🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Clinical Trials in China / NCT05168826
Active, not recruiting Observational

China S3 PMS: SAPIEN 3 China Post Market Registry Study

NCT05168826 · tracked via the Priya Life Science China tracker
Sponsor
Edwards Lifesciences
Phase
Observational
Started
2022-01-24
Last updated
2026-08-12

Condition(s) studied

Aortic Stenosis, Severe

Investigational drug(s) / intervention(s)

SAPIEN 3 Transcatheter Heart Valve

SAPIEN 3 Transcatheter Heart Valve: Implantation of the SAPIEN 3 valve

Study 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.

Eligibility

Sex
ALL
Min age
Max age
Healthy volunteers
No
Inclusion Criteria: 1. 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 2. All surgical risks as determined by the site Heart Team 3. 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. Exclusion Criteria: 1. Medical, social, or psychological conditions that preclude appropriate consent and follow-up, including subjects under guardianship 2. Considered to be part of a vulnerable population 3. Pre-existing mechanical or bioprosthetic aortic valve 4. Active SARS-CoV-2 infection or previously diagnosed with COVID-19 with sequelae that could confound endpoint assessments 5. Cannot tolerate an anticoagulation/antiplatelet regimen 6. Evidence of intracardiac mass, thrombus, vegetation, active infection or endocarditis 7. Tortuous or calcified vessels that would prevent safe entry of the dilators and sheath 8. Participating in a drug or device study that has not reached its primary endpoint

Primary outcome measure(s)

Trial sites (14)

FacilityCityRegionStatus
Peking University Third Hospital Beijing Beijing Municipality
Xiamen Cardiovascular Hospital Xiamen University Xiamen Fujian
First Affiliated Hospital of Sun Yat-sen University Guangzhou Guangdong
Henan Provincial Chest Hospital Zhengzhou Henan
The First Affiliated Hospital of Zhengzhou University Zhengzhou Henan
Union Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology Wuhan Hubei
The Second Xiangya Hospital of Central South University Changsha Hunan
Shanghai General Hospital Shanghai Shangahi
Shanghai Chest Hospital Shanghai Shanghai Municipality
Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine Shanghai Shanghai Municipality
The First Affiliated Hospital of Xi'an Jiao Tong University Xi’an Shanxi
First Affiliated Hospital of Xinjiang Medical University Ürümqi Xinjiang
People's Hospital of Xinjiang Uygur Autonomous Region Ürümqi Xinjiang
The Second Affiliated Hospital Zhejiang University School of Medicine Hangzhou Zhejiang

More Edwards Lifesciences trials in China

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05168826 on ClinicalTrials.gov ↗ ← All trials in China