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| ID | Type | Description | Link |
|---|---|---|---|
| CRD_1056 | Other Identifier | Abbott Medical Devices |
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This is a prospective, multicenter, observational study intended to characterize real-world outcomes on the commercially available Amulet device in the United States. Over 600 subjects have been enrolled at 16 US clinical sites. Subjects will be followed through 24 months in accordance with each site's standard care practices.
The ADVANCE LAA study is intended to characterize real-world outcomes of patients receiving the commercially available Amulet device in the United States. The Amulet device is intended to reduce the risk of thrombus embolization from the left atrial appendage (LAA) in patients who have nonvalvular atrial fibrillation (NVAF) and who are at increased risk for stroke and systemic embolism based on CHADS2 or CHA2DS2-VASc scores, are suitable for short-term anticoagulation therapy, and have appropriate rationale to seek a non-pharmacologic alternative to oral anticoagulation, taking into consideration the safety and effectiveness of the device.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Left atrial appendage occlusion (LAAO) | Device | Implantation of an Amplatzer Amulet left atrial appendage occluder |
| Measure | Description | Time Frame |
|---|---|---|
| Composite endpoint: Death or complications | Composite of all-cause death, ischemic stroke, systemic embolism, or device/procedure related complications requiring an invasive surgical or percutaneous intervention within 7 days of implant or hospital discharge, whichever is later | Within 7 days of implant or hospital discharge, whichever is later |
| Device closure, defined as residual jet around the device ≤ 3mm | Device closure (defined as residual jet around the device ≤ 3mm) at the first follow-up visit documented by trans-esophageal echocardiography (TEE), as assessed by an independent core laboratory | Assessed at first trans-esophageal echocardiogram (TEE) occurring between 30-240 days post-implant. |
| Composite endpoint: Ischemic stroke or systemic embolism | Composite of ischemic stroke or systemic embolism through 24 months | Through 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with non-valvular atrial fibrillation who are at increased risk for ischemic stroke or systemic embolism.
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| Name | Affiliation | Role |
|---|---|---|
| Dhanunjaya Lakkireddy, MD | Kansas City Cardiac Arrhythmia Research Foundation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona Arrhythmia Research | Phoenix | Arizona | 85016 | United States | ||
| Arkansas Heart Hospital |
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| Little Rock |
| Arkansas |
| 72211 |
| United States |
| Baptist Medical Center | Jacksonville | Florida | 32207 | United States |
| Usman R. Siddiqui, MD | Winter Park | Florida | 32792 | United States |
| PERC - O'Fallon | O'Fallon | Illinois | 62269 | United States |
| Kansas City Cardiac Arrhythmia Research Foundation | Overland Park | Kansas | 66211 | United States |
| Cardiovascular Research Institute of Kansas | Wichita | Kansas | 67226 | United States |
| Providence Hospital | Southfield | Michigan | 48075 | United States |
| Bryan Heart | Lincoln | Nebraska | 68506 | United States |
| CHI Health Creighton University Medical Center-Bergan Mercy | Omaha | Nebraska | 68124 | United States |
| New York University Hospital | New York | New York | 10016 | United States |
| Pinnacle Health System | Mechanicsburg | Pennsylvania | 17150 | United States |
| Trident Medical Center | Charleston | South Carolina | 29406 | United States |
| Vanderbilt Heart & Vascular Institute | Nashville | Tennessee | 37232 | United States |
| Baylor All Saints Medical Center at Fort Worth | Fort Worth | Texas | 76104 | United States |
| Heart Rhythm Associates | Shenandoah | Texas | 77380 | United States |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D020521 | Stroke |
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D000097546 | Left Atrial Appendage Closure |
| ID | Term |
|---|---|
| D006328 | Cardiac Catheterization |
| D002404 | Catheterization |
| D013812 | Therapeutics |
| D008919 | Investigative Techniques |
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