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)
All-cause mortality — 10 years The number of patients that died
Trial sites (14)
Facility
City
Region
Status
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
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.
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