Calcific Severe Aortic Stenosis
Conditions
Interventions
Experimental group:All enrolled subjects will receive pre-dilation with the SmartWave Valvuloplasty Lithotripsy System before TAVR using a self-expanding valve system.
Sponsors
The Second Affiliated Hospital of Zhejiang University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >= 18 years old, gender not restricted; 2. Patients with calcified severe aortic stenosis who meet the indications for TAVR; 3. Those whose anatomical structure has been evaluated by the cardiac team and is suitable for the SmartWave shock wave valve treatment system; 4. Voluntary participants in this trial and who have signed the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Those with bacteremia or toxemia; 2. Those with active infectious endocarditis; 3. Those with echocardiographic findings of intracardiac masses, left ventricular or left atrial thrombi, or vegetations before surgery; 4. Those with non-calcified aortic stenosis (such as simple rheumatic aortic valve disease, etc.); 5. Those with known other valvular diseases requiring surgical intervention; 6. Those known to require emergency surgery for any reason; 7. Those with hemodynamic instability due to cardiogenic shock, or requiring positive inotropic drugs, mechanical ventilation, or mechanical heart assistance; 8. Those with severe left ventricular dysfunction (defined as left ventricular ejection fraction LVEF < 20%); 9. Those with severe obstructive hypertrophic cardiomyopathy; 10. Those who have experienced gastrointestinal bleeding or other clinically significant bleeding requiring hospitalization or blood transfusion within 3 months before surgery; 11. Subjects with severe coagulation disorders; 12. Those who have experienced acute myocardial infarction within 30 days before surgery; 13. Those who have experienced clinically diagnosed stroke within 30 days before surgery; 14. Those who have previously received aortic valve graft (mechanical or biological) implantation; 15. Those with severe renal insufficiency or undergoing dialysis treatment; 16. Those who are contraindicated or allergic to antiplatelet, anticoagulant drugs; 17. Those who are known to be allergic to contrast agents, aspirin, heparin, ticlopidine-like drugs, nickel-titanium memory alloys, or bovine products; 18. Pregnant or lactating female subjects; 19. Those who, after assessment by the investigator, are expected to have a life expectancy of less than 12 months; 20. Those who are participating in other clinical studies of drugs or devices; 21. Those who, after assessment by the investigator, are not suitable to participate in this trial for other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The rate of avoiding MACE (Major Adverse Cardiac Events) occurrence;Composite endpoints related to equipment and surgery; | — |
Secondary
| Measure | Time frame |
|---|---|
| Echocardiographic Parameters;Presence, number, and total volume of new cerebral lesions detected by DW-MRI prior to hospital discharge;Prosthetic Valve Morphological Endpoint;Functional Endpoint;Device Performance Evaluation;Safety Endpoints; | — |
Countries
China
Contacts
Public ContactJianan Wang
The Second Affiliated Hospital of Zhejiang University School of Medicine
Outcome results
None listed