Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| G240218 | Other Identifier | FDA IDE Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The primary objective of this study is to evaluate the safety and effectiveness of Abbott's Amulet™ 2 Left Atrial Appendage (LAA) occluder device (Amulet 2 device) in patients who have non-valvular atrial fibrillation and who are at increased risk for stroke and systemic embolism and have appropriate rationale to seek a non-pharmacologic alternative to oral anticoagulation.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Amulet™ 2 Left Atrial Appendage (LAA) Occluder | Experimental | Transcatheter left atrial appendage (LAA) occluder |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Amulet™ 2 Left Atrial Appendage (LAA) Occluder | Device | Patient will undergo the implantation of the Amulet™ 2 Left Atrial Appendage (LAA) Occluder |
|
| Measure | Description | Time Frame |
|---|---|---|
| The primary safety endpoint is the occurrence of any prespecified safety events through 7 days post-procedure or hospital discharge, whichever is later. | The primary safety endpoint is the occurrence of any of the following events through 7 days post-procedure or hospital discharge, whichever is later: death, ischemic stroke, systemic embolism, or device/procedure related complications requiring open cardiac surgery or major endovascular intervention. Device/procedure related events contributing to the primary endpoint may include pseudoaneurysm or AV fistula repair, whereas percutaneous drainage of pericardial effusion, snaring of embolized devices, thrombin injection or nonsurgical treatment of access site complications will not contribute to the primary endpoint. | 7 days post-procedure or hospital discharge |
| The primary effectiveness endpoint is LAA occlusion defined as no peri-device flow or peri-device flow ≤5mm based on TEE/TOE at the 45-day follow-up visit. | The primary effectiveness endpoint is LAA occlusion defined as no peri-device flow or peri-device flow ≤5mm based on Doppler color flow TEE/TOE at the 45-day follow-up visit as assessed by an independent core laboratory. | 45 days |
| Measure | Description | Time Frame |
|---|---|---|
| The secondary effectiveness endpoint is the composite of ischemic stroke or systemic embolism at 24 months. | The secondary effectiveness endpoint is the composite of ischemic stroke or systemic embolism at 24 months. | 24 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Anatomical Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Ryan Palmer | Abbott Medical | Study Director |
| Devi Nair, MD | Arrhythmia Research Group | Principal Investigator |
| Mohamad Alkhouli, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona Arrhythmia Research Group | Phoenix | Arizona | 85016 | United States | ||
| Arrhythmia Research Group |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41701134 | Derived | Nair D, Freixa X, Ellis CR, Lakkireddy D, Nielsen-Kudsk JE, Horton R, Reddy VY, Makkar A, Ibrahim R, Agarwal H, de Backer O, Sabir S, Weiler C, Alkhouli M; VERITAS Investigators. Early Outcomes With a Next-Generation Dual-Seal Left Atrial Appendage Occluder: Results From the VERITAS Study. JACC Clin Electrophysiol. 2026 Jun;12(6):1331-1341. doi: 10.1016/j.jacep.2026.01.021. Epub 2026 Feb 6. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Jonesboro |
| Arkansas |
| 72401 |
| United States |
| Baptist Medical Center | Jacksonville | Florida | 32207 | United States |
| AdventHealth Orlando | Orlando | Florida | 32803 | United States |
| Northside Hospital | Atlanta | Georgia | 30342 | United States |
| Kansas City Cardiac Arrhythmia Research Foundation | Overland Park | Kansas | 66211 | United States |
| Henry Ford Providence Southfield Hospital | Southfield | Michigan | 48075 | United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| CHI Health Creighton University Medical Center-Bergan Mercy | Omaha | Nebraska | 68124 | United States |
| NYU Langone Health | New York | New York | 10016 | United States |
| Mount Sinai Hospital | New York | New York | 10019 | United States |
| Roper Hospital | Charleston | South Carolina | 29401 | United States |
| Trident Medical Center | Charleston | South Carolina | 29406 | United States |
| Vanderbilt Heart & Vascular Institute | Nashville | Tennessee | 37232 | United States |
| Texas Cardiac Arrhythmia | Austin | Texas | 78705 | United States |
| Baylor Scott & White All Saints Medical Center | Fort Worth | Texas | 76104 | United States |
| Vital Heart and Vein | Humble | Texas | 77338 | United States |
| Baylor Scott & White - The Heart Hospital Plano | Plano | Texas | 75093 | United States |
| Heart Rhythm Associates | Shenandoah | Texas | 77380 | United States |
| Hôpital Civil Marie Curie | Lodelinsart | Belgium |
| University of Ottawa Heart Institute | Ottawa | Ontario | K18 4W7 | Canada |
| Institut de Cardiologie de Montreal (Montreal Heart Inst.) | Montreal | Quebec | Canada |
| Aarhus Universitetshospital | Aarhus | Denmark |
| Rigshospitalet | Copenhagen | Denmark |
| CHU Gabriel Montpied | Clermont-Ferrand | Auvergn | France |
| Institute Cardio. Paris-Sud - Institut Jacques Cartier | Massy | France |
| Cardioangiologisches Centrum am Bethanien Krankenhaus | Frankfurt am Main | Hesse | Germany |
| Deutsches Herzzentrum der Charité | Berlin | Germany |
| Universitätsklinikum Schleswig-Holstein - Campus Lübeck | Lübeck | Germany |
| Heinrich-Braun-Klinikum gemeinnützige gGmbH Standort Zwickau | Zwickau | Germany |
| Ospedale San Raffaele | Milan | Italy |
| Hospital Clínic de Barcelona | Barcelona | Spain |
| Hospital Clinico San Carlos | Madrid | Spain |
| Hospital Universitario de Salamanca | Salamanca | Spain |
| Center Inselspital Bern | Bern | Canton of Bern | Switzerland |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided