Status:
COMPLETED
China S3: Safety and Effectiveness of Edwards Lifesciences SAPIEN 3 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 3 (Edwards Lifesciences, Irvine, California) transcatheter heart valve implantation (TAVI) in Chinese patients with symptomatic severe calcific a...
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...
Eligibility Criteria
Inclusion
- 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
- 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 :
May 23 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 19 2024
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT03466918
Start Date
May 23 2018
End Date
June 19 2024
Last Update
September 10 2025
Active Locations (4)
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1
Fuwai Hospital, CAMS&PUMC
Beijing, China
2
WestChina Hospital, Sichuan University
Chengdu, China
3
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, China
4
Zhongshan Hospital Fudan University
Shanghai, China