Regent China Post-Market Clinical Follow-Up (RC-PMCF): this clinical study is to confirm the safety and performance of Abbott's Regent MHV for replacement of native or prosthetic aortic valves in a Chinese population.
The purpose of the RC-PMCF study is to meet the post-market clinical followup (PMCF) requirements of the National Medical Products Administration (NMPA). The primary objective of this clinical study is to confirm the safety and performance of Abbott's Regent MHV for replacement of native or prosthetic aortic valves in a Chinese population. This is a prospective, observational, multi-center study of subjects clinically indicated for implantation of an Abbott Medical's Regent Valve.
Study Type
OBSERVATIONAL
Enrollment
200
SJM Regent™- Standard cuff (Model number AGN-751); SJM Regent™- FlexCuff™ (Model number AGFN-756)
The People's Hospital of Gaozhou
Gaozhou, China
The Second Affiliated Hospital of Nanchang University
Nanchang, China
Ningbo Medical Center Lihuili Hospital
Ningbo, China
Wuhan Union Hospital of China
Wuhan, China
Primary Safety Endpoint: The Freedom From Valve-related Mortality
Valve-related mortality is any death caused by structural valve deterioration, nonstructural dysfunction, valve thrombosis, embolism, bleeding event, or operated valve endocarditis; death related to reintervention on the operated valve; or sudden, unexplained death. Deaths caused by heart failure in patients with advanced myocardial disease and satisfactorily functioning cardiac valves are not counted. Specific causes of valve-related deaths should be reported.
Time frame: At one year
Primary Performance Endpoint: The Freedom From Valve-related Reoperation
Valve-related reoperation includes any reintervention that is a surgical or percutaneous interventional catheter procedure that repairs, otherwise alters or adjusts, or replaces the previously implanted prosthesis or repaired valve.
Time frame: At one year
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Affiliated Hospital of Zunyi Medical University
Zunyi, China