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| Name | Class |
|---|---|
| Abbott | INDUSTRY |
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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Implantable Loop Recorder | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of atrial fibrillation | Incidence of atrial fibrillation in patients implanted with a single chamber (Aveir AR, Abbott) leadless pacemaker and a loop recorder. | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Composite incidence of a newly prolonged PR interval | 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 | 24 months |
| Need for system upgrade from a single chamber to dual chamber |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Salome Elia Reddy | Contact | 516-881-7067 | seliareddy@northwell.edu |
| Name | Affiliation | Role |
|---|---|---|
| James Gabriels, MD | Northwell Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| South Shore University Hospital | Recruiting | Bay Shore | New York | 11706 | United States |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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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. |
| 24 months |
| Battery Longevity | 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. | 24 months |
| Huntington Hospital | Recruiting | Huntington | New York | 11743 | United States |
|
| North Shore University Hospital | Recruiting | Manhasset | New York | 11030 | United States |
|
| Long Island Jewish Medical Center | Recruiting | New Hyde Park | New York | 11040 | United States |
|
| Lenox Hill Hospital | Recruiting | New York | New York | 10075 | United States |
|
| Staten Island University Hospital | Recruiting | Staten Island | New York | 10305 | United States |
|
| D013568 |
| Pathological Conditions, Signs and Symptoms |