aortic valve stenosis
Conditions
Interventions
The study is prospective, single-arm, with no control group. Divided into two phases: (Phase 1 - Feasebility and Phase 2 - Pivotal). All 60 patients (20 from Phase 1 and 40 from Phase 2), after being
Sponsors
Instituto do Coração do Hospital das Clínicas da Faculdade de Medicina da USP
Instituto Dante Pazzanese de Cardiologia
Hospital São Paulo – Escola Paulista de Medicina (Unifesp)
Eligibility
Age
18 Years to 90 Years
Inclusion criteria
Inclusion criteria: Patients with significant calcified degenerative native aortic valve stenosis; Multidisciplinary evaluation by the "Heart Team" that concludes that the patient has a high surgical risk for aortic valve replacement or the presence of extreme fragility or the presence of comorbidities or aorta in porcelain or hostile chest; Symptoms of heart failure in NYHA functional class = II; Aortic valve ring with an average diameter between 17.3 and 28.6 mm, documented by imaging method, suitable for positioning and accommodating the Inovare® prosthesis; Coronary ostia height> 10 mm or presence of coronary graft that prevents the occurrence of acute myocardial ischemia due to coronary occlusion after the valve is released; Arterial femoral access route considered adequate for the progression of the vascular introducer and prosthesis-balloon system; Signed Free and Informed Consent Form.
Exclusion criteria
Exclusion criteria: Clinicals: Hemodynamic instability with the need for vasoactive drugs or circulatory support; Valve procedure with clinical need to be performed in times of urgency or emergency (non-elective); Left ventricular ejection fraction <30%; Chronic dialysis renal failure; 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 disease requiring elective revascularization during or after the valve procedure; Evidence of myocardial infarction in less than one month; Stroke or recent transient ischemic attack (in the last 6 months); Hypersensitivity or contraindication to the administration of heparin, ticlopidine or clopidogrel or to the radiopaque contrast medium; Anemia, thrombocytopenia or hyperthrombocytosis; Need for chronic anticoagulation for other causes; Active peptic disease, gastrointestinal bleeding <3 months or previously diagnosed hemorrhagic diasteses; Life expectancy less than 12 months due to non-heart disease or other comorbidities. Anatomical / morphological: Valve ring diameter less than or equal to 17.2 mm or greater or equal to 28.7 mm; Iliac-femoral access route, with extreme tortuosity or calcification or reduced luminal diameter, which prevents the safe progression of the arterial introducer and delivery system with the prosthesis; Presence of sessile and unstable atheroma in the ascending aorta and / or aortic arch detected by imaging methods; Obstructive hypertrophic cardiomyopathy or severe obstruction of the left ventricular outflow tract, with no possibility of balloon dilation; Previous aortic or mitral valve procedure (surgical or by catheter, excluding balloon aortic valvuloplasty); Moderate or severe aortic, mitral or tricuspid insufficiency; Native valve not calcified; Evidence of intracardiac mass.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Success of the device considered as the non-occurrence of death related to the procedure, making it possible to adequately implant a single prosthesis, with a mean aortic transvalvular gradient less than 20 mmHg or peak speed less than 3 m / s, and with mild aortic regurgitation; Deaths from any cause within the first 30 days of the procedure or during the hospital stay, if this has exceeded 30 days, will be considered procedure-related deaths. Mortality will be defined immediately after the procedure, when death occurs within the first 72 hours. | — |
Secondary
| Measure | Time frame |
|---|---|
| Device success (30 days or more): No mortality; Proper positioning of a single valve; Proper functioning (mean gradient <20 mmHg and moderate regurgitation). Incidence of serious adverse events (30 days or more): Global mortality; Coronary obstruction requiring percutaneous intervention; Stroke; Grade 2-3 acute kidney injury requiring dialysis technique; Life-threatening bleeding (or sequelae) or bleeding from a critical organ or hypovolemic shock with vasopressors or requiring surgery or more transfusions; Major vascular complication; Reintervention due to valve dysfunction; Acute myocardial infarction; Need for permanent pacemaker implantation. Effectiveness of the procedure (30 days or more): Mortality from all causes; Stroke. Rehospitalization due to treatment failure: due to valve symptoms or heart failure; NYHA Class III or IV; Dysfunction of the valve prosthesis by a stenosed valve and / or moderate or severe aortic regurgitation. | — |
Countries
Brazil
Contacts
Public ContactGlaucia Frazzato
Braile Biomédica
Outcome results
None listed