Moderate to high risk severe aortic stenosis
Conditions
Interventions
Balloon expanded transcatheter aortic valve system group:The ball dilated transcatheter aortic valve system is used in patients with moderate to high risk and severe aortic stenosis
Sponsors
The Second Affiliated Hospital of Air Force Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Surgical contraindications as assessed by cardiac surgeons, or high-risk surgery (STS>=8%), or other conditions that are not suitable for surgical valve replacement, or patient age>=70 years old; Surgical intermediate-risk and intermediate-risk patients (60-69 years old) who meet one of the relevant conditions for patients with severe aortic stenosis over 70 years old; 2. Patients with symptomatic severe aortic stenosis (echocardiography shows that the average transvalvular pressure difference between the aortic valve is >=40mmHg (1mmHg=0.133kPa), or the transaortic valve blood flow velocity is >=4.0m/s, or the aortic orifice area <1.0cm², or the effective aortic orifice area index (0.6cm²/m²); 3. Patients who can understand the purpose of the trial, voluntarily participate in and sign the informed consent form, and are willing to accept relevant examinations and clinical follow-up
Exclusion criteria
Exclusion criteria: 1. Those who have a life expectancy of less than 1 year after implantation of an artificial valve Those who have had acute myocardial infarction within 2 or 2 months, or have been implanted with coronary stents, or have been implanted with cardiac pacing devices, or have undergone any therapeutic cardiac surgery 3. There is no obvious calcification of the aortic annulus 4. Patients whose aortic root anatomy and lesions are not suitable for prosthetic valve implantation 5. Multivalvular lesions (severe stenosis or/and regurgitation) 6. Hematocachexia, including granulocytopenia (WBC<3x10?/L), acute anemia (HB<90g/L), thrombocytopenia (PLT<50x10?/L), hemorrhagic constitution and coagulation disorders 7. Those who need emergency surgery for any reason 8. Obstructive hypertrophic cardiomyopathy 9. Severe right ventricular dysfunction 10. Echocardiography shows the presence of intracardiac mass, thrombus or vegetation 11. Those who cannot tolerate anticoagulation and antiplatelet therapy Cerebrovascular events (CVA) occurred within 12 or 3 months, including ischemic stroke and hemorrhagic stroke 13. Active period of infective endocarditis or other active infection 14. Have existing untreated conduction system diseases that require pacemaker implantation 15. Those who have participated in clinical trials of other drugs or medical devices before being selected and have not yet reached the time limit of the main study endpoint 16. Other conditions that are not suitable for interventional aortic valve treatment as assessed by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Immediate device success rate ;Post-operative all-cause mortality (all-cause deaths include cardiac and non-cardiac deaths);Incidence of postoperative major cardiovascular and cerebrovascular events (MACCE) (MACCE includes death, stroke, myocardial infarction, reoperation, arrhythmia, and conduction block); | — |
Countries
China
Contacts
Public ContactLi yan
The Second Affiliated Hospital of Air Force Medical University
Outcome results
None listed