The purpose of this study is to demonstrate that transcatheter artificial aortic valve and transcatheter artificial heart values delivery system is associated with a reduction of all-cause mortality in severe aortic stenosis or insufficiency patients who are high risk or ineligible for aortic valve replacement.
Aortic valve diseases is usually caused by rheumatic fever, congenital aortic valve structural abnormality or degenerative aortic valve calcification. Transcatheter aortic valve implantation (TAVI) has evolved as an alternative to surgical aortic valve replacement (SAVR) with now more than 50,000 implantations in patients with symptomatic severe aortic stenosis, who were considered to be at very high or prohibitive operative risk. This project take the incidence of all-cause mortality at 12 months since TAVI as the primary endpoint to evaluate the safety and efficacy, then take the procedure success rate, device success rate, incidence of severe adverse events, device operative performance, prosthetic valve performance and quality of life to evaluate transcatheter artificial aortic valve and transcatheter artificial heart values delivery system of Ningbo Jenscare Biotechnology Co., Ltd. in clinical application.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
133
Jenscare TAVI and delivery system will implant a percutaneous bioprosthesis value, which is positioned in the native aortic valve, plays a role to control blood flow, and help your heart to work better. It may also shorten your recovery time to getting back to everyday activities.
All-cause mortality
Cumulative incidence of a combination of all cause death at 12 month after TAVI
Time frame: 12 month
Procedure success rate
Documentation of no death occurred during or within 72 hours after TAVI, no conversion to conventional cardiopulmonary bypass, the value was placed in the correct anatomical position and achieve the desired effect
Time frame: During the TAVI procedure
Device success rate
Documentation of the device was implanted successfully, placed in the correct anatomical position and achieve the desired effect
Time frame: During the TAVI procedure
Incidence of severe adverse events
Documentation of the serious long-term complications, including mortality, stroke, transient ischemic stroke, myocardial infarction, dialysis and reinterventions
Time frame: During the TAVI procedure and 3 days,7 days, 30 days, 3 months, 6 months, 12 months after TAVI
Assessment of device operative performance
Using the following measure (loading and releasing properties of artificial aortic valve; pushing, emptying, withdrawing, developing performance, fracture of the delivery system) that can be converted to utilities using an algorithm. Utilities range from 1 to 3, with 3 representing perfect performance, and 1 corresponding to the worst performance state.
Time frame: During the TAVI procedure
Echocardiographic assessment of valve performance
Using the following measures: effective orifice area (EOA)
Time frame: 30 days, 3 months, 6 months, 12 months after TAVI
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Echocardiographic assessment of valve performance
Using the following measures: transvalvular mean gradient
Time frame: 30 days, 3 months, 6 months, 12 months after TAVI
Evaluation and improvement of quality of life
Measures 5 domains (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) that can be converted to utilities using an algorithm. Utilities range from 0 to 1, with 1 representing perfect health, and 0 corresponding to the worst imaginable health state.
Time frame: Preoperative and 30 days, 3 months, 6 months, 12 months after TAVI
Echocardiographic assessment of valve performance
Using the following measures: peak flow velocity
Time frame: 30 days, 3 months, 6 months, 12 months after TAVI
Echocardiographic assessment of valve performance
Using the following measures: degree of aortic valve regurgitation
Time frame: 30 days, 3 months, 6 months, 12 months after TAVI
Echocardiographic assessment of valve performance
Using the following measures: degree of perivalvular leakage
Time frame: 30 days, 3 months, 6 months, 12 months after TAVI