Structural heart diseases
Conditions
Interventions
interventional group:transcatheter heart valve implantation
Sponsors
Department of Cardiology, West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 90 Years
Inclusion criteria
Inclusion criteria: 1) Male patients aged =18 years and =90 years old or female patients who are not pregnant or lactating; 2) Patients with the following types of valvular diseases 1. Aortic valve stenosis: pressure difference across the aortic valve = 40mmHg (1mmHg = 0.133kPa), or blood flow velocity across the aortic valve = 4m/s, or aortic valve orifice area 12 months; 5) Patients who are anatomically suitable for transcatheter artificial valve implantation surgery; 6) Patients who have been evaluated by two or more cardiovascular surgeons and are not suitable for routine surgery; or patients who refuse routine surgery after full communication with the surgeons and who are high-risk for routine surgery; 7) Patients who can understand the purpose of the trial, voluntarily participate and sign the informed consent form, and are willing to undergo relevant examinations and clinical follow-up.
Exclusion criteria
Exclusion criteria: 1) Congenital unileaflet aortic valve; 2) Any therapeutic cardiac operation (except PCI and pacemaker implantation) within 30 days; 3) The patient has blood system diseases or abnormalities that make surgical treatment inappropriate; 4) Severe untreated coronary artery stenosis requiring revascularization; 5) Patients who require emergency non-valvular surgery for any reason; 6) Patients with hypertrophic cardiomyopathy accompanied by left ventricular outflow tract obstruction; 7) Severe left ventricular dysfunction, left ventricular ejection fraction (LVEF) <20%; 8) Echocardiography suggests the presence of intracardiac masses, thrombi, or vegetations; 9) History of acute peptic ulcer or upper gastrointestinal bleeding within 3 months; 10) Those who are allergic or resistant to cobalt-chromium alloys, contrast agents and related components; 11) Patients who cannot receive anticoagulation or antiplatelet therapy; 12) Cerebrovascular accident within 3 months, excluding transient ischemic attack; 13) Severe vascular disease, resulting in inability to perform access operations; 14) Active stage of infective endocarditis or other active infections; 15) Severe neurological disease, unable to take care of oneself; 16) Those who have participated in other drug or medical device clinical trials before enrollment and have not yet reached the main study endpoint time limit; 17) The researcher judges that the patient has poor compliance and is unable to complete the study as required.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Immediate success rate;One year postoperative all-cause mortality rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| The incidence of major serious cardiovascular and cerebrovascular adverse events;All-Cause Mortality; | — |
Countries
china
Contacts
Public ContactChen Mao
West China Hospital, Sichuan University
Outcome results
None listed