Transcatheter Mitral Valve Edge-to-Edge Repair System

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Condition / disease
Location
Status: Recruiting

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

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.

Participants needed: 2,200
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: Shanghai Jiao Tong University School of MedicineUpdated: Sep 29, 2026Locations: 11Duration: 12 Months
Eligibility criteria

Patients undergoing implantation of a biodegradable PFO closure device. [+1]