The SAPIEN 3 Ultra System in Intermediate Risk Patients With Symptomatic, Severe Aortic Stenosis

Study Overview
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Brief Summary
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This study will confirm the procedural safety and performance of the SAPIEN 3 Ultra System in subjects with severe, calcific AS who are at intermediate operative risk for standard aortic valve replacement.

Official Title
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A Prospective, Single-arm, Multicenter Study of the SAPIEN 3 Ultra System in Intermediate Risk Patients With Severe, Calcific, Aortic Stenosis Requiring Aortic Valve Replacement

Conditions
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Aortic Valve Stenosis

Intervention / Treatment
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* Device: SAPIEN 3 Ultra Delivery System with the SAPIEN 3 Ultra THV


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Severe, calcific aortic stenosis meeting the following transthoracic echocardiogram criteria: Aortic valve area ≤ 1.0 cm2 OR aortic valve area index ≤ 0.6 cm2/m2 Jet velocity ≥ 4.0 m/s OR mean gradient ≥ 40 mmHg New York Heart Association functional class ≥ II Judged by the Heart Team to be at intermediate risk for open surgical therapy The subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent. Exclusion Criteria: Native aortic annulus size unsuitable for available THV sizes on 3D imaging analysis Aortic valve is unicuspid, bicuspid or non-calcified Pre-existing mechanical or bioprosthetic valve in any position. Severe aortic regurgitation (> 3+) Severe mitral regurgitation (> 3+) or ≥ moderate stenosis Ventricular dysfunction with left ventricular ejection fraction < 30% Cardiac imaging evidence of intracardiac mass, thrombus or vegetation Evidence of an acute myocardial infarction ≤ 30 days before the valve implant procedure Subjects with planned concomitant ablation for atrial fibrillation Hypertrophic cardiomyopathy with obstruction Coronary anatomy that increases the risk of coronary artery obstruction post-TAVR Complex coronary artery disease: Unprotected left main coronary artery SYNTAX score > 32 Heart Team assessment that optimal revascularization cannot be performed Iliofemoral vessel characteristics that would preclude safe placement of the introducer sheath Significant abdominal or thoracic aortic disease that would preclude safe passage of the delivery system Active bacterial endocarditis within 180 days of the valve implant procedure Stroke or transient ischemic attack within 90 days of the valve implant procedure Symptomatic carotid or vertebral artery disease or successful treatment of carotid stenosis within 30 days of the valve implant procedure Severe lung disease (Forced Ejection Volume 1 < 50% predicted) or currently on home oxygen Severe pulmonary hypertension Hemodynamic or respiratory instability requiring inotropic support, mechanical ventilation or mechanical heart assistance within 30 days of the valve implant procedure History of cirrhosis or any active liver disease Renal insufficiency and/or renal replacement therapy at the time of screening Leukopenia, anemia, thrombocytopenia, history of bleeding diathesis or coagulopathy or hypercoagulable states Inability to tolerate or condition precluding treatment with antithrombotic therapy during or after the valve implant procedure Absolute contraindications or allergy to iodinated contrast that cannot be adequately treated with pre-medication Significant frailty as determined by the Heart Team Subject refuses blood products Body mass index > 50 kg/m2 Estimated life expectancy < 24 months Positive urine or serum pregnancy test in female subjects of childbearing potential Currently participating in an investigational drug or another device study.
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
Interventional Model Description: SAPIEN 3 Ultra System
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Transcatheter Aortic Valve Replacement (TAVR)<br> | Device: SAPIEN 3 Ultra Delivery System with the SAPIEN 3 Ultra THV<br>* Patients will be implanted with the SAPIEN 3 Ultra THV (20, 23 and 26 mm) or SAPIEN 3 THV (29 mm) using the SAPIEN 3 Ultra Delivery System.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedural Success | The number of patients with procedural success, defined as freedom from all of the following at exit from the procedure room: Mortality Conversion to surgery Moderate or severe paravalvular regurgitation | Day 0 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major Vascular Complications | Number of patients with major vascular complications | Discharge, expected to be within 1-5 days post-procedure] | 
| Valve Migration or Embolization | Number of patients with valve migration or embolization | Discharge, expected to be within 1-5 days post-procedure] | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SAPIEN 3 Ultra, Transcatheter, Transcatheter Valve Replacement