This is a feasibility study to assess the safety and efficacy of the AtriCure AtriClip when placed via Minimally Invasive Surgical Deployment to the Left Atrial Appendage. The purpose is for evaluation of Stroke Prevention in Patients with Non-Valvular Atrial Fibrillation who are unable to take Oral Anticoagulants.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
13
St. Helena Hospital
St. Helena, California, United States
Mercy Hospital
Miami, Florida, United States
Franciscan St. Francis Health
Indianapolis, Indiana, United States
Good Samaritan Hospital
Cincinnati, Ohio, United States
Number of Serious Adverse Events Within 30 Days Post-Index Procedure
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).
Time frame: 30 days post-index procedure
Composite Left Atrial Appendage Placement and Exclusion Success
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.
Time frame: Immediate to 3-months post-index procedure
Rate of Stroke and Non-CNS Systemic Embolism
The secondary efficacy endpoints will be a composite of the following events within 3 months and 6 months post-index procedure: 1. Stroke (ischemic ) 2. Non-CNS (Central Nervous System) systemic embolism.
Time frame: 3 months and 6 months post-index procedure
Serious Device or Procedure Related Adverse Event Rate
Overall Serious Device or Procedure Related Adverse Event Rate: Incidence of all serious device or procedure related adverse events observed through the 3 month and 6 month follow-up assessments as adjudicated by Independent Physician Adjudicator.
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Houston Methodist Hospital
Houston, Texas, United States
University of Virginia
Charlottesville, Virginia, United States
Aspirus
Wausau, Wisconsin, United States
Time frame: 3 month and 6 month post-index procedure
Overall Serious Adverse Event Rate
Overall Serious Adverse Event Rate: Incidence of all serious adverse events, regardless of attribution, observed through the 3 month and 6 month follow-up assessments, as adjudicated by Independent Physician Adjudicator.
Time frame: 3 month and 6 month Post Index Procedure
Overall Adverse Event Rate
Overall Adverse Event Rate: Incidence of all device and procedure related adverse events and any neurological related AEs, regardless of attribution, observed through the 3 month and 6 month follow-up assessments, as adjudicated by Independent Physician Adjudicator.
Time frame: 3 month and 6 month post-index procedure