| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01997905 | Stroke Feasibility Study | PHASE1 | COMPLETED | 13 | — | — | Jan 1, 2014 | Aug 1, 2015 | Dec 14, 2016 | 7 | United States |
The primary safety endpoint consists of the following serious adverse events within 30 days post-index procedure (unless otherwise noted), as adjudicated by Independent Physician Adjudicator: * Serious Injury to the cardiac structure or other body structure deemed to be related to the delivery or placement of the Clip * Cardiac-Related Death, Myocardial Infarction, or Ischemic Stroke * Major bleeding (defined as requiring re-operation and/or transfusion (\> 2 U packed red blood cells (PRBC)) within any 24 hour period during the first 2 days post-index procedure or at any time point if attributed to the device/index procedure).
Primary Efficacy endpoint is a success/failure endpoint with success requiring all of the following: 1. Patient Technical Success: The ability to successfully implant an AtriClip device at the LAA in a patient. 2. Intra-Procedural Complete Exclusion of the LAA: The complete exclusion of the LAA defined by lack of fluid communication (\<3 mm residual communication with LAA and \<10 mm residual pocket) between the LA and LAA, assessed intra-procedurally by TEE. 3. 3 Month Follow-Up Complete Exclusion of the LAA: The complete exclusion of the LAA defined by lack of fluid communication (\<3 mm residual communication with LAA and \< 10mm residual pocket) between the LA and LAA at \>=3 month TEE or CTA evaluation.
| Arm | Type | Description |
|---|---|---|
| AtriClip LAA Exclusion Device | EXPERIMENTAL | AtriClip delivered via minimally invasive surgical procedure |
| Name | Type | Description |
|---|---|---|
| AtriClip LAA Exclusion Device | DEVICE | - |
Inclusion Criteria: 1. Patient is ≥ 18 years and ≤ 80 years of age. 2. Patient has electrocardiographically confirmed non-valvular atrial fibrillation (paroxysmal, persistent, or longstanding persistent AF). 3. CHADS2 or CHA2DS2VASc score ≥2. 4. Patient has medical contraindication to long term ant...