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AtriClip LAA Exclusion Device · 1 trial · 2 indications
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...
The AtriClip LAA Exclusion Device is used for atrial fibrillation (AFib). It is a device designed to exclude the left atrial appendage (LAA), which is a common source of blood clots in patients with AFib. The device is currently in clinical development and is being studied for its potential role in stroke prevention.
AtriClip LAA Exclusion Device is developed by AtriCure, Inc., a company traded on the stock exchange under the ticker symbol ATRC. AtriCure specializes in medical devices for the treatment of atrial fibrillation and other cardiac conditions.
AtriClip LAA Exclusion Device is in Phase 1 of clinical development. It is an investigational device and has not yet been approved by regulatory authorities. The device is being studied in early-stage clinical trials to assess its safety and feasibility.
AtriClip LAA Exclusion Device has one completed clinical trial, identified by the National Clinical Trial number NCT01997905, titled 'Stroke Feasibility Study'. This Phase 1 trial enrolled 13 participants with atrial fibrillation in the United States. The trial was not randomized, double-blind, or controlled.
AtriClip LAA Exclusion Device is not FDA approved. It is an investigational device currently in Phase 1 clinical development. The device has completed a feasibility study, but it has not yet received regulatory approval for commercial use in the treatment of atrial fibrillation.