≤ 0.22 sec if aged \< 70 years or PR interval ≤ 0.26 sec if aged ≥ 70 years
- QRS width ≤ 0.12 sec
- No prior PM implantation
- Patients willing to receive an Assert-IQ loop recorder for research purposes
Exclusion criteria
- Atrioventricular block
- Bundle branch block
- History of atrial fibrillation
- Carotid sinus hypersensitivity
- Planned cardiac surgery
- Estimated life expectancy \< 1 year
- Presence of an existing ventricular pacemaker or implantable cardioverter defibrillator
- Known acute deep vein thrombosis of either lower extremity
- Unable to read or write
- Patient with Limited English Proficiency (LEP)
- Cognitively impaired individuals
- Pregnant
Where it is running
6 locations listed across 1 US state.
- South Shore University Hospital - Bay Shore, New York, United States
- Huntington Hospital - Huntington, New York, United States
- North Shore University Hospital - Manhasset, New York, United States
- Long Island Jewish Medical Center - New Hyde Park, New York, United States
- Lenox Hill Hospital - New York, New York, United States
- Staten Island University Hospital - Staten Island, New York, United States