Severe Aortic Stenosis
Conditions
Interventions
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
60 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >= 60 years; 2. Severe aortic stenosis (AS, grade 3+), defined as AVA= 4.0 m/s or MPG >=40 mmHg determined by echocardiography; 3. Patients deemed for cardiac intervention by a heart team; 4. American Society of Thoracic Surgeons (STS) score >=8% or Patients who are assessed to be not suitable for conventional surgical valve replacement; 5. The patients or their legal guardians agreed to participate and be followed up as specified and were able to provide written informed consent.
Exclusion criteria
Exclusion criteria: Co-morbidities 1. Previous mechanical or biological valve replacement and repair; 2. Untreated mitral, tricuspid or pulmonary valve diseases requiring procedural intervention; 3. Acute myocardial infact within 30 days; 4. Untreated clinically significant coronary artery disease requiring revascularization; 5. Stroke or TIA within 3 months, or Modified Rankin Scale >= 4 disability; 6. Estimated irreversible severe chronic kidney disease damage (eGFR<30 mL/min/1.73m^2); 7. Clinical significant disorders: Leukopenia (WBC < 3000 cell/mL), anemia (Hgb < 9 g/dL), thrombocytopenia (Plt< 50,000 cell/mL), or any known blood clotting disorder; Anatomic 1. LVEF < 20%; 2. Imaging shows signs of intracardiac mass, thrombus, or vegetation; 3. Inappropriate anatomy for femoral introduction and delivery of study device; 4. Native aortic valve geometry and size unfavorable for study device anchoring. General 1. Haemodynamics instability requiring inotropic support or intra-aortic balloon pump (IABP) or other hemodynamic support device, or any mechanical heart assistance; 2. Known hypersensitivity or contraindication to antiplatelet, antithrombotic medications, or any compotent of Venus-PowerX system (Nitinol, pig pericardium, PTFE, etc.) leading to be unable to undergo index procedure per physicians' judgment; 3. Life expectancy <= 1 year; 4. Active infection requiring antibiotic therapy including infective endocarditis; 5. Planned relevant concomitant procedure within 30 days post-index procedure; 6. Pregnant, breastfeeding or intend to become pregnant within 1 year; 7. Active peptic ulcer or history of upper gastrointestinal bleeding within 3 months; 8. According to the evaluation of the investigator or coordinating investigator, the patient was not suitable for participating in this clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| All-Cause Mortality;incidence of SAE;KCCQ-12 Score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Technical success(VARC-3) ;Device success (VARC-3);Acceptable valve function;Hospitalization due to heart failure;Acute myocardial infraction;disabling stroke ;non-disabling stroke;Cardiovascular and non-cardiovascular mortality;Implant a new PPM;Severe bleeding (VARC 3 =2 );Acute kidney injury (AKI Stage 2 and 3) or renal alternation therapy, renal replacement therapy (RRT) (hemodialysis, peritoneal dialysis and hemofiltration) ;Aortic valve re-intervention (surgical or transcatheter) ;Valve thrombosis;Structural valve deterioration ;Paravalvular leak (PVL) by echocardiogram;New York Heart Association (NYHA) classification;incidence of AE; | — |
Countries
China
Contacts
Public ContactChen Mao
West China Hospital of Sichuan University
Outcome results
None listed