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.
Patients undergoing implantation of a biodegradable PFO closure device.
Patients undergoing transcatheter mitral valve edge-to-edge repair.
None
1. Biodegradable PFO Closure Device Cohort: Patients with confirmed PFO-associated ischemic stroke who undergo implantation of a biodegradable PFO closure device. 2. Transcatheter Mitral Valve Edge-to-Edge Repair (TEER) Cohort: Patients with functional or degenerative mitral regurgitation who undergo transcatheter mitral valve edge-to-edge repair using a TEER system.
Cohort
Prospective
Not listed
Incidence of Major Adverse Events
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
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
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.
Degree of device degradation
The degree of degradation of the biodegradable PFO closure device will be assessed by echocardiography during follow-up.
Incidence of residual shunt after PFO closure
The presence of residual shunt after implantation of the biodegradable PFO closure device will be assessed by echocardiography with contrast study, when applicable.
Incidence of re-intervention after PFO closure
The percentage of participants requiring reapeat intervention or surgical treatment related to the PFO closure device during follow-up.
Incidence of recurrent stroke after PFO closure
The occurrence of recurrent ischemic or hemorrhagic stroke during the follow-up period will be assessed by clinical evaluation and review of medical records.
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Shanghai Jiao Tong University School of Medicine
Lead sponsor
Chinese Academy of Medical Sciences, Fuwai Hospital
Collaborator
Guangdong Provincial People's Hospital
Collaborator
LanZhou University
Collaborator
Shandong Provincial Hospital
Collaborator
Beijing Anzhen Hospital
Collaborator
Sichuan Provincial People's Hospital
Collaborator
Zhongnan Hospital
Collaborator
Shanghai East Hospital of Tongji University
Collaborator
ScienTech Medical
Collaborator
Valgen Medtech
Collaborator
The General Hospital of Northern Theater Command
Collaborator
