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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03314857
Other study ID # 2015 06
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 18, 2017
Est. completion date June 15, 2023

Study information

Verified date August 2023
Source Edwards Lifesciences
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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


Recruitment information / eligibility

Status Completed
Enrollment 67
Est. completion date June 15, 2023
Est. primary completion date July 6, 2018
Accepts healthy volunteers No
Gender All
Age group 60 Years and older
Eligibility Inclusion Criteria: 1. 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. 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 post procedure 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+).

Study Design


Intervention

Device:
SAPIEN XT THV with the NovaFlex+ delivery system
Edwards SAPIEN XT™ Transcatheter Heart Valve along with NovaFlex+ delivery system

Locations

Country Name City State
China Fuwai Hospital, CAMS&PUMC Beijing
China The Second Affiliated Hospital of Zhejiang University School of Hangzhou
China WestChina Hospital, Sichuan University Sichuan Chengdu

Sponsors (1)

Lead Sponsor Collaborator
Edwards Lifesciences

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary All-cause Mortality All of the deaths that occurred in this population regardless of the cause. 30 days
Secondary Cardiovascular Mortality All of the deaths that occurred in this population due to a cardiovascular issue. 30 days
Secondary Number of Participates With a Stroke Total number of participates with a stroke. 30 days
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