Stroke Feasibility Study
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.
Device: AtriClip LAA Exclusion Device
|Study Design:||Endpoint Classification: Safety/Efficacy Study
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|
- Serious Adverse Events within 30 Days Post-Index Procedure [ Time Frame: 30 days post-index procedure ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: Yes ]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|
|Estimated Study Completion Date:||February 2018|
|Estimated 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
|Contact: Shana Zinkfirstname.lastname@example.org|
|United States, Florida|
|Miami, Florida, United States, 33133|
|Contact: Saqib Masroor|
|Contact: John Morgan 305-285-2792 John.Morgan@hcahealthcare.com|
|United States, Indiana|
|Franciscan St. Francis Health||Recruiting|
|Indianapolis, Indiana, United States, 46237|
|Contact: Marc Gerdisch|
|Contact: Molly Miller 317-893-1948 Molly.Miller@franciscanalliance.org|
|United States, Ohio|
|Good Samaritan Hospital||Recruiting|
|Cincinnati, Ohio, United States, 45220|
|Contact: J. Michael Smith|
|Contact: Carol Krabbe 513-862-2877 email@example.com|
|United States, Texas|
|Houston Methodist Hospital||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Basel Ramlawi|
|Contact: Jonathan Wiese 713-441-7161 firstname.lastname@example.org|
|United States, Virginia|
|University of Virginia||Recruiting|
|Charlottesville, Virginia, United States, 22908|
|Contact: Gorav Ailawadi|
|Contact: J. Michael Cosner 434-982-6003 PIC #3523 JMC2CM@hscmail.mcc.virginia.edu|
|United States, Wisconsin|
|Wausau, Wisconsin, United States, 54401|
|Contact: John Johnkoski|
|Contact: Megan Johnson 715-847-2000, ext. 50160 Megan.Johnson@aspirus.org|
|Principal Investigator:||Basel Ramlawi, MD||Methodist Hospital Houston|