symptomatic heart disease due to severe aortic stenosis
Conditions
Interventions
Sponsors
Medical ethic committee of The Second Affiliated Hospital Zhejiang University School
Eligibility
Sex/Gender
All
Age
65 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age>= 65 years; 2. Cardiac function NYHA >= II; 3. Patients with symptomatic severe aortic valve stenosis (evaluated by echocardiography: transaortic valve pressure gradient >= 40mmHg (1mmHg=0.133kPa), or transaortic valve blood flow rate >= 4m/s, or aortic Valve area = 6%; (2) Presence of any two of the following irreversible organ function damage like heart disease, brain disease, pulmonary disease, liver disease, renal disease, blood coagulation disorders, cancer; (3) The patient is weak and intolerant to surgical aortic valve replacement; (4) Surgical operation difficulties like thoracocyllosis, Vitrified aorta, post CABG; 5.The patient understands the objective of the study and is willing to enroll in the study by signing a patient informed consent and agreeing to clinical examination and the scheduled follow up requirement.
Exclusion criteria
Exclusion criteria: 1. Congenital single leaf aortic valve,Non-calcified valves; 2. Severe aortic diseases, including abdominal aortic or thoracic aortic aneurysm, obvious curvature of the aortic arch, atherosclerosis of the aortic arch, narrowing of the abdominal or thoracic aorta, and obvious curvature or extension of the thoracic aorta; 3. The patient's heart has been implanted with other artificial heart valves; 4. Patients with other valvular diseases that require simultaneous intervention; 5. Untreated severe coronary artery stenosis that requires revascularization; 6. The echocardiogram indicates the presence of a heart mass, thrombus or vegetation; 7. Active infective endocarditis; 8. Severe left ventricular dysfunction, left ventricular ejection fraction (LVEF) 177umol/L), and/or end-stage renal disease requires long-term dialysis; 18. Are allergic to cobalt-chromium alloys or contrast agents, and cannot tolerate anticoagulation and antiplatelet therapy; 19. Those who have participated in clinical trials of other drugs or medical devices before entering the group and have not yet reached the time limit of the primary research endpoint; 20. Anatomical features or other situations are not suitable for transcatheter implantation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| All-cause mortality at 12 momths; | — |
Secondary
| Measure | Time frame |
|---|---|
| Technical success rate;Rate of device success;Evaluation of valves and cardiac function;NYHA functional classification improved;score improved of KCCQ; | — |
Countries
China
Contacts
Public ContactJian'an Wang
Outcome results
None listed