CENTERA-2: Safety and Performance Study of the Edwards CENTERA-EU Self-Expanding Transcatheter Heart Valve

Study Overview
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Brief Summary
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The purpose of this study is to assess the safety and device success of the Edwards CENTERA Transcatheter Heart Valve (THV) System in symptomatic adult patients with severe aortic stenosis.

Detailed Description
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This is a non-randomized, prospective, multi-center safety and device success study. Up to two hundred (200) patients are planned to be implanted at up to 35 participating investigational centers in Europe, Australia and New Zealand. Patient participation will last for a minimum of 5 years. Patients will be assessed at the following intervals: baseline, discharge, 30 days, 6 months, 1 year and annually thereafter through 5 years.

Official Title
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Safety and Performance Study of the Edwards CENTERA-EU Self-Expanding Transcatheter Heart Valve

Conditions
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Aortic Valve Disease

Intervention / Treatment
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* Device: Edwards CENTERA Self-Expanding Transcatheter Heart Valve


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Heart team (including cardiac surgeon) agrees on eligibility including as-sessment that TAVI is appropriate. High surgical risk: 8 ≤ STS Score ≤ 15 or 15 ≤ Logistic EuroSCORE I ≤ 40. NYHA ≥ II. Study patient is an adult of legal consent age. Study patient has provided written informed consent to comply with all of the study procedures and follow-up visits. Exclusion Criteria: Acute myocardial infarction ≤ 30 days before the intended treatment. Untreated clinically significant coronary artery disease requiring revascularization. Aortic valve is a congenital unicuspid or congenital bicuspid valve. Mixed aortic valve disease (with predominant aortic regurgitation).

Ages Eligible for Study
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Minimum Age: 18 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: single-arm<br> | Device: Edwards CENTERA Self-Expanding Transcatheter Heart Valve<br>* The Edwards CENTERA Transcatheter Heart Valve (THV) System is indicated for use in symptomatic patients (high surgical risk) with severe aortic stenosis requiring aortic valve replacement (AVR).<br>* Other names: TAVI;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause mortality rate |  | 30 days post-index procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety composite of mortality, stroke, major vascular, complication, life-threatening bleeding, acute kidney injury coronary artery obstruction requiring intervention, and THV-related dysfunction requiring repeat procedure. |  | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Transcatheter Aortic Valve Replacement, Aortic Stenosis