Evaluation of the heart valve (Optimum TAVI-Labcor)

Not Applicable

Recruiting

• Conditions: Aortic (valve) stenosis; Aortic Valve Stenosis; Rheumatic aortic stenosis; Aged; I35.0; C14.280.484.150; I06.0; M01.060.116.100

• Registration Number: RBR-76dhsn
• Lead Sponsor: abcor Laboratórios Ltda

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-02-19
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: Not specified

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

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.

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.