HLT transfemOral Replacement of aortIc Valve Via transcatherteriZatiON

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the safety and performance of the HLT System in patients with severe aortic stenosis who present at High Risk for aortic valve replacement surgery.

Official Title
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HLT transfemOral Replacement of aortIc Valve Via transcatherteriZatiON

Conditions
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Severe Aortic Stenosis, Aortic Valve Stenosis

Intervention / Treatment
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* Device: HLT Transcatheter Aortic Valve System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 75 years of age or older Echocardiographic or hemodynamic based evidence of calcific (senile) aortic stenosis with one of the following: aortic valve EOA <1.0 cm2 or 0.6 cm2/m2 , mean aortic valve gradient >40 mmHg or peak aortic valve velocity >4 m/sec Symptomatology due to aortic stenosis resulting in a New York Heart Association (NYHA) Functional Classification of II or greater Aortic valve annular diameter ≥ 21 and ≤23mm measured by MSCT An STS score ≥10; or Logistic EuroScore I ≥ 15; or a determination by one cardiovascular surgeon and one cardiologist that the co-morbidities not captured by the STS or EuroScore expected to increase the operative mortality risk to > 15%. Geographically available, willing to comply with follow up and able to provide written informed consent Exclusion Criteria: Congenital unicuspid or bicuspid aortic valve, or noncalcified aortic valve; or valve eccentricity (calcific or otherwise) that in the opinion of the investigator could compromise procedural success. Pre-existing prosthetic heart valve in any position, or prosthetic ring Severe (Grade 3 to 4) aortic, mitral or tricuspid valve regurgitation Moderate to severe mitral stenosis Myocardial infarction within the past 30 days* Echocardiographic evidence of intracardiac mass, thrombus or vegetation LVEF < 30% Uncontrolled hypertension (i.e. blood pressure at baseline > 140 mmHg systolic; or in the opinion of the investigator cannot be controlled by medical therapy). Severe pulmonary hypertension with pulmonary systolic pressure greater than two-thirds of systemic pressure Hemodynamic instability requiring inotropic drug therapy within the past 14 days or mechanical support within the past 6 months* Untreated clinically significant coronary artery disease requiring revascularization Presence of significant aortic disease such as atheroma, thrombus, or aneurysm which, in the opinion of the investigator, precludes safe implant delivery Blood dyscrasias defined as: acute leukopenia, acute anemia, acute thrombocytopenia, history of bleeding diathesis or coagulopathy Patient ineligible for or refuses blood transfusions Unfavorable peripheral vascular anatomy or disease (e.g. severe obstructive calcification, severe tortuosity or small vessels) that would preclude passage of catheters from the femoral arterial access to the aorta as evidenced by peripheral MSCT Active peptic ulcer or gastrointestinal bleeding within the past 90 days* Stroke or transient ischemic attack within past 6 months* Renal insufficiency as demonstrated by a serum creatinine > 2.5 mg/dL or end stage renal disease requiring chronic dialysis Active infection requiring ongoing treatment Need for emergent surgery or intervention other than the investigational procedure Any therapeutic invasive cardiac procedure performed or planned to perform within 30 days of the index procedure, (or 6 months for drug eluting coronary stent or biventricular pacemaker implantation)* Hypersensitivity or contraindication to procedural medication and device materials (e.g. titanium, nickel, pork) which cannot be adequately pre-medicated Life expectancy < 1 year due to non-cardiac co-morbid conditions Currently participating in any investigational drug or device studies that may confound the results of this study History of any cognitive or mental health status that would interfere with study participation *At the time of procedure, if a subject's medical status has changed since enrollment, the subject shall be re-evaluated for eligibility.

Ages Eligible for Study
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Minimum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HLT Transcatheter Aortic Valve System<br>Transcatheter aortic valve replacement with an HLT Transcatheter Aortic Valve System | Device: HLT Transcatheter Aortic Valve System<br>* Transcatheter aortic valve replacement with an HLT Transcatheter Aortic Valve System<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Performance Endpoint 1: Procedural Device Performance | The primary performance endpoint is the Device Success defined as: Absence of procedural mortality AND Correct positioning of a single HLT Valve into the proper anatomical location AND Intended performance of the HLT Valve (no prosthesis- patient mismatch and mean aortic valve gradient < 20 mmHg or peak aortic valve velocity < 3 m/sec, AND no moderate or severe aortic valve regurgitation) | Post procedure (day of procedure) | 
| Primary Safety Endpoint 2: Mortality at 30 days | The primary safety endpoint is all-cause mortality at 30 days. | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary Performance Endpoint 1: Post-procedural Valve Performance | The HLT Valve performance will be evaluated by the following parameters with echocardiograms obtained at pre-discharge, 1, 6, 12, 24, 36, 48 and 60 months: Aortic valve effective orifice area (EOA) Severity of aortic valve regurgitation (AR) Aortic valve gradient | pre-discharge (up to 14 days), 1, 6, 12, 24, 36, 48 and 60 months | 
| Secondary Safety Endpoint 2: Adverse Events | All adverse events will be assessed throughout the 5 year follow up period | throughout the 5 year follow up period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Severe aortic stenosis, Aortic valve stenosis, Transcatheter aortic valve replacement