Severe aortic valve stenosis
Conditions
Interventions
experimental group:TAVI
Sponsors
Fuwai Hospital Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged >=70 years; 2. Symptomatic severe aortic stenosis determined by echocardiogram, defined as: mean gradient >=40 mmHg or peak jet velocity >= 4.0 m/s, or an aortic valve area =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; 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
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 =30mm); 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>=2 ULN/or elevated TN (WHO definition); 3. Any treatment for traumatic cardiac surgery within 30 day prior to the study procedure(except coronary revascularization); 4. Pre-existing prosthetic valve in any position(except severely dysfunctional aortic bioprosthesis), or severe (>3+) mitral insufficiency, or Gorelin syndrome; 5. Hematological abnormality, defined as: Leukopenia (WBC <3x10^9/L), acute anemia (Hb <90g/L), or thrombocytopenia (platelet count<50x10^9/L),history of bleeding diathesis or coagulopathy; 6. Hemodynamic unstable requiring myocardial contractile support or mechanical cardiac assistance; 7. Severe ventricular insufficiency. Left ventricular ejection fraction (LVEF) <20%; 8. Echocardiographic evidence of intra-cardiac thrombus or vegetation etc.; 9. Active pepticulcer or upper GI bleeding within 3 months prior to the study procedure; 10. Cerebral Vascular Accident (CVA) within 3 months prior to the study procedure, including TIA; 11. A known hypersensitivity or contraindication to aspirin, heparin, ticlopidine or clopidogrel, or sensitivity to contrast media, which cannot be adequately pre-medicated; 12. Patients with infective endocarditis or other active stage of infection; 13. Currently participating in an investigational drug or another device trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| all-cause mortality from procedure to 12 months; | — |
Secondary
| Measure | Time frame |
|---|---|
| device success;procedure success;delivery system performance;Retrieval System Performance;Exchange Systerm Evaluation;valvular function evaluation, including valve stenosis, AR, valve function(e.g. EOA, gradient) and PVL at immediate post-procedure, 7days or discharge, 30 days, 6 months and annually 1 through 5 years;Quality of life improvement at 30 days, 6 months,and 12 months;NYHA function;All-cause mortality;Incidence of myocardial infarction;Incidence of MACCE(including mortality, stroke, MI, re-procedure, Conduction disturbances and cardiac arrhythmias) at immediate post- procedure ,7 days /discharge, 30 days, 6 months, 12 months and 2-5 years.;Incidence of Bleeding (life-threatening or disabling and major);Incidence of Stroke;Incidence of AKI (stage 2 and 3,or renal replacement therapy (RRT: Hemodialysis, abdomen Cavity dialysis, hemofiltration));Incidence of Permanent Pacemaker Implantation;Incidence of major vascular complications;Incidence of Conduction disturbances and cardiac arrhythmias;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); | — |
Countries
China
Contacts
Public ContactRunlin Gao
Fuwai Hospital
Outcome results
None listed