To Evaluate the Safety and Effectiveness of Transcatheter Aortic Valve System ( Chengdu Silara Medtech Inc. ,Chengdu, China)in Patients with Severe Aortic Stenosis with or without Moderate or Lower Degree Regurgitation
Transcatheter Aortic Valve System (Chengdu Silara Medtech Inc. ,Chengdu, China) will be used for this study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
120
Procedure: Transcatheter aortic valve replacement
Fuwai Hospital, CAMS&PUMC
Beijing, China
RECRUITINGRate of All-cause Mortality
Percentage of subjects who died from all causes in this population.
Time frame: 12 months
Rate of Device Success
Device Success is defined as a composite of : 1. Absence of procedural mortality AND 2. Successful vascular access, delivery and deployment of the device, and successful retrieval of the delivery system AND 3. Correct positioning of prosthetic heart valve into the proper anatomical location AND 4. Intended performance of the prosthetic heart valve (mean aortic valve gradient\<20 mmHg or peak velocity\<3 m/s, and no severe prosthetic valve regurgitation or PVL)
Time frame: Immediate post- procedure
Rate of Procedure Success
Procedure Success is defined as no death, stroke, myocardial infarction and renal failure occurred within 72 hours after the operation on the basis of the final device success.
Time frame: Immediate post- procedure
Delivery System Performance
Delivery System Performance wil be evaluated subjectively by the researchers participating in the operation, which is generally classified as excellent, good ,average and poor.
Time frame: Immediate post- procedure
Retrieval System Performance(if using)
Retrieval System Performance wil be evaluated subjectively by the researchers participating in the operation, which is generally classified as excellent, good ,average and poor.
Time frame: Immediate post- procedure
Exchange Systerm Evaluation
Exchange Systerm Evaluation wil be evaluated subjectively by the researchers participating in the operation, which is generally classified as excellent, good ,average and poor.
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Time frame: Immediate post- procedure
Valvular function evaluation, including valve stenosis, AR, valve function(e.g. EOA, gradient) and PVL
The evaluation criteria refer to the 2012 edition of the Association for Valvular Academic Research (VARC-2) consensus document
Time frame: Immediate post-procedure, 7days or discharge, 30 days, 6 months ,12months and 2-5 years
Quality of Life Assessment
SF-12
Time frame: 30 days, 6 months,and 12 months
NYHA function
Time frame: 7 days or discharge, 30 days, 6 months ,12 months and 2-5 years
Rate of All-cause Mortality
Time frame: Immediate post- procedure ,7 days /discharge, 30 days, 6 months and 2-5 years.
Incidence of Myocardial Infarction
Time frame: Immediate post- procedure, 7 days /discharge, 30 days, 6 months ,12months and 2-5 years.
Incidence of MACCE(including mortality, stroke, MI, re-procedure, Conduction disturbances and cardiac arrhythmias)
Time frame: Immediate post- procedure, 7 days /discharge, 30 days, 6 months,12months and 2-5 years.
Incidence of Bleeding (life-threatening or disabling and major)
Time frame: Immediate post- procedure, 7 days /discharge, 30 days, 6 months,12months and 2-5 years.
Incidence of Stroke
Time frame: 7 days /discharge, 30 days, 6 months, 12 months and 2-5 years.
Incidence of AKI (stage 2 and 3,or renal replacement therapy (RRT: Hemodialysis, abdomen Cavity dialysis, hemofiltration))
Time frame: 7 days /discharge, 30 days, 6 months, 12 months and 2-5 years.
Incidence of Permanent Pacemaker Implantation
Time frame: 7 days /discharge, 30 days, 6 months, 12 months and 2-5 years.
Incidence of major vascular complications
Time frame: Immediate post- procedure, 7 days /discharge, 30 days, 6 months, 12 months.
Incidence of Conduction disturbances and cardiac arrhythmias
Time frame: Immediate post- procedure, 7 days /discharge, 30 days, 6 months, 12 month and 2-5years
Incidence of Other TAVI-related Complications
including transfer to surgery , Accidental heart-lung machine, coronary obstruction, ventricular septal rupture, Mitral valve damage or dysfunction,cardiac tamponade,endocarditis ,valvular thrombus,Valve migration(shifting, detachment,embolism,error deployment),valve in valve
Time frame: Immediate post- procedure, 7 days /discharge, 30 days, 6 months, 12 month and 2-5years