This clinical study is a prospective、single arm and exploratory study, to explore the feasibility and safety of MitrAssist TRISKELE® transcatheter aortic valve system in the treatment of patients with severe aortic stenosis.
This study was a prospective、single arm clinical trial design. For patients with surgical contraindications or high-risk symptomatic severe aortic stenosis, MitrAssist TRISKELE® transcatheter aortic valve system was performed by aortic valve replacement. Patients were followed up 30 days (± 7 days) after operation for the feasibility and safety analysis to explore the test device in patients with surgical contraindications or high-risk symptomatic severe aortic stenosis.In this study, a clinical trial institution meeting the national qualification is planned to be selected as the clinical research center, and 7 patients are planned to be selected. The success rate of operation 30 days after operation was taken as the main evaluation index and the success of device implantation, the result of echocardiography evaluation of valve function, the improvement rate of NYHA cardiac function classification, six minute walking distance and the score of Kansas City Cardiomyopathy Questionnaire were taken as the secondary evaluation indexes, to evaluate clinical effectiveness of TRISKELE® transcatheter aortic valve system; Adverse events, serious adverse events, major cardiovascular and cerebrovascular adverse events, device defects, vital signs and laboratory examination results were used as safety indicators to evaluate the safety of the test device .
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
7
Patients were treated with MitrAssist TRISKELE® transcatheter aortic valve system
Zhongshan Hopital of Fudan University
Shanghai, Shanghai Municipality, China
RECRUITINGTechnical success
Freedom from mortality; Successful access, delivery of the device, and retrieval of the delivery System; Correct positioning of a single prosthetic heart valve into the proper anatomical location; Freedom from surgery or intervention related to the device or to a major vascular or access-related, or cardiac structural complication
Time frame: at exit from procedure room
Device success
Technical success; Freedom from mortality; Freedom from surgery or intervention related to the device or to a major vascular or access-related or cardiac structural complication; Intended performance of the valve (mean gradient \<20 mmHg, peak velocity\<3 m/s, Doppler velocity index ≥0.25, and less than moderate aortic regurgitation)
Time frame: within 30 days after operation
Early safety endpoint
Freedom from all-cause mortality; Freedom from all stroke; Freedom from VARC type 2-4 bleeding (in trials where control group is surgery, it is appropriate to include only Type 3 and 4 bleeding); Freedom from major vascular, access-related, or cardiac structural complication; Freedom from acute kidney injury stage 3 or 4; Freedom from moderate or severe aortic regurgitation; Freedom from new permanent pacemaker due to procedure-related conduction abnormalities; Freedom from surgery or intervention related to the device
Time frame: within 30 days after operation
six minute walk distance (6MWD) test
The six minute walk distance (6MWD) test (see Appendix II) was used to record the patients' six minute walk distance before operation and 30 days after operation. The six minute walk test is mainly used to evaluate the efficacy of treatment intervention in patients with moderate and severe cardiovascular diseases, and can objectively reflect the actual daily activity ability
Time frame: within 30 days after operation
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
The quality of life improved 30 days after operation
SF-12 quality of life table was used to score the cardiac function improvement before discharge and 30 days after operation. NYHA classification scheme was adopted for the classification of cardiac function.
Time frame: within 30 days after operation