Active safety and performance monitoring of a biodegradable PFO closure device and a transcatheter mitral valve repair system
Official title: Establishment of Active Surveillance and Safety and Efficacy Evaluation Indicators for Innovative Devices Used in Interventional Treatment of Structural Heart Disease
Run by Shanghai Jiao Tong University School of Medicine · NCT07848152 · Data updated 2026-11-12
This study tracks how well a biodegradable PFO closure device and a transcatheter mitral valve repair system work and stay safe when used in routine care.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 2200 (estimated) |
| Sponsor | Shanghai Jiao Tong University School of Medicine Academic / other |
| Locations | 11 sites (Lanzhou, Gansu and 10 other locations) |
| Status | Recruiting |
| Started | December 30, 2025 |
| Main results expected | January 31, 2029 |
| Study ends | January 31, 2029 |
| Registry record updated | September 29, 2026 |
| Trial ID | NCT07848152 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are patients receiving a biodegradable PFO closure device or undergoing transcatheter mitral valve edge-to-edge repair as part of routine clinical care at participating sites.
✕Probably not a fit
Patients who are not receiving either device or who do not have relevant follow-up data may see no direct benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational surveillance program collects clinical data from patients receiving a biodegradable patent foramen ovale closure device and a transcatheter mitral valve edge-to-edge repair system during standard care. The goal is to monitor safety, effectiveness, and long-term outcomes to inform clinical practice and guidance. Data analysis will help develop evaluation indicators and monitoring strategies for these devices. No experimental interventions are assigned by the study; participation is based on routine treatment decisions. The study is conducted across multiple centers in China, led by Shanghai Jiao Tong University School of Medicine.
Why it matters
Potential benefit: Benefits may include improved understanding of device safety and performance in real-world use, informing future patient care and device guidance.
How similar studies have gone: Similar active surveillance efforts have helped characterize device safety and performance in real-world settings, though specifics vary by device and indication.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
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The First Hospital of Lanzhou University
Lanzhou, Gansu, China Recruiting -
Fuwai Central China Cardiovascular Hospital
Zhengzhou, Henan, China Recruiting -
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, China Recruiting -
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China Not yet 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
Show 5 more locations
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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
Study contacts
- Principal investigator: Lijun Fu — Shanghai Children's Medical Center
- Study coordinator: Xinyi Xu
- Email: 3342@scmc.com.cn
- Phone: +86 18930830756
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Edge-to-edge mitral valve repair for ATTR-CM with mitral regurgitation
This trial tests whether adding transcatheter edge-to-edge mitral valve repair helps patients with ATTR-associated cardiomyopathy and significant mitral regurgitation compared with standard medical therapy alone.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.