NL-OMON44639
Completed
Phase 3
REPRISE III: REpositionable Percutaneous Replacement of Stenotic Aortic Valve through Implantation of Lotus* Valve System - Randomized Clinical Evaluation - REPRISE III
Boston Scientific Cooperation International0 sites20 target enrollmentTBD
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Boston Scientific Cooperation International
- Enrollment
- 20
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •IC1\. Subject has documented calcific, severe native aortic stenosis with an initial AVA of \<\=1\.0 cm2 (or AVA index of \<\=0\.6 cm2/m2\) and a mean pressure gradient \>\=40 mm Hg or jet velocity \>\=4\.0 m/s, as measured by echocardiography and/or invasive hemodynamics.
- •IC2\. Subject has a documented aortic annulus size of \>\=20 mm and \<\=27 mm based on the center\*s assessment of pre\-procedure diagnostic imaging (and confirmed by the Case Review Committee \[CRC]) and is deemed treatable with an available size of both test and control device.
- •IC3\. Subject has symptomatic aortic valve stenosis with NYHA Functional Class \>\= II.
- •IC4\. There is agreement by the heart team (which must include a site investigator interventionalist and a site investigator cardiac surgeon) that subject is at high or extreme operative risk for surgical valve replacement (see note below for definitions of extreme and high risk, the required level of surgical assessment, and CRC confirmation) and that TAVR is appropriate. Additionally, subject has at least one of the following.
- •Society of Thoracic Surgeons (STS) score \>\=8% \-OR\-
- •If STS \<8, subject has at least one of the following conditions:
- •o Hostile chest
- •o Porcelain aorta
- •o Severe pulmonary hypertension (\>60 mmHg)
- •o Prior chest radiation therapy
Exclusion Criteria
- •EC1\. Subject has a congenital unicuspid or bicuspid aortic valve.
- •EC2\. Subject has had an acute myocardial infarction within 30 days prior to the index procedure (defined as Q\-wave MI or non\-Q\-wave MI with total CK elevation \>\= twice normal in the presence of CK\-MB elevation and/or troponin elevation).
- •EC3\. Subject has had a cerebrovascular accident or transient ischemic attack within the past 6 months prior to study enrollment.
- •EC4\. Subject has end\-stage renal disease or has GFR \<20 (based on Cockcroft\-Gault formula).
- •EC5\. Subject has a pre\-existing prosthetic aortic or mitral valve.
- •EC6\. Subject has severe (4\+) aortic, tricuspid, or mitral regurgitation.
- •EC7\. Subject has a need for emergency surgery for any reason.
- •EC8\. Subject has a history of endocarditis within 6 months of index procedure or evidence of an active systemic infection or sepsis.
- •EC9\. Subject has echocardiographic evidence of new intra\-cardiac vegetation or intraventricular or paravalvular thrombus requiring intervention..
- •EC10\. Subject has Hgb \<9 g/dL, platelet count \<50,000 cells/mm3 or \>700,000 cells/mm3, or white blood cell count \<1,000 cells/mm3\.
Outcomes
Primary Outcomes
Not specified
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