Status:
COMPLETED
China XT: Safety and Effectiveness of Edwards Lifesciences SAPIEN XT THV in the Chinese Population
Lead Sponsor:
Edwards Lifesciences
Conditions:
Aortic Stenosis
Symptomatic Aortic Stenosis
Eligibility:
All Genders
60+ years
Phase:
NA
Brief 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 ...
Detailed Description
Edwards SAPIEN XT™ Transcatheter Heart Valve and NovaFlex+ delivery system will be used for this study.
Eligibility Criteria
Inclusion
- 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
- 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+).
Key Trial Info
Start Date :
September 18 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 15 2023
Estimated Enrollment :
67 Patients enrolled
Trial Details
Trial ID
NCT03314857
Start Date
September 18 2017
End Date
June 15 2023
Last Update
September 5 2023
Active Locations (3)
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1
WestChina Hospital, Sichuan University
Sichuan, Chengdu, China
2
Fuwai Hospital, CAMS&PUMC
Beijing, China
3
The Second Affiliated Hospital of Zhejiang University School of
Hangzhou, China