China S3: Safety and Effectiveness of Edwards Lifesciences SAPIEN 3 THV in the Chinese Population

Not Applicable

Active, not recruiting

Conditions: Aortic Stenosis
Symptomatic Aortic Stenosis
Aortic Regurgitation

Brief Summary: To evaluate the safety and effectiveness of the SAPIEN 3 (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: Edwards SAPIEN 3 Transcatheter Heart Valve and Commander delivery system will be used for this study.

A maximum of 60 patients with symptomatic severe calcific aortic stenosis requiring transcatheter aortic valve implantation (TAVI), who are considered high risk for surgical valve replacement who received a SAPIEN 3 THV.

Recruitment & Eligibility

Inclusion Criteria

Subjects who are considered to be operable and high risk for surgical valve replacement: STS Score ≥ 8 and ≤ 15 or Logistic EuroSCORE ≥ 15 and ≤ 40. If STS score is below 8 and 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 postprocedure 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+).

Arm && Interventions

Group	Intervention	Description
Patients with SAPIEN 3 THV	SAPIEN 3 THV with the Commander delivery system	Patients will be treated with Edwards SAPIEN 3 Transcatheter Heart Valve and Commander delivery system

Primary Outcome Measures

Name	Time	Method
All-cause Mortality	30-days	All of the deaths that occurred in this population regardless of the cause.

Secondary Outcome Measures

Name	Time	Method
Non-Cardiovascular Mortality	30-days	All of the deaths that occurred in this population due to a non-cardiovascular issue.
Cardiovascular Mortality	30-days	All of the deaths that occurred in this population due to a cardiovascular issue.
Number of Participants With a Stroke	30-days	Total number of participates with a stroke.

Locations (4): The Second Affiliated Hospital of Zhejiang University School of Medicine
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Hangzhou, China
Fuwai Hospital, CAMS&PUMC
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Beijing, China
WestChina Hospital, Sichuan University
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Chengdu, China
Zhongshan Hospital Fudan University
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Shanghai, China