Active Surveillance and Safety/Efficacy Evaluation of Innovative Devices for Structural Heart Disease Intervention
Condition(s) studied
Study 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.
Eligibility
Primary outcome measure(s)
- Incidence of Major Adverse Events — At 1, 6, and 12 months after the procedure
Incidence of major adverse events related to the biodegradable PFO closure or transcatheter mitral valve edge-to-edge repair procedure during follow-up. - Anatomical success of PFO closure within 12 months after biodegradable PFO occluder implantation, assessed by transthoracic echocardiography — At 1, 6, and 12 months after the procedure
The proportion of participants achieving successful anatomical closure of the patent foramen ovale (PFO) during the 12-month follow-up period after biodegradable PFO occluder implantation, assessed by transthoracic echocardiography. - Incidence of the composite clinical outcome of heart failure hospitalization, all-cause mortality, or cardiovascular mortality within 12 months after transcatheter edge-to-edge mitral valve repair — At 1, 6, and 12 months after the procedure
The proportion of participants experiencing at least one of the following events during the 12-month follow-up period after TEER: hospitalization for heart failure, all-cause death, or cardiovascular death. Events will be assessed through clinical follow-up and review of medical records.
Trial sites (11)
| Facility | City | Region | Status |
|---|---|---|---|
| The First Hospital of Lanzhou University | Lanzhou | Gansu | Recruiting |
| Guangdong Provincial People's Hospital | Guangzhou | Guangdong | Not Yet Recruiting |
| Fuwai Central China Cardiovascular Hospital | Zhengzhou | Henan | Recruiting |
| Zhongnan Hospital of Wuhan University | Wuhan | Hubei | Recruiting |
| General Hospital of Northern Theater Command, Chinese People's Liberation Army | Shenyang | Liaoning | Not Yet Recruiting |
| Shandong Provincial Hospital | Jinan | Shandong | Not Yet Recruiting |
| Sichuan Provincial People's Hospital | Chengdu | Sichuan | Not Yet Recruiting |
| Fuwai Yunnan Hospital, Chinese Academy of Medical Sciences/Affiliated Cardiovascular Hospital of Kunming Medical University | Kunming | Yunnan | 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 |
More Shanghai Jiao Tong University School of Medicine trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07848152 on ClinicalTrials.gov ↗ ← All trials in China