Stroke Feasibility Study
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01997905|
Recruitment Status : Completed
First Posted : November 28, 2013
Results First Posted : October 21, 2016
Last Update Posted : December 14, 2016
|Condition or disease||Intervention/treatment||Phase|
|Atrial Fibrillation AFib||Device: AtriClip LAA Exclusion Device||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||13 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||January 2014|
|Actual Primary Completion Date :||July 2015|
|Actual Study Completion Date :||August 2015|
Experimental: AtriClip LAA Exclusion Device
AtriClip delivered via minimally invasive surgical procedure
Device: AtriClip LAA Exclusion Device
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|