To Evaluate Safety and Effectiveness of Transcatheter Aortic Valve System in Patients With Severe Symptomatic Aortic Insufficiency
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Aortic Insufficiency
- Sponsor
- Chengdu Silara Meditech Inc.
- Enrollment
- 10
- Primary Endpoint
- Rate of Procedure success
- Last Updated
- 3 years ago
Overview
Brief Summary
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
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.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Rate of Procedure success
Time Frame: Immediate post procedure
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.
Rate of none or trace AR
Time Frame: 30 days
Rate of Device success
Time Frame: Immediate post- procedure
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
Rate of All cause mortality,including Cardiac death, non-cardiac death and unexplained death
Time Frame: 30 days
Percentage of subjects who died from all causes in this population
Incidence of MACCE
Time Frame: 30 days
MACCE includs death, stroke, MI, re-procedure, conduction disturbances and cardiac arrhythmias
Secondary Outcomes
- Quality of Life Assessment(30 days, 6 months,and 12 months)
- Incidence of Myocardial Infarction(immediate post- procedure, 7 days /discharge, 30 days, 6 months and 12months)
- Retrieval system performance (if need)(Immediate post-procedure)
- Valvular function evaluation, including valve stenosis, AR, valve function(e.g. EOA, gradient) and PVL(Immediate post-procedure, 7 days or discharge, 30 days, 6 months and 12months)
- Incidence of AKI(7 days /discharge, 30 days, 6 months and 12 months)
- Delivery system performance(Immediate post-procedure)
- All-cause Mortality(Immediate post- procedure ,7 days /discharge, 6 months and 12 months)
- Incidence of MACCE(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)
- Exchange system evaluation(Immediate post-procedure)
- NYHA function(7 days or discharge, 30 days, 6 months ,12 months)
- Incidence of stroke(7 days /discharge, 30 days, 6 months and 12 months)
- Incidence of other TAVI-related complications(at immediate post- procedure, 7 days /discharge, 30 days, 6 months, 12 month)
- Rate of moderate to severe AR(immediate post- procedure ,7 days /discharge, 6 months and 12 months)
- Incidence of Permanent Pacemaker Implantation(7 days /discharge, 30 days, 6 months and 12 months)
- Incidence of Conduction disturbances and cardiac arrhythmias(Immediate post- procedure, 7 days /discharge, 30 days, 6 months, 12 months)
- Incidence of major vascular complications(Immediate post- procedure, 7 days /discharge, 30 days, 6 months, 12 months)