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Active Surveillance and Safety/Efficacy Evaluation of Innovative Devices for Structural Heart Disease Intervention
Sponsor: Shanghai Jiao Tong University School of Medicine
Summary
This study aims to establish an active surveillance system to evaluate the safety and effectiveness of innovative medical devices used in the interventional treatment of structural heart disease. The devices of interest include a biodegradable patent foramen ovale (PFO) closure device and a transcatheter mitral valve edge-to-edge repair system. Clinical information from patients receiving these devices during routine clinical care will be collected and analyzed. The findings will help evaluate the safety and effectiveness of these devices and support the development of appropriate clinical evaluation indicators and long-term monitoring strategies.
Official title: Establishment of Active Surveillance and Safety and Efficacy Evaluation Indicators for Innovative Devices Used in Interventional Treatment of Structural Heart Disease
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
2200
Start Date
2025-12-30
Completion Date
2029-01-31
Last Updated
2026-09-29
Healthy Volunteers
No
Conditions
Locations (11)
The First Hospital of Lanzhou University
Lanzhou, Gansu, China
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China
Fuwai Central China Cardiovascular Hospital
Zhengzhou, Henan, China
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, China
General Hospital of Northern Theater Command, Chinese People's Liberation Army
Shenyang, Liaoning, China
Shandong Provincial Hospital
Jinan, Shandong, China
Sichuan Provincial People's Hospital
Chengdu, Sichuan, China
Fuwai Yunnan Hospital, Chinese Academy of Medical Sciences/Affiliated Cardiovascular Hospital of Kunming Medical University
Kunming, Yunnan, China
Beijing Anzhen Hospital, Capital Medical University
Beijing, China
FUWAI Hospital, CAMS&PUMC
Beijing, China
East Hospital, Tongji University
Shanghai, China