Active Surveillance and Safety/Efficacy Evaluation of Innovative Devices for Structural Heart Disease Intervention
Establishment of Active Surveillance and Safety and Efficacy Evaluation Indicators for Innovative Devices Used in Interventional Treatment of Structural Heart Disease
- Transcatheter Mitral Valve Edge-to-Edge Repair System
- Biodegradable Patent Foramen Ovale Closure Device
At a glance
- Phase
- Phase not stated
- Study type
- Observational
- Sponsor
- Shanghai Jiao Tong University School of Medicine
- Enrolment target
- 2,200
- Started
- 30 December 2025
- Main results due
- 31 January 2029
- Study sites
- 11
- Registry updated
- 29 September 2026
Can you take part?
- Aged 18 years and over.
- Open to any sex.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full eligibility criteria
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.
What this study is about
In the sponsor’s own words, from the registry.
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.
Study sites(11)
The First Hospital of Lanzhou University
Lanzhou, Gansu, China
Recruiting
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China
Not yet recruiting
Fuwai Central China Cardiovascular Hospital
Zhengzhou, Henan, China
Recruiting
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, China
Recruiting
General Hospital of Northern Theater Command, Chinese People's Liberation Army
Shenyang, Liaoning, China
Not yet recruiting
Shandong Provincial Hospital
Jinan, Shandong, China
Not yet recruiting
Sichuan Provincial People's Hospital
Chengdu, Sichuan, China
Not yet recruiting
Fuwai Yunnan Hospital, Chinese Academy of Medical Sciences/Affiliated Cardiovascular Hospital of Kunming Medical University
Kunming, Yunnan, China
Not yet recruiting
Beijing Anzhen Hospital, Capital Medical University
Beijing, China
Not yet recruiting
FUWAI Hospital, CAMS&PUMC
Beijing, China
Not yet recruiting
East Hospital, Tongji University
Shanghai, China
Not yet recruiting
Showing 11 of 11 sites. 3 of the 11 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT07848152. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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