Stroke Feasibility Study
|Atrial Fibrillation AFib||Device: AtriClip LAA Exclusion Device||Phase 1 Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Feasibility Clinical Investigation of a Minimally Invasive Surgically Deployed AtriCure AtriClip Left Atrial Appendage Exclusion System for Stroke Prophylaxis in Patients With Non-Valvular Atrial Fibrillation and in Whom Long Term Oral Anticoagulation Therapy is Medically Contraindicated|
- Number of Serious Adverse Events Within 30 Days Post-Index Procedure [ Time Frame: 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).
- Composite Left Atrial Appendage Placement and Exclusion Success [ Time Frame: Immediate to 3-months post-index procedure ]
Primary Efficacy endpoint is a success/failure endpoint with success requiring all of the following:
- Patient Technical Success: The ability to successfully implant an AtriClip device at the LAA in a patient.
- 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 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.
- Rate of Stroke and Non-CNS Systemic Embolism [ Time Frame: 3 months and 6 months post-index procedure ]
The secondary efficacy endpoints will be a composite of the following events within 3 months and 6 months post-index procedure:
- Stroke (ischemic )
- Non-CNS (Central Nervous System) systemic embolism.
- Serious Device or Procedure Related Adverse Event Rate [ Time Frame: 3 month and 6 month post-index procedure ]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.
- Overall Serious Adverse Event Rate [ Time Frame: 3 month and 6 month Post Index Procedure ]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.
- Overall Adverse Event Rate [ Time Frame: 3 month and 6 month post-index procedure ]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.
|Study Start Date:||January 2014|
|Study Completion Date:||August 2015|
|Primary Completion Date:||July 2015 (Final data collection date for primary outcome measure)|
Experimental: AtriClip LAA Exclusion Device
AtriClip delivered via minimally invasive surgical procedure
Device: AtriClip LAA Exclusion Device
Please refer to this study by its ClinicalTrials.gov identifier: NCT01997905
|United States, California|
|St. Helena Hospital|
|St. Helena, California, United States, 94574|
|United States, Florida|
|Miami, Florida, United States, 33133|
|United States, Indiana|
|Franciscan St. Francis Health|
|Indianapolis, Indiana, United States, 46237|
|United States, Ohio|
|Good Samaritan Hospital|
|Cincinnati, Ohio, United States, 45220|
|United States, Texas|
|Houston Methodist Hospital|
|Houston, Texas, United States, 77030|
|United States, Virginia|
|University of Virginia|
|Charlottesville, Virginia, United States, 22908|
|United States, Wisconsin|
|Wausau, Wisconsin, United States, 54401|
|Principal Investigator:||Basel Ramlawi, MD||Methodist Hospital Houston|