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.
This study is a prospective / retrospective, multicenterstudy after listing. The researchers preliminarily confirmed that they could be enrolled in this study according to the diagnosis of the subjects' medical history. After fully informed, they signed the informed consent, and met the TAVR inclusion requirements (see the inclusion criteria for details). At the same time, they registered the subjects in multiple centers. After the start of the trial, the participants were enrolled in the study, All the subjects who met the inclusion criteria but did not meet the discharge criteria were registered in the central registration system. The patients were followed up for 30 days, 6 months and 12 months, and followed up by telephone for 2, 3, 4 and 5 years.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
320
1. 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
Time frame: 12 months after aortic valve replacement
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);
Time frame: Within 30 days after aortic valve replacement
The implantation rate of permanent pacemaker within 30 days;
The implantation rate of permanent pacemaker within 30 days;
Time frame: Within 30 days after aortic valve replacement
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;
Time frame: 12 months and within 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;
Time frame: 12 months and within 2, 3, 4 and 5 years
The incidence of reoperation due to dysfunction of prosthetic valve within 12 months and 2,3,4,5 years;
The incidence of reoperation due to dysfunction of prosthetic valve within 12 months and 2,3,4,5 years;
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Time frame: 12 months and within 2, 3, 4 and 5 years
The incidence of readmission due to symptoms and signs of aortic valve disease within 12 months and 2,3,4,5 years;
The incidence of readmission due to symptoms and signs of aortic valve disease within 12 months and 2,3,4,5 years;
Time frame: 12 months and within 2, 3, 4 and 5 years
The incidence of prosthetic valve dysfunction at 12 months (moderate or severe stenosis or reflux by ultrasonography);
The incidence of prosthetic valve dysfunction at 12 months (moderate or severe stenosis or reflux by ultrasonography);
Time frame: 12 months and within 2, 3, 4 and 5 years
The incidence of thrombus in clinical and subclinical prosthetic heart valves at 12 months;
The incidence of thrombus in clinical and subclinical prosthetic heart valves at 12 months;
Time frame: 12 months after aortic valve replacement