Aortic stenosis
Conditions
Interventions
experimental group:The subjects underwent aortic valve implantation using the Venus A-plus system
Sponsors
The Second Affiliated Hospital, Zhejiang University School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Degenerative aortic stenosis (including autologous aortic valve and artificial aortic valve bivalve with severe impairment of function): mean pressure difference measured by echocardiography >= 40mm Hg; or aortic peak ejection >= 4.0m /s; or aortic valve orifice area = 4% or significant surgical contraindications as determined by the investigator.
Exclusion criteria
Exclusion criteria: 1. subjects were offered surgery but refused surgical treatment; 2. evidence of acute myocardial infarction within one month (defined as: q-wave myocardial infarction, or non-q-wave myocardial infarction, with ck-mb >= twice normal and/or elevated Tn (defined by WHO); 3. aortic valve is one of congenital single-valve or non-calcified valve or two-valve malformation with the following conditions: severe and diffuse calcification in bilateral lobes, especially in contralateral lobes, with severe asymmetry in bilateral lobes; involvement of the valve lobe junction severely restricts valve movement; it is estimated that the implanted valve will not work properly; ascending aorta dilatation >= 50mm. 4. complex aortic valve lesions (>3+ for aortic sclerosis and aortic regurgitation); 5. had any therapeutic traumatic cardiac surgery within 30 days (in the case of DES implantation, the decision was made by the clinical investigator based on clinical need); 6. artificial heart valves placed in any location (except for the aortic valve biological valve with severe impairment of function), artificial rings, severe mitral ring calcification (MAC), severe (>3+) mitral insufficiency, or Gorelin syndrome; 7. hematologic abnormalities were defined as: leucopenia (WBC 32mm was measured by echocardiography; 17. cerebrovascular events (CVA) within 6 months included TIA; 18. patients with renal insufficiency (creatinine > 3.0mg/dl) and/or advanced renal disease requiring renal dialysis were determined by the inestigators after a thorough analysis; 19. life expectancy 5 mm, bulge or ulcer), abdominal or thoracic aortic stenosis (especially the irregular calcification and surface), severe thoracic aorta "unfolding" and distorted; 21. the iliofulmonary iliofulmonary artery is unable to place the guiding sheath of 18F~20F, such as severe obstructive calcification, severe distortion, or vessels smaller than 5.8mm in diameter; 22. participate in other drug or device studies as well; 23. active phase of infective endocarditis or other active infections; 24. calcified plaques in the aortic valve lobes close to the coronary orifice.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The combined incidence of all-cause death, severe stroke, myocardial infarction, permanent pacemaker placement, and surgical intervention at 30 days after surgery; | — |
Secondary
| Measure | Time frame |
|---|---|
| All Cause Mortality or Major Stroke;NYHA;The 30-day incidence of non-macce events;Cardiogenic mortality;Heart function;Valve performance;Operational success rate;Success rate of operation upon discharge; | — |
Countries
China
Contacts
Public ContactWang Jian'an
The Second Affiliated Hospital, Zhejiang University School of Medicine
Outcome results
None listed