Atrial Fibrillation
Conditions
Brief 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.
Interventions
DEVICEImplantable Loop Recorder
Implantation of a loop recorder in subjects with sick sinus syndrome and normal atrioventricular conduction who are receiving an atrial leadless pacemaker as standard of care.
Sponsors
Northwell Health
Abbott
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of atrial fibrillation | 24 months | Incidence of atrial fibrillation in patients implanted with a single chamber (Aveir AR, Abbott) leadless pacemaker and a loop recorder. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Composite incidence of a newly prolonged PR interval | 24 months | Composite incidence of a newly prolonged PR interval \>/= 300ms or a need for system upgrade from a single chamber (Aveir AR, Abbott) leadless pacemaker to a dual chamber leadless pacemaker (Aveir DR, Abbott) at two-years |
| Need for system upgrade from a single chamber to dual chamber | 24 months | Need for system upgrade from a single chamber (Aveir AR, Abbott) leadless pacemaker to a dual chamber leadless pacemaker (Aveir DR, Abbott) at two-years. |
| Battery Longevity | 24 months | Remaining battery longevity of the single chamber leadless atrial pacemaker (Aveir, AR) compared with remaining battery longevity of subjects in the Aveir DR i2i study implanted with a dual chamber leadless pacemaker with comparable percentages of atrial pacing without ventricular pacing. |
Countries
United States
Contacts
CONTACTSalome Elia Reddy
PRINCIPAL_INVESTIGATORJames Gabriels, MD
Northwell Health
Outcome results
None listed