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

Chengdu Silara Meditech Inc.10 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Aortic Insufficiency

Interventions

Transcatheter Aortic Valve SystemDEVICE

Procedure: Transcatheter Aortic Valve Replacement

Eligibility

Sex: ALLMin age: 60 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Age ≥ 60 years old; 2. Subjects with symptomatic severe aortic valve regurgitation. 3. NYHA Functional Class ≥II. 4. Life expectancy after aortic valve implantation thought to be \>1 year， 5. Native valvular or peripheral vascular anatomy is appropriate for TAVR. 6. 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. 7. 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: 1. 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 2. 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). 3. Any treatment for traumatic cardiac surgery within 30 day prior to the study procedure(except coronary revascularization). 4. 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. 5. Severe ventricular insufficiency. Left ventricular ejection fraction (LVEF) \<20%. 6. Echocardiographic evidence of intra-cardiac thrombus or vegetation etc. 7. Active pepticulcer or upper GI bleeding within 3 months prior to the study procedure. 8. Cerebral Vascular Accident (CVA) within 3 months prior to the study procedure,including TIA. 9. 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. 10. 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 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

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

Rate of none or trace AR

Time frame: 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

Time frame: 30 days

Incidence of MACCE

MACCE includs death, stroke, MI, re-procedure, conduction disturbances and cardiac arrhythmias

Time frame: 30 days

Secondary Outcomes

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 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.

Central Contacts

Yang Liu

CONTACT

+86 13519135591 liuyangxijing@126.com

Data from ClinicalTrials.gov

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