This study was designed to preliminary verify the safety and of efficacy of SinocrownTM Transcatheter Aortic Valve Replacement System With accessories in patients with symptomatic, calcified and severe aortic stenosis using objective performance criteria
This prospective, single-center, single-arm clinical trial was designed to preliminary confirm the safety and efficacy of SinocrownTM transcatheter aortic valve system with accessories. According to the inclusion and exclusion criteria, 10 patients were enrolled and implanted with SinocrownTM .Patients will been followed up 30 days, 6 months, 12 months, 2 years, 3 years, 4 years and 5 years after valve implantation. The main follow-up included clinical symptoms and signs, cardiac ultrasound, etc. The primary endpoint was device success after TAVR, Secondary endpoints included procedural success, all-cause mortality, myocardial infarction, disabling stroke, severe bleeding, acute kidney injury, permanent pacemaker implantation, vascular complications, other complication, MACCEs, valvular function , cardiac function improvement, quality of life of patients.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Subjects receiving SinocrownTM Transcatheter Aortic Valve Replacement System of Lepu Medical
Hefei High-tech Cardiovascular hospital
Hefei, Anhui, China
device success
Immediate postoperative device success was defined as : successfully loading the valve into the delivery system, sending it to the target site through the delivery system, accurately releasing the artificial aortic valve and completely withdrawing the delivery system (valve orifice area \> 1.2cm2, mean aortic gradient\< 20mmhg or maximal aortic valve velocity \< 3 m/ s, and there is no moderate or severe valve stenosis)
Time frame: immediate post-surgical
Procedural success
Device success without death and aortic valve reintervention during operation
Time frame: immediate post-surgical
All-cause mortality
including cardiac, non-cardiac and unexplained deaths
Time frame: immediate post-surgical, 7 days after procedure/prior to discharge, 30 days, 6 months, 12 months, 2 years, 3 years, 4 years and 5 years
Myocardial infarction
Rate of patients with myocardial infarction
Time frame: immediate post-surgical, 7 days after procedure/prior to discharge, 30 days, 6 months, 12 months, 2 years, 3 years, 4 years and 5 years
Rate of disabling stroke
Disabling stroke was defined as mRS ≥ 2, and the mRS score increased by more than 1 point compared with the last visit
Time frame: 7 days after procedure/prior to discharge, 30 days, 6 months, 12 months, 2 years, 3 years, 4 years and 5 years
Rate of Severe bleeding(life-threatening or disabling)
Severe degree was defined as type 3a or above(according to BARC)
Time frame: 7 days after procedure/prior to discharge, 30 days, 6 months, 12 months, 2 years, 3 years, 4 years and 5 years
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acute kidney injury
Rate of patients with acute kidney injury
Time frame: 7 days after procedure/prior to discharge, 30 days after procedure
permanent pacemaker implantation
Rate of patients implanted with permanent pacemaker
Time frame: 7 days after procedure/prior to discharge, 30 days, 6 months, 12 months, 2 years, 3 years, 4 years and 5 years
vascular complications
Vascular complications mainly include dissection, occlusion, rupture and bleeding of access vessels.
Time frame: immediate post-surgical, 7 days after procedure/prior to discharge
other operative complication
including conversion to surgery, unexpected cardiopulmonary mechanical assistance, coronary artery occlusion, ventricular septal perforation, mitral valve injury or loss of function, pericardial tamponade, endocarditis, valve thrombosis, valve ectopic (displacement, embolization, misrelease), and so on.
Time frame: immediate post-surgical, 7 days after procedure/prior to discharge
The incidence of major adverse cardiovascular and cerebrovascular events during the trial(MACCEs)
Incidence of MACCEs (including mortality, stroke, myocardial infarction, reoperation, arrhythmias and conduction blocks) during the trial.
Time frame: immediate post-surgical, 7 days after procedure/prior to discharge, 30 days, 6 months, 12 months, 2 years, 3 years, 4 years and 5 years
Valve and heart function
Doppler echocardiography was used to evaluate the valve performance at each follow-up point, including valve orifice area, mean aortic gradient, degree of valve regurgitation, left ventricular ejection fraction LVEF, end diastolic left ventricular inner diameter LVEDd, moderate or above perivalvular leakage PVL, and degree of aortic stenosis.
Time frame: immediate post-surgical, 7 days after procedure/prior to discharge, 30 days, 6 months, 12 months
Cardiac function improvement
Cardiac function improvement is accessed by NYHA cardiac function classification increases from baseline to discharge, 30 days, 6 months, 12 months
Time frame: 7 days after procedure/prior to discharge, 30 days, 6 months, 12 months
Quality of life of patients
Quality of Life of patients accessed by EuroQol-5 Dimensions (EQ-5D) Questionnaire. The higher scores mean a better health state. Recording changes from baseline to 30 days, 6 months, 12 months
Time frame: 30 days, 6 months, 12 months