Severe aortic valve stenosis
Conditions
Interventions
Trial group:Treating severe aortic stenosis with the Peijia Medical's transcatheter aortic valve system (TaurusOne/TaurusElite/TaurusMax)
Sponsors
The First Affiliated Hospital of Soochow University
Eligibility
Sex/Gender
All
Age
60 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >= 60 years old; 2. Voluntary participants who have signed the informed consent form and can cooperate throughout the entire research process; 3. Patients with severe AS who meet the indications for TAVR (absolute indications/relative indications): Echocardiography shows that the transaortic valve blood flow velocity is >= 4.0 m/s, or the transaortic valve pressure difference is >= 40 mmHg (1 mmHg = 0.133 kPa), or the aortic valve area is < 1.0 cm^2, or the effective aortic valve area index is < 0.5 cm^2/m^2; Patients with low flow rate and low pressure difference who are evaluated and diagnosed as severe AS through dobutamine loading test, Doppler ultrasound assessment or other imaging methods; 4. Patients who plan to be treated with the Peijia Medical's transcatheter aortic valve system (TaurusOne®/TaurusElite®/TaurusMax®).
Exclusion criteria
Exclusion criteria: 1. The ostia of the left and right coronary arteries originate from the junction area or from the common opening of the left and right coronary arteries; 2. After previous coronary artery bypass surgery; 3. Coronary artery stenosis (with/without PCI); 4. The peripheral arteries are in poor condition, making it impossible to perform transfemoral TAVR; 5. Intervention/Surgical Biological Valve Damage - Valve-in-Valve Replacement; 6. The echocardiogram indicates left heart system thrombus, intracardiac masses or deposits; 7. Left ventricular outflow tract obstruction; 8. Mitral regurgitation or tricuspid regurgitation is > moderate; 9. Within 180 days before the surgery, there was endocarditis or other active infection (not completely cured); 10. Severe pulmonary hypertension (pulmonary artery systolic pressure > 80 mmHg); 11. Through clinical and ultrasound comprehensive assessment, there is severe right heart dysfunction; 12. Left ventricular ejection fraction is severely reduced (LVEF 70%); 18. Severe hematological abnormalities, including leukopenia, thrombocytopenia, anemia, coagulation dysfunction; 19. Within 90 days before the surgery, there was gastrointestinal bleeding; 20. Known to have severe allergy to contrast agents, aspirin, heparin, ticlopidine-like drugs, nickel-titanium memory alloy or bovine products; 21. The expected lifespan after correcting AS is less than 12 months; 22. The subject has been enrolled in another ongoing clinical study that requires main endpoint follow-up (Note: Subjects in the long-term monitoring stage of another study are eligible to join this study); 23. The investigator believes that the subject has other medical, social or psychological conditions that prevent providing proper informed consent; 24. The subject is unable to comply with the follow-up requirements of this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The rate of achieving alignment of the apposition margins after TAVR (excluding Type 0 BAV cases);The rate of coronary alignment achieved after TAVR surgery; | — |
Secondary
| Measure | Time frame |
|---|---|
| The equipment was successfully operated.;Technical success; | — |
Countries
China
Contacts
Public ContactJiang Tingbo
The First Affiliated Hospital of Soochow University
Outcome results
None listed