China S3 PMS: SAPIEN 3 China Post Market Registry Study

Recruiting

• Conditions: Aortic Stenosis, Severe
• Interventions: Device: SAPIEN 3 Transcatheter Heart Valve

• Registration Number: NCT05168826
• Lead Sponsor: Edwards Lifesciences

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.

Detailed Description

This is an observational, single-arm, multicentre, post-market study.

Study Timeline

• Study First Submitted: 2021-12-10
• Study First Submitted QC: 2021-12-10
• Study First Posted: 2021-12-23
• Study Start: 2022-01-24
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-15
• Last Update Posted: 2024-10-17
• Primary Completion: 2035-12
• Study Completion: 2035-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 250

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Transcatheter Aortic Valve Implantation (TAVI)	SAPIEN 3 Transcatheter Heart Valve	-

Primary Outcome Measures

Name	Time	Method
All-cause mortality	10 years	The number of patients that died

Trial Locations

Locations (14)

Shanghai Chest Hospital; 🇨🇳 Shanghai, Shanghai, China

The Second Affiliated Hospital Zhejiang University School of Medicine; 🇨🇳 Hangzhou, Zhejiang, China

Xiamen Cardiovascular Hospital Xiamen University; 🇨🇳 Xiamen, Fujian, China

First Affiliated Hospital of Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China

Henan Provincial Chest Hospital; 🇨🇳 Zhengzhou, Henan, China

Peking University Third Hospital; 🇨🇳 Beijing, Beijing, China

The First Affiliated Hospital of Zhengzhou University; 🇨🇳 Zhengzhou, Henan, China

Union Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology; 🇨🇳 Wuhan, Hubei, China

The Second Xiangya Hospital of Central South University; 🇨🇳 Changsha, Hunan, China

Shanghai General Hospital; 🇨🇳 Shanghai, Shangahi, China

Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine; 🇨🇳 Shanghai, Shanghai, China

The First Affiliated Hospital of Xi'an Jiao Tong University; 🇨🇳 Xi'an, Shanxi, China

First Affiliated Hospital of Xinjiang Medical University; 🇨🇳 Ürümqi, Xinjiang Province, China

People's Hospital of Xinjiang Uygur Autonomous Region; 🇨🇳 Ürümqi, Xinjiang Province, China