To Evaluate Safety and Effectiveness of Transcatheter Aortic Valve System in Patients With Severe Aortic Insufficiency

Study Overview
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Brief Summary
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To Evaluate the Safety and Effectiveness of Transcatheter Aortic Valve System ( Chengdu Silara Medtech Inc. ,Chengdu, China)in Patients with Severe Symptomatic Aortic Insufficiency

Detailed Description
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Transcatheter Aortic Valve System (Chengdu Silara Medtech Inc. ,Chengdu, China) will be used for this study. To evaluate the feasibility , safety and effectiveness of Transcatheter aortic valve system.

Official Title
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To Evaluate Safety and Effectiveness of Transcatheter Aortic Valve System in Patients With Severe Symptomatic Aortic Insufficiency

Conditions
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Aortic Insufficiency

Intervention / Treatment
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* Device: Transcatheter Aortic Valve System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 60 years old; Subjects with symptomatic severe aortic valve regurgitation. NYHA Functional Class ≥II. Life expectancy after aortic valve implantation thought to be >1 year， Native valvular or peripheral vascular anatomy is appropriate for TAVR. Patient is assessed by at least two cardiothoracic surgeons and recorded as not suitable for surgery (defined as a risk of operative mortality after 30 days>50%，or severe irreversible comorbidities or other factors affecting surgery (e.g., porcelain aorta, frailty, chest malformation, severe liver disease, severe lung disease, etc.)), or patients at high risk of surgery（Euroscore≥20%, or STS≥8）,or patient not agree open surgery. Patient can understand the purpose of the study, voluntarily participates and signs the informed consent form and is willing to accept the relevant examination and clinical follow-up visits. Exclusion Criteria: Anatomy is not appropriate for percutaneous valve implantation. Native valve annulus diameter is not in the scope of application(native TAV diameter ≤20mm,or ≥28mm Evidence of an acute myocardial infarction within 30 days prior to the study procedure, defined as: Q-wave myocardial infarction, or non-Q-wave myocardial infarction, with CK-MB≥ 2x normal and/or elevated Tn (WHO definition). Any treatment for traumatic cardiac surgery within 30 day prior to the study procedure(except coronary revascularization). Hematological abnormality, defined as: Leukopenia (WBC <3×109/L), acute anemia (Hb <90g/L), or thrombocytopenia (platelet count<50×109/L), history of bleeding diathesis or coagulopathy. Severe ventricular insufficiency. Left ventricular ejection fraction (LVEF) <20%. Echocardiographic evidence of intra-cardiac thrombus or vegetation etc. Active pepticulcer or upper GI bleeding within 3 months prior to the study procedure. Cerebral Vascular Accident (CVA) within 3 months prior to the study procedure,including TIA. A known hypersensitivity or contraindication to aspirin, heparin, ticlopidine , clopidogrel and high polymer material, or sensitivity to contrast media, which cannot be adequately pre-medicated. Patients with infective endocarditis or other active stage of infection. Currently participating in an investigational drug or another device trial.

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Severe Symptomatic Aortic Regurgitation<br>Patients will be treated with transcatheter aortic valve system | Device: Transcatheter Aortic Valve System<br>* Procedure: Transcatheter Aortic Valve Replacement<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Device success | Device Success is defined as a composite of : Absence of procedural mortality AND Successful vascular access, delivery and deployment of the device, and successful retrieval of the delivery system AND Correct positioning of prosthetic heart valve into the proper anatomical location AND Intended performance of the prosthetic heart valve (mean aortic valve gradient<20 mmHg or peak velocity<3 m/s, and no moderate or more prosthetic valve regurgitation | 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. | Immediate post procedure | 
| Rate of none or trace AR |  | 30 days | 
| Rate of All cause mortality,including Cardiac death, non-cardiac death and unexplained death | Percentage of subjects who died from all causes in this population | 30 days | 
| Incidence of MACCE | MACCE includs death, stroke, MI, re-procedure, conduction disturbances and cardiac arrhythmias | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Immediate post-procedure | 
| Retrieval system performance (if need) | Retrieval System Performance wil be evaluated subjectively by the researchers participating in the operation, which is generally classified as excellent, good ,average and poor. | Immediate post-procedure | 
| Exchange system 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. | 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 | Immediate post-procedure, 7 days or discharge, 30 days, 6 months and 12months | 
| Quality of Life Assessment | SF-12 | 30 days, 6 months,and 12 months | 
| NYHA function |  | 7 days or discharge, 30 days, 6 months ,12 months | 
| All-cause Mortality |  | Immediate post- procedure ,7 days /discharge, 6 months and 12 months | 
| Rate of moderate to severe AR |  | immediate post- procedure ,7 days /discharge, 6 months and 12 months | 
| Incidence of Myocardial Infarction |  | immediate post- procedure, 7 days /discharge, 30 days, 6 months and 12months | 
| Incidence of MACCE | including death, stroke, MI, re-procedure, Conduction disturbances and cardiac arrhythmias | Immediate post- procedure, 7 days /discharge, 6 months and 12months. | 
| Incidence of Bleeding(life-threatening or disabling and major) |  | Immediate post- procedure, 7 days /discharge, 30 days, 6 months and 12 months | 
| Incidence of stroke |  | 7 days /discharge, 30 days, 6 months and 12 months | 
| Incidence of AKI | including AKIN stage 2 and 3,or renal replacement therapy (RRT:Hemodialysis, abdomen Cavity dialysis, hemofiltration) | 7 days /discharge, 30 days, 6 months and 12 months | 
| Incidence of Permanent Pacemaker Implantation |  | 7 days /discharge, 30 days, 6 months and 12 months | 
| Incidence of major vascular complications |  | Immediate post- procedure, 7 days /discharge, 30 days, 6 months, 12 months | 
| Incidence of Conduction disturbances and cardiac arrhythmias |  | Immediate post- procedure, 7 days /discharge, 30 days, 6 months, 12 months | 
| 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 | at immediate post- procedure, 7 days /discharge, 30 days, 6 months, 12 month |