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.
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;
Contraindications to any artificial biological valve implantation;
Any known allergies or contraindications;
Aspirin or heparin and bivalirudin;
Tigrelol and clopidogrel;
Sequential
All aortic valve products on the market
Other intervention1. Subjects with severe aortic valve stenosis 2. Subjects who plan (or have) to use the transcatheter aortic valve replacement system for percutaneous aortic valve replacement 3. The patients agreed to join the study, voluntarily signed the informed consent and completed the follow-up; 4. Be able to contact the subjects or their legal guardians / relatives; 5. The medical record records the subjects who have died and can't get any contact information of the subjects（ (for dead cases only) Sign the informed consent form, then check the inclusion and exclusion criteria, register after meeting the criteria, obtain the registration number, perform aortic valve replacement surgery, follow-up 24 hours, discharge, 30 days, 1 year, 2 years, 3 years, 4 years and 5 years after operation according to the test requirements, and carry out relevant follow-up according to the scheme requirements to collect data
Primary end point: the incidence of all-cause death 12 months after operation
After subjects completed aortic valve replacement surgery, whether prospectively or retrospectively, all-cause mortality at 12 months after operation was collected according to the time node of subjects' enrollment
The compound incidence of death, surgery, severe stroke, life-threatening bleeding, serious vascular complications and acute renal failure (within 30 days after operation);
The compound incidence of death, surgery, severe stroke, life-threatening bleeding, serious vascular complications and acute renal failure (within 30 days after operation);
The implantation rate of permanent pacemaker within 30 days;
The implantation rate of permanent pacemaker within 30 days;
All stroke (disabled or not disabled) within 12 months and 2, 3, 4 and 5 years
All stroke (disabled or not disabled) within 12 months and 2, 3, 4 and 5 years;
the incidence of life-threatening bleeding within 12 months and 2, 3, 4 and 5 years;
the incidence of life-threatening bleeding within 12 months and 2, 3, 4 and 5 years;
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CCRF Inc., Beijing, China
Lead sponsor
Hangzhou Qiming Medical Instrument Co., Ltd
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
