China XT: Safety and Effectiveness of Edwards Lifesciences SAPIEN XT THV in the Chinese Population

Study Overview
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Brief Summary
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To evaluate the safety and effectiveness of the SAPIEN XT (Edwards Lifesciences, Irvine, California) transcatheter heart valve implantation (TAVI) in Chinese patients with symptomatic severe calcific aortic stenosis who are considered at high risk for surgical valve replacement.

Detailed Description
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Edwards SAPIEN XT™ Transcatheter Heart Valve and NovaFlex+ delivery system will be used for this study.

Official Title
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Safety and Effectiveness of Edwards Lifesciences SAPIEN XT Transcatheter Heart Valve in the Chinese Population

Conditions
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Aortic Stenosis, Symptomatic Aortic Stenosis, Aortic Regurgitation

Intervention / Treatment
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* Device: SAPIEN XT THV with the NovaFlex+ delivery system


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects who are considered to be operable and high risk for surgical valve replacement: 8 ≤ STS Score ≤ 15 or 15 ≤ Logistic EuroSCORE ≤ 40. If STS score is below 8 and/or Logistic EuroSCORE is below 15, patients should have other clinical or anatomical risk factors that would be considered high risk for surgery and documented by the heart team. Severe symptomatic aortic stenosis requiring aortic valve replacement characterized by one or more of the following within 60 days prior to the index procedure: AVA < 0.8 cm2, Indexed AVA <0.5 cm2/m2, mean gradient > 40mmHg, or peak aortic jet velocity > 4.0m/sec. NYHA Functional Class II or greater. The study patient or the study patient's legal representative has been informed of the nature of the study, agrees to its provisions and has provided written informed consent as approved by the EC of the respective clinical site. The study patient agrees to comply with all required post procedure follow-up visits. Exclusion Criteria: Evidence of an acute myocardial infarction ≤ 1 month (30 days) before the intended treatment. Aortic valve is a congenital unicuspid or is non-calcified. Aortic valve is bicuspid and the patient is less than 60 years old, or the aortic valve is bicuspid with no raphe (Sievers classification type 0). Anomalous coronary artery that would interfere with proper placement of the valve. Mixed aortic valve disease (aortic stenosis and aortic regurgitation with predominant aortic regurgitation >3+).

Ages Eligible for Study
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Minimum Age: 60 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: Patients with SAPIEN XT THV<br>Patients will be treated with Edwards SAPIEN XT™ Transcatheter Heart Valve and NovaFlex+ delivery system | Device: SAPIEN XT THV with the NovaFlex+ delivery system<br>* Edwards SAPIEN XT™ Transcatheter Heart Valve along with NovaFlex+ delivery system<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause Mortality | All of the deaths that occurred in this population regardless of the cause. | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiovascular Mortality | All of the deaths that occurred in this population due to a cardiovascular issue. | 30 days | 
| Number of Participates With a Stroke | Total number of participates with a stroke. | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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TAVI, TAVR, CHINA, SAPIEN XT, High Risk, Transcatheter aortic valve implantation, Transcatheter aortic valve replacement