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Active Surveillance and Safety/Efficacy Evaluation of Innovative Devices for Structural Heart Disease Intervention

Recruitingn/aAges 18 Years - anyAllShanghai Jiao Tong University School of Medicine
NCT07848152 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. Patients undergoing implantation of a biodegradable PFO closure device. 2. Patients undergoing transcatheter mitral valve edge-to-edge repair. Exclusion Criteria: The participant expresses a desire to withdraw from the study.
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What it tests

  • Not listed
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Where

11 sites
The First Hospital of Lanzhou University
Lanzhou, China
Guangdong Provincial People's Hospital
Guangzhou, China
Fuwai Central China Cardiovascular Hospital
Zhengzhou, China
Zhongnan Hospital of Wuhan University
Wuhan, China
General Hospital of Northern Theater Command, Chinese People's Liberation Army
Shenyang, China
Shandong Provincial Hospital
Jinan, China
Sichuan Provincial People's Hospital
Chengdu, China
Fuwai Yunnan Hospital, Chinese Academy of Medical Sciences/Affiliated Cardiovascular Hospital of Kunming Medical University
Kunming, China

…and 3 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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