Safety and Performance Study of the Edwards CENTERA 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 patients with symptomatic, severe aortic stenosis who are indicated for aortic valve replacement.

Detailed Description
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This is a non-randomized, prospective, multi-center safety and device success study. 34 patients have been enrolled at 4 participating investigational centers in Europe. 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 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: High surgical risk: STS Score ≥ 8,EuroSCORE ≥ 15. NYHA ≥ II. Heart team (including examining cardiac surgeon) agrees on eligibility including assessment that TAVR is appropriate. 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: 19 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: TAVR<br>with CENTERA self-expanding valve | 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 | NAP | 30 days post-index procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| device success | Device success is defined as a composite of the following events: Factor 1: Absence of procedural mortality Factor 2: Correct positioning of a single prosthetic valve into the proper anatomical location Factor 3: Intended performance of the prosthetic heart valve (per the 30-day core lab echo assessment). It is measured in % (favorable measures/total measures). | 30 days | 
| device success | Device success is defined as a composite of the following events: Factor 1: Absence of procedural mortality Factor 2: Correct positioning of a single prosthetic valve into the proper anatomical location Factor 3: Intended performance of the prosthetic heart valve (per the 30-day core lab echo assessment). It is measured in % (favorable measures/total measures). | 1 year | 

 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