Brief Title
China S3: Safety and Effectiveness of Edwards Lifesciences SAPIEN 3 THV in the Chinese Population
Official Title
Safety and Effectiveness of Edwards Lifesciences SAPIEN 3 Transcatheter Heart Valve (THV) in the Chinese Population
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.
Study Type
Interventional
Primary Outcome
All-cause Mortality
Secondary Outcome
Cardiovascular Mortality
Condition
Aortic Stenosis
Intervention
SAPIEN 3 THV with the Commander delivery system
Study Arms / Comparison Groups
Patients with SAPIEN 3 THV
Description: Patients will be treated with Edwards SAPIEN 3 Transcatheter Heart Valve and Commander delivery system
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
58
Start Date
May 23, 2018
Completion Date
September 2023
Primary Completion Date
July 3, 2019
Eligibility Criteria
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+).
Gender
All
Ages
19 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Prof Junbo GE, ,
Location Countries
China
Location Countries
China
Administrative Informations
NCT ID
NCT03466918
Organization ID
2017-08
Responsible Party
Sponsor
Study Sponsor
Edwards Lifesciences
Study Sponsor
Prof Junbo GE, Principal Investigator, Zhongshan Hospital and Fudan University
Verification Date
August 2021