Safety and Effectiveness of Edwards Lifesciences SAPIEN 3 Transcatheter Heart Valve (THV) in the Chinese Population
Safety and Effectiveness of Edwards Lifesciences SAPIEN 3 Transcatheter Heart Valve (THV) in the Chinese Population
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.
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.
Inclusion Criteria:

 1. 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.

 2. 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.

 3. NYHA Functional Class II or greater.

 4. 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.

 5. The study patient agrees to comply with all required postprocedure follow-up visits.

 Exclusion Criteria:

 1. Evidence of an acute myocardial infarction ≤ 1 month (30 days) before the intended
 treatment.

 2. Aortic valve is a congenital unicuspid or is non-calcified.

 3. 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).

 4. Anomalous coronary artery that would interfere with proper placement of the valve.

 5. Mixed aortic valve disease (aortic stenosis and aortic regurgitation with predominant
 aortic regurgitation >3+).