REPRISE II: Repositionable Percutaneous Replacement of Stenotic Aortic Valve through Implantation of Lotus Valve System - Evaluation of Safety and Perfomance

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 20

Inclusion Criteria

IC1. Subject is >=70 years of age
IC2. Subject has documented calcific native aortic valve stenosis with an initial aortic valve area (AVA) of <1.0 cm2 (or AVA index of <0.6 cm2/m2) and either a mean pressure gradient >40 mm Hg or a jet velocity >4 m/s, as measured by echocardiography
IC3. Subject has a documented aortic annulus size between >=20 and <=27 mm based on pre-procedure diagnostic imaging
IC4. Symptomatic aortic valve stenosis with NYHA Functional Class >= II
IC5. Subject is considered high risk for surgical valve replacement based on at least one of the following:
a. Society of Thoracic Surgeons (STS) score >=8%, AND/OR
b. Agreement by the heart team (which must include an in-person evaluation by an experienced cardiac surgeon) that subject is at high operative risk of serious morbidity or mortality with surgical valve replacement
IC6. Heart team (which must include an experienced cardiac surgeon) assessment that the subject is likely to benefit from valve replacement.
IC7. Subject (or legal representative) understands the study requirements and the treatment procedures, and provides written informed consent.
IC8. Subject, family member, and/or legal representative agree(s) and subject is capable of returning to the study hospital for all required scheduled follow up visits.

Exclusion Criteria

EC1. Subject has a congenital unicuspid or bicuspid aortic valve.
EC2. Subject with an acute myocardial infarction within 30 days of 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, or has any permanent neurologic defect prior to study enrollment.
EC4. Subject is on dialysis or has serum creatinine level >3.0 mg/dL or 265 µmol/L.
EC5. Subject has a pre-existing prosthetic heart valve (aortic or mitral) or a prosthetic ring in any position.
EC6. Subject has >=3+ mitral regurgitation, >=3+ aortic regurgitation or >=3+ tricuspid regurgitation (i.e., subject cannot have more than moderate mitral, aortic or tricuspid regurgitation).
EC7. Subject has a need for emergency surgery for any reason.
EC8. Subject has a history of endocarditis within 12 months of index procedure or evidence of an active systemic infection or sepsis.
EC9. Subject has echocardiographic evidence of intra-cardiac mass, thrombus or vegetation.
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.
EC24. Subject has untreated conduction system disorder (e.g., Type II second degree atrioventricular block) that in the opinion of the treating physician is clinically significant and requires a pacemaker implantation.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>- Primary Device Performance Endpoint: mean aortic valve pressure gradient at<br /><br>30 days post implant procedure as measured by echocardiography and assessed by<br /><br>an independent core laboratory<br /><br>- Primary Safety Endpoint: all-cause mortality at 30 days post implant<br /><br>procedure</p><br>

Secondary Outcome Measures