About this trial
The purpose of this study was to observe the safety and effectiveness of transcatheter aortic valve replacement in patients with aortic valve stenosis in a real-world clinical practice environment.
Eligibility criteria
Qualifiers
The mean differential pressure measured by echocardiography ≥ 40mm Hg
Or peak aortic ejection ≥ 4.0 m / S
Or aortic valve area ≤ 1.0cm ²( Or AVA index ≤ 0.6 cm2 / m2)
Severe aortic stenosis and aortic valve area ≤ 1.0cm ²( 6 cm2 / m2) with aortic ejection peak value ≥ 5.0 M / s or mean pressure difference measured by --echocardiography ≥ 60 mm Hg;
Disqualifiers
Contraindications to any artificial biological valve implantation;
Any known allergies or contraindications;
Aspirin or heparin and bivalirudin;
Tigrelol and clopidogrel;
Trial design
Treatments tested in this trial
- All aortic valve products on the market
Treatment groups
Locations
Sponsors and collaborators
CCRF Inc., Beijing, China
Lead sponsor
Hangzhou Qiming Medical Instrument Co., Ltd
Collaborator