China S3 PMS: SAPIEN 3 China Post Market Registry Study
SAPIEN 3 China Post Market Registry Study
1 other identifier
observational
250
1 country
14
Brief Summary
The objective of this study is to evaluate the long term safety and effectiveness of the SAPIEN 3 Transcatheter Heart Valve system in real world setting.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2022
Longer than P75 for all trials
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 10, 2021
CompletedFirst Posted
Study publicly available on registry
December 23, 2021
CompletedStudy Start
First participant enrolled
January 24, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2035
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2035
July 30, 2025
July 1, 2025
13.9 years
December 10, 2021
July 29, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
All-cause mortality
The number of patients that died
10 years
Study Arms (1)
Transcatheter Aortic Valve Implantation (TAVI)
Interventions
Implantation of the SAPIEN 3 valve
Eligibility Criteria
Subjects who will undergo TAVI with the Edwards SAPIEN 3 System.
You may qualify if:
- Patient with symptomatic, severe, calcified aortic stenosis who is appropriate for the treatment with transcatheter aortic valve replacement as determined by a heart team and will undergo TAVI with the Edwards SAPIEN 3 System as part of standard-of-care treatment
- All surgical risks as determined by the site Heart Team
- The subject or subject's legal representative has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.
You may not qualify if:
- Medical, social, or psychological conditions that preclude appropriate consent and follow-up, including subjects under guardianship
- Considered to be part of a vulnerable population
- Pre-existing mechanical or bioprosthetic aortic valve
- Active SARS-CoV-2 infection or previously diagnosed with COVID-19 with sequelae that could confound endpoint assessments
- Cannot tolerate an anticoagulation/antiplatelet regimen
- Evidence of intracardiac mass, thrombus, vegetation, active infection or endocarditis
- Tortuous or calcified vessels that would prevent safe entry of the dilators and sheath
- Participating in a drug or device study that has not reached its primary endpoint
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (14)
Peking University Third Hospital
Beijing, Beijing Municipality, 100000, China
Xiamen Cardiovascular Hospital Xiamen University
Xiamen, Fujian, 361004, China
First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510000, China
Henan Provincial Chest Hospital
Zhengzhou, Henan, 450000, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450000, China
Union Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, 430022, China
The Second Xiangya Hospital of Central South University
Changsha, Hunan, 410000, China
Shanghai General Hospital
Shanghai, Shangahi, 200000, China
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, 200000, China
Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 200000, China
The First Affiliated Hospital of Xi'an Jiao Tong University
Xi’an, Shanxi, 710000, China
First Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, 830000, China
People's Hospital of Xinjiang Uygur Autonomous Region
Ürümqi, Xinjiang, 830000, China
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 10, 2021
First Posted
December 23, 2021
Study Start
January 24, 2022
Primary Completion (Estimated)
December 1, 2035
Study Completion (Estimated)
December 1, 2035
Last Updated
July 30, 2025
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will not share