Clinical trial of feasibility and verification of safety and efficacy of the transfemoral implant of the Inovare® valve

Not Applicable

Recruiting

• Conditions: aortic valve stenosis

• Registration Number: RBR-53r6n7
• Lead Sponsor: Instituto do Coração do Hospital das Clínicas da Faculdade de Medicina da USP

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-02-17
• Last Update Posted: 29 May 2023
• Study Completion: 2027-11-01

Recruitment & Eligibility

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

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

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.

Study & Design

• Study Type: Intervention
• Study Design: Not specified