Aortic stenosis
Conditions
Interventions
case series:Nil
Sponsors
General Hospital of Norther Theater Command
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Severe aortic stenosis is defined as follows: a) Symptomatic patients: - The PG mean measured by echocardiography was >=40mm Hg; - or Peak Velocity >= 4.0m /s; - or EOA = 5.0 m/s or PG mean measured by echocardiography >= 60mm Hg; - or EOA = 4.0m /s or PG mean measured by echocardiography >= 40mm Hg, and limited exercise tolerance test, abnormal blood pressure response or arrhythmia; - or EOA = 4.0m /s or PG mean measured by echocardiography >= 40mm Hg, and LVEF< 50%.
Exclusion criteria
Exclusion criteria: 1. Contraindications to any bioprosthetic valve implantation; 2. Any known allergies or contraindications; - Aspirin or heparin and bivalirudin; - Ticlopidine and clopidogrel; - Nickel-titanium alloy; - Contrast agent; 3. The patient is currently participating in a drug or device study; 4. The patient is pregnant or lactating; 5. Aortic ring diameter 32mm; 6. Diameter of the approach vessel < 5.0mm; 7. The investigator considers the patient unsuitable to participate in the study or to complete the protocol follow-up.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of all-cause mortality 12 months after surgery; | — |
Secondary
| Measure | Time frame |
|---|---|
| Combined incidence of death, emergency surgery, severe stroke, life-threatening bleeding, severe vascular complications, and acute renal failure (within 30 days after surgery).;Permanent pacemaker implantation rate within 30 days.;All strokes (disabled or not disabled) at 12 months and 2, 3, 4, and 5 years.; the incidence of life-threatening bleeding at 12 months and at 2, 3, 4, and 5 years.;Resurgery due to prosthetic valve dysfunction within 12 months and 2, 3, 4 and 5 yearsPreexisting incidence.;Readmission for symptoms and signs of aortic valve disease within 12 months and 2, 3, 4, and 5 years; | — |
Countries
China
Contacts
Public ContactYuzhe Niu
Venus Medtech (Hangzhou) Inc.
Outcome results
None listed