severe aortic stenosis
Conditions
Interventions
Observation group:NA
Sponsors
Qilu Hospital of Shandong University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients with severe aortic stenosis diagnosed at the clinic: peak transvalvular flow velocity >=4.0m/s, or mean transvalvular pressure difference >=40mmHg(1 mmHg=0.133kPa), or aortic valve orifice area < <0.8cm^2 (or effective aortic valve orifice area index < 0.5 cm^2/m^2); 2. Meet one of the following emergent TAVR indications: 1) Shock; 2) Combined with persistent ventricular tachycardia or ventricular fibrillation; 3) Difficulty in improving unstable angina pectoris or chronic heart failure requiring mechanical circulatory assistance with drugs; 4) Cardiopulmonary resuscitation is required for cardiac arrest; 3. Patients who can understand the purpose of the study, voluntarily participate in and sign the informed consent form, and are willing to accept the relevant examinations and clinical follow-up.
Exclusion criteria
Exclusion criteria: 1. Aortic root anatomy and lesions are not suitable for prosthetic valve implantation; 2. Anatomic morphology or vascular diseases affecting the instrument approach; 3. Left ventricular outflow tract obstruction; 4. Primary dilated cardiomyopathy; 5. Thrombus in the left ventricle; 6. Patients who are unable to receive anticoagulation or antiplatelet therapy; 7. Allergy to or resistance to Nitinol; 8. Active stage of infective endocarditis or other infection that the researcher believes affects the operation; 9. Severe disability senile dementia; 10. Patients with a life expectancy of less than half a year; 11. The investigator determined that the patient or family had poor compliance or declined to complete the study as required.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cumulative all-cause mortality at 12 months postoperatively, All-cause death includes cardiac death and non-cardiac death; | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of Major Adverse Cardiac and Cerebrovascular Events (MACCE) ;Immediate device success rate after surgery;Mechanical circulation assist device (MCS) implantation;Incidence of Acute Kidney Injury;Incidence of Permanent Pacemaker Implantation;Incidence of severe vascular complications;Incidence of other TAVR related complications;Valve Function, Improvement in Cardiac Function; | — |
Countries
China
Contacts
Public ContactYuguo Chen ;Chuanbao Li
Qilu Hospital of Shandong University
Outcome results
None listed