Aortic Insufficiency
Conditions
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.
Interventions
Procedure: Transcatheter Aortic Valve Replacement
Sponsors
Chengdu Silara Meditech Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Device success | 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 Procedure success | 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 | 30 days | — |
| Rate of All cause mortality,including Cardiac death, non-cardiac death and unexplained death | 30 days | Percentage of subjects who died from all causes in this population |
| Incidence of MACCE | 30 days | MACCE includs death, stroke, MI, re-procedure, conduction disturbances and cardiac arrhythmias |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Immediate post- procedure, 7 days /discharge, 6 months and 12months. | including death, stroke, MI, re-procedure, Conduction disturbances and cardiac arrhythmias |
| Incidence of Bleeding(life-threatening or disabling and major) | Immediate post- procedure, 7 days /discharge, 30 days, 6 months and 12 months | — |
| Delivery system performance | Immediate post-procedure | Delivery System Performance wil be evaluated subjectively by the researchers participating in the operation, which is generally classified as excellent, good ,average and poor. |
| Incidence of AKI | 7 days /discharge, 30 days, 6 months and 12 months | including AKIN stage 2 and 3,or renal replacement therapy (RRT:Hemodialysis, abdomen Cavity dialysis, hemofiltration) |
| 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 | at immediate post- procedure, 7 days /discharge, 30 days, 6 months, 12 month | 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 |
| Incidence of stroke | 7 days /discharge, 30 days, 6 months and 12 months | — |
| Retrieval system performance (if need) | Immediate post-procedure | Retrieval System Performance wil be evaluated subjectively by the researchers participating in the operation, which is generally classified as excellent, good ,average and poor. |
| Exchange system evaluation | Immediate post-procedure | Exchange Systerm Evaluation wil be evaluated subjectively by the researchers participating in the operation, which is generally classified as excellent, good ,average and poor. |
| 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 | The evaluation criteria refer to the 2012 edition of the Association for Valvular Academic Research (VARC-2) consensus document |
| Quality of Life Assessment | 30 days, 6 months,and 12 months | SF-12 |
Contacts
Primary ContactYang Liu
Outcome results
None listed