Safety and efficacy of the Inovare® Transcatheter Valve Implantation via femoral

Not Applicable

Recruiting

• Conditions: Aortic Valve Stenosis

• Registration Number: RBR-744myhk
• 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: 2023-02-09
• Last Update Posted: 29 May 2023
• Study Completion: 2028-12-30

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 presence of porcelain aorta or hostile chest, as well as global clinical condition and comorbidities not fully addressed by the STS risk score, or extreme fragility, or considerable chance of clinical benefit from the transcatheter procedure; Symptoms of heart failure in NYHA functional class equal to or greater than II 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 greater than 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

Clinicos: Hemodynamic instability requiring vasoactive drugs or circulatory support; procedure with a clinical need to be carried out in an emergency or time of urgency (not elective); a left-side ventrical fracture that is less than 30%; Diabetic renal insufficiency; severe renal insufficiency with persistently elevated levels of creatinine; clinical or biological signs of infection with widespread effects; Endocardite at intervals no greater than 12 months; a coronary disease requiring elective revascularization during or after the valve procedure; evidence of myocardial infarction within a month or less; cerebral vascular accident or recent transient ischaemic attack (within the last six months); sensitivity to or contraindication to the administration of heparin, ticlopidine, clopidogrel, or radiopaco contrast agent; Anemia, hyperthyroidism, or plaquetopenia; a critical need for anticoagulation due to other causes; active peptic disease, gastrointestinal bleeding within three months or previously diagnosed hemorrhagic days; Expectation of life of less than 12 months due to non-cardiac disease or other disorders.
Anatômicos/morfológicos: Diameter of anel valve greater than or equal to 28,7 mm, or less than or equal to 17,2 mm; ilaco-femoral access route with tortuosity, severe calcification, or reduced luminal diameter that prevents the safe advancement of the introducer arterial and prate system; detection of the presence of stable and significant atheromas in the ascending aorta and/or aortic arch using imaging methods; miocardiopathy with obstructed or severe obstruction of the left ventricle's exit pathway without possibility of balloon dilatation; Procedure to previously valve the aorta or the mitral (by surgery or by catheter, excluding aorta valvoplastia by balo); moderate or accentuated aortic, mitral, or tricuspid insufficiency; native valve not calcified; Evidence of mass intracardiac bleeding.

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 it exceeds 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 Outcome Measures

Name	Time	Method
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.