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

Study acronym: ASSEE-SHD
StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study First Submitted
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.
Trial Details
NCT Number NCT07848152
Lead Sponsor Shanghai Jiao Tong University School of Medicine
Collaborators: Chinese Academy of Medical Sciences, Fuwai Hospital, Guangdong Provincial People's Hospital, LanZhou University, Shandong Provincial Hospital, Beijing Anzhen Hospital, Sichuan Provincial People's Hospital, Zhongnan Hospital, Shanghai East Hospital of Tongji University, ScienTech Medical, Valgen Medtech, The General Hospital of Northern Theater Command
Conditions
(from sponsor)		 Transcatheter Mitral Valve Edge-to-Edge Repair System, Biodegradable Patent Foramen Ovale Closure Device
Enrollment 2,200 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov