ExCEED: CENTERA THV System in Intermediate Risk Patients Who Have Symptomatic, Severe, Calcific, Aortic Stenosis

Study Overview
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Brief Summary
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This study will monitor the safety and valve performance of the Edwards CENTERA Transcatheter Heart Valve (THV) System in patients with symptomatic, severe, calcific aortic stenosis who are at intermediate operative risk for surgical aortic valve replacement (SAVR).

Detailed Description
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A prospective, single-arm, controlled, multicenter study. Up to 2 roll-ins were allowed per site but not counted towards total enrollment.

Official Title
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A Prospective, Single-arm, Controlled, Multicenter Study to Establish the Safety and Effectiveness of the CENTERA THV System in Intermediate Risk Patients Who Have Symptomatic, Severe, Calcific, Aortic Stenosis Requiring Aortic Valve Replacement

Conditions
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Aortic Valve Stenosis

Intervention / Treatment
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* Device: TAVR with CENTERA THV


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Severe, calcific AS NYHA 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 sizes 23, 26 or 29 mm CENTERA THV based on 3D imaging analysis Aortic valve is unicuspid, bicuspid or non-calcified Pre-existing mechanical or bioprosthetic valve in any position Known hypersensitivity to Nitinol (nickel or titanium) 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 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 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 Immobility that would prevent completion of study procedures 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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Transcatheter Aortic Valve Replacement (TAVR)<br> | Device: TAVR with CENTERA THV<br>* TAVR with the Edwards CENTERA THV System<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause Death | Number of participants that died | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Transcatheter Heart Valve, CENTERA, self-expanding, THV