Aortic (valve) stenosis
Conditions
Interventions
Intervention / Experimental
Procedure: TAVI-Labcor Optimum Aortic Valve Implant.
Total time of follow-up of each participant will be 12 months after the implantation of the Aortic Valve.
Interventions
Procedure/surgery
Sponsors
Labcor Laboratórios Ltda
Labcor Laboratórios Ltda
Eligibility
Age
70 Years to No maximum
Inclusion criteria
Inclusion criteria: Individual with aortic stenosis presenting the following echocardiographic criteria: Mean gradient greater than 40 mmHg or jet velocity greater than 4.0 m / s or aortic valve area less than 0.8 cm2 (or indexed aortic valve area less than 0.5 cm2 / m2); Symptomatic symptom due to valvular stenosis, demonstrated in NYHA II Functional Classification; STS greater than 8; Male or female; From any demographic area; Age 70 years; Coexisting predictive conditions of 50% probability of death within 30 days after surgery or "irreversible serious condition" evaluated by at least 2 investigators; The participant who presents risk of death or irreversible morbidity in conventional valve replacement surgery and probability of success exceeding 50% in transcatheter surgery should be evaluated for the medical or anatomical factors that led to this conclusion; The participant or legal representative must be informed about the nature of the study, he / she must agree to participate and sign the consent form; The participant must be willing to participate in this Protocol of Clinical Investigation, as well as, to allow post-implant follow-up.
Exclusion criteria
Exclusion criteria: Participants unable to comply with the Clinical Investigation Protocol; Evidence of acute myocardial infarction, 1 month before surgery (defined as myocardial infarction with Q wave, or without Q wave with elevation greater than or equal to twice the dosage of creatine kinase in the presence of elevation of CK-MB and / or elevation of troponin level - WHO definition; Congenital unicuspid or bicuspid aortic valve, or not calcified; Mixed aortic valve disease - stenosis and aortic regurgitation, with predominant aortic regurgitation greater than 3+; Any cardiac invasive therapeutic procedure performed within 30 days prior to the procedure or 6 months if the procedure performed was coronary stent implantation with drug elution; Previous existence of cardiac valvular prosthesis in any position, prosthetic ring, severe calcification of the mitral annulus, or severe mitral regurgitation greater than 3+; Blood dyscrasia, defined as leukopenia - WBC less than 3000 mm3, acute anemia Hb less than 9 mg%, thrombocytopenia - platelet count less than 50,000 cells / mm³, history of hemorrhagic diathesis or coagulopathy; Untreated coronary disease, requiring revascularization; Hemodynamic instability, requiring inotropic therapy or mechanical devices for hemodynamic support; Need for emergency surgery for any reason; Hypertrophic cardiomyopathy with or without obstruction; Severe ventricular dysfunction with left ventricular ejection fraction <20%; Echocardiographic evidence of intracardiac mass, thrombus or vegetation; Active peptic ulcer, or upper gastrointestinal bleeding within 3 months before Procedure; Known hypersensitivity or contraindication to aspirin, heparin, ticlopidine, or clopidogrel, or contrast sensitivity, which may not be adequately pre-medicated; Native aortic annulus size less than 21 mm or greater than 23 mm, determined by the surgeon using CT and or echocardiogram; Stroke or recent transient ischemic attack past 6 months; Renal insufficiency - creatinine greater than 3.0 mg / dL and end-stage renal disease requiring chronic dialysis; Life expectancy less than 12 months due to non-cardiac comorbidities; Significant disease of the abdominal or thoracic aorta, including aneurysm - defined as maximal luminal diameter 5 cm, severe tortuosity, atheroma in the aortic arch - especially if greater than 5 mm, protruding or ulcerated, narrowing of the abdominal aorta - especially if there is calcification and irregular surface , or severe "unfolding" and tortuosity of the thoracic aorta; Features of the iliofemoral vessel that prevents the safe placement of the catheter, such as severe calcification, severe tortuosity or vessel diameter less than 7 mm to 22F; Currently participating in the clinical investigation of another medical device; Active bacterial endocarditis or other active infections; Native aortic valve leaflet, near the coronary ostia, extensively calcified.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Expected outcome 1: Device success. Clinical evaluation data and laboratory and complementary tests to be performed before implantation and at 30, 90, 180 and 360 days after implantation.;Expected outcome 2: Combined outcome security. Clinical evaluation data and laboratory and complementary tests to be performed before implantation and at 30, 90, 180 and 360 days after implantation.;Expected outcome 3: Efficacy of combined outcome. Clinical evaluation data and laboratory and complementary tests to be performed before implantation and at 30, 90, 180 and 360 days after implantation. | — |
Secondary
| Measure | Time frame |
|---|---|
| Expected outcome 4: Incidence of mortality, all causes and cardiovascular. Clinical evaluation and follow-up data to be performed before implantation and at 30, 90, 180 and 360 days after implantation.;Expected outcome 5: Incidence of stroke, major or disabling. Clinical evaluation data and laboratory and complementary tests to be performed before implantation and at 30, 90, 180 and 360 days after implantation.;Expected outcome 6: Myocardial infarction, peri-processual and spontaneous. Clinical evaluation data and laboratory and complementary tests to be performed before implantation and at 30, 90, 180 and 360 days after implantation.;Expected outcome 7: Incidence of minor stroke. Clinical evaluation data and laboratory and complementary tests to be performed before implantation and at 30, 90, 180 and 360 days after implantation.;Expected outcome 8: Major bleeding, disabling or life-threatening. Clinical evaluation data and laboratory and complementary tests to be performed before implantation and at 30, 90, 180 and 360 days after implantation.;Expected outcome 9: Acute kidney injury - Modified RIFLE classification 2 and 3, including renal transplantation. Clinical evaluation data and laboratory and complementary tests to be performed before implantation and at 30, 90, 180 and 360 days after implantation.;Expected outcome 10: Major vascular complications. Echocardiography evaluations to be performed before implantation and at 30, 90, 180 and 360 days after implantation.;Expected outcome 11: Valve prosthesis performance - echocardiographic evaluations (stenosis and regurgitation of moderate or severe valvular prosthesis, with special reference to paravalvular regurgitation, thrombosis of valve prosthesis, endocarditis of valve prosthesis). Echocardiography evaluations to be performed before implantation and at 30, 90, 180 and 360 days after implantation.;Expected outcome 12: Complications associated with the valve prosthesis, such as conduction disorders and cardiac | — |
Countries
Brazil
Contacts
Public ContactIvan Casagrande
Labcor Laboratórios Ltda
Outcome results
None listed