Transfemoral Implant of Inovare® Transcatheter Valve

This is an interventional treatment trial for Aortic Valve Stenosis focused on measuring TAVI, TAVR, Transfemoral, Transcatheter Valve Read More

Inclusion Criteria:

• Calcified degenerative aortic stenosis with valve area < 1.0 cm2 (or valve area index < 0.6 cm2/m2) and mean transvalvular gradient > 40 mmHg or aortic jet velocity > 4 m/s by echocardiogram.

• Multidisciplinary evaluation by the "Heart Team", composed of a cardiovascular surgeon, clinical cardiologist and hemodynamicist, which concludes that the patient has:

  • High surgical risk for aortic valve replacement, typically with an STS score of ≥ 8% (or logistic EuroSCORE ≥ 20%) or intermediate risk (STS of ≥ 3% and < 8%);
  • Presence of porcelain aorta or hostile chest, as well as global clinical condition and comorbidities not fully addressed by the score STS
  • Presence of extreme frailty (5-meter walk test [5MWT], grip strength, activities of daily living (ADL), and albumin laboratory exam);
  • Considerable chance of clinical benefit with the transcatheter procedure.
• Heart failure symptoms NYHA functional ≥ II.
• Aortic valve annulus with a mean diameter between 17.3 and 28.6 mm, documented by imaging method, suitable for positioning and accommodation of the Inovare® prosthesis, according to the judgment of an experienced hemodynamicist.
• Height of coronary ostia > 10 mm or presence of a coronary graft that prevents the occurrence of acute myocardial ischemia due to coronary occlusion after valve release.
• Femoral arterial access route considered adequate for the progression of the vascular introducer and prosthesis-balloon system, typically evaluated through multi-imaging methods that include, for example, conventional angiography and computed tomography.
• Patient has provided written informed consent to participate in the trial.

Exclusion Criteria:

Clinic

• Hemodynamic instability requiring vasoactive drugs or circulatory support;
• Valve procedure with clinical need to be performed in a time of urgency or emergency (non-elective);
• Left ventricular ejection fraction < 30%;
• Chronic renal failure on dialysis or with serum creatinine levels > 3.0 mg/dL (265 µmol/L);
• Acute renal failure with serum creatinine that has not yet returned to baseline levels;
• Clinical or biological signs of infection with systemic repercussions;
• Endocarditis < 12 months;
• Coronary artery disease requiring elective revascularization during or after the valve procedure;
• Evidence of myocardial infarction in an interval of less than one month;
• Recent stroke or transient ischemic attack (within the last 6 months);
• Hypersensitivity or contraindication to the administration of heparin, ticlopidine or clopidogrel or to radiopaque contrast;
• Anemia (hemoglobin < 10 g/dl), thrombocytopenia (< 100,000 cells/mm3) or hyperthrombocytosis (> 700,000 cells/mm3);
• Need for chronic anticoagulation for other causes;
• Active peptic disease, gastrointestinal bleeding < 3 months, or previously diagnosed bleeding diathesis;
• Life expectancy less than 12 months due to non-cardiac disease or other comorbidities.

Anatomical/morphological

• Valve ring diameter less than or equal to 17.2 mm or greater than or equal to 28.7 mm;
• Iliofemoral access route, with extreme tortuosity or calcification or reduced luminal diameter (typically < 7 mm), which prevents safe progression of the arterial introducer and delivery system with the prosthesis, according to the judgment of the responsible physician;
• Presence of sessile and unstable atheromas in the ascending aorta and/or aortic arch detected by imaging methods;
• Obstructive hypertrophic cardiomyopathy or severe left ventricular outflow tract obstruction, with no possibility of balloon dilation;
• Previous aortic or mitral valve procedure (surgical or by catheter, excluding aortic balloon valvuloplasty);
• Moderate or severe aortic, mitral or tricuspid regurgitation;
• Non-calcified native valve;
• Evidence of an intracardiac mass (tumor, thrombus, or vegetation).