Resumen

Este es un estudio prospectivo, de un solo brazo y multicéntrico en una cohorte de hasta 267 pacientes (hasta 100 casos de entrenamiento y 167 pacientes implantados según el protocolo) con pacientes sintomáticos con estenosis aórtica grave que serán seguidos durante hasta 5 años.

Descripción detallada

El propósito de este ensayo es determinar la seguridad y eficacia del sistema Vienna Aortic Valve SE, una nueva válvula cardíaca transcatéter autoexpandible, en pacientes con estenosis aórtica grave sintomática (SSAS). Este es un estudio prospectivo, de un solo brazo y multicéntrico en una cohorte en expansión de pacientes sintomáticos con estenosis aórtica grave, tras el estudio de factibilidad FIH. La investigación clínica comprende 11 visitas (V1 a V11). Después del implante del DMI en la visita 2, se realizará la evaluación de seguridad y eficacia del dispositivo a los 30 días (V4), 3 meses (V5), 6 meses (V6), 1 año (V7) y anualmente hasta 5 años posimplante (V8 a V11). En resumen, la investigación clínica para el paciente individual finalizará a los 5 años con una evaluación clínica completa. Los criterios de valoración primarios del estudio para seguridad y eficacia se alcanzarán en el punto de seguimiento de los 30 días. El ensayo clínico se completará cuando los 267 pacientes que no se hayan retirado prematuramente hayan completado su visita de seguimiento de 5 años con todas las evaluaciones especificadas.

Elegibilidad

Edad mínima: 65 YearsSexo: ALL

Criterios de inclusión

Male or Female
Age ≥ 65 years at time of consent
Women of non-childbearing potential
Severe degenerative calcific native aortic valve stenosis with the following criteria assessed either by resting or dobutamine stress TTE:
Aortic valve area (AVA) \< 1.0 cm2 or AVA index ≤ 0.6 cm2/m2 and
Jet velocity \> 4.0 m/s or mean gradient \> 40 mmHg
Symptomatic aortic stenosis (AS), defined as a history of at least one of the following:
Dyspnea that qualifies at NYHA class II or greater
Angina pectoris
Cardiac syncope
Subject is considered at intermediate or high risk for surgical valve replacement based on at least one of the following:
EuroSCORE II ≥ 4% along with assessment of frailty, major organ system dysfunction, and procedure-specific impediments, in accordance with scientific guidelines
Agreement by the Heart Team that subject is at moderate to high operative risk of serious morbidity or mortality with surgical valve replacement.
The local Heart Team deems the patient to be eligible for transfemoral TAVI.
Perimeter-based aortic annulus diameter between ≥ 18 and ≤ 29 mm measured by computed tomography (CT) analyzed by a core lab.
Adequate iliofemoral access with either:
At least one side with minimum vessel diameter ≥ 6.0 mm and acceptable level of vessel calcification and tortuosity for safe placement of the introducer sheath, as analyzed by a core lab, OR
At least one side with minimum vessel diameter ≥ 5.5 and no significant calcification or severe tortuosity for safe placement of the introducer sheath, as analyzed by a core lab.
Patient (or legal representative) understands the study requirements and the treatment procedures and provides written informed consent.
The patient and the treating physician agree that the patient will return for all required post-procedure follow-up visits.

Criterios de exclusión

Cardiovascular System:
Patient has a congenital unicuspid or bicuspid aortic valve or non-calcified valves.
Evidence of an acute myocardial infarction (MI) ≤ 30 days prior to screening or IMD implantation (defined as Q-wave MI or non-Q-wave MI with total CK elevation ≥ twice normal in the presence of CK-MB elevation and/or troponin elevation).
Patient has had a cerebrovascular stroke or TIA within the past 90 days implantation prior to screening or valve implantation.
Patient has a hypertrophic obstructive cardiomyopathy.
History of any therapeutic invasive cardiac procedure (including balloon aortic valvuloplasty) within 30 days prior to screening or IMD implantation (except for pacemaker implantation which is allowed).
Untreated clinically significant coronary artery disease requiring revascularization at the screening visit.
Severe left ventricular dysfunction with left ventricular ejection fraction (LVEF) \< 20% by echocardiography, contrast ventriculography, or radionuclide ventriculography.
Patient with cardiogenic shock manifested by low cardiac output and hemodynamic instability and vasopressor dependence, or mechanical hemodynamic support
Patients with clinically significant conduction abnormalities (clinically significant sinus bradycardia, sinus block or pauses, clinically significant atrioventricular (AV)-block \>I) at screening and at time of IMD implantation.
Patient has severe peripheral vascular disease:
including aortic aneurysm defined as maximal luminal diameter \> 5 cm or with documented presence of thrombus, marked tortuosity, narrowing of the abdominal aorta, severe unfolding of the thoracic aorta or thick \[\> 5 mm\], protruding or ulcerated atheroma in the aortic arch) or
symptomatic carotid or vertebral disease or successful treatment of carotid stenosis within 30 days prior to screening or IMD implantation.
Patient with iliofemoral vessel characteristics that would preclude safe passage of the introducer (both sides), as analyzed by a core lab:
severe calcification,
severe tortuosity (\> two 90-degree bends),
diameter \< 6 mm, in patients with acceptable levels of calcification and acceptable levels of tortuosity
diameter \< 5.5, in patients with no calcification and no significant tortuosity, OR
subject has had an aorto-femoral bypass
Patient with active bacterial endocarditis within 6 months prior to screening or IMD implantation.
Patient has (echocardiographic/ CT and/or MRI) evidence of intra-cardiac mass, thrombus or vegetation.
Patient has a pre-existing prosthetic heart valve in any position (Note: mitral ring is not an exclusion).
Patient has severe mitral regurgitation, severe aortic regurgitation or severe tricuspid regurgitation, moderate or severe mitral stenosis.
Patient has a need for emergency surgery for any reason at time of screening or IMD implantation.
General:
Any condition considered a contraindication for placement of a bioprosthetic valve (e.g. patient with contraindication to oral antiplatelet therapy)
Patient with renal insufficiency (eGFR \< 30 ml/min per the Cockcroft-Gault formula) and/ or renal replacement therapy and/ or has serum creatinine level \> 3.0 mg/dL or 265 µmol/L replacement therapy at the time of screening
Patient with significant pulmonary disease (FEV1 \< 30%) or currently on home oxygen
Severe pulmonary hypertension (e.g., pulmonary artery systolic pressure ≥ 60 mmHg)
Patients with evidence of an active systemic infection or sepsis.
Patient has a known hypersensitivity or contraindication to contrast media, bovine tissue, nitinol (titanium or nickel), contraindication to oral antiplatelet therapy (aspirin, ticlopidine or clopidogrel) or heparin.
Patient has a haemoglobin \< 9 g/dL, platelet count \< 50,000 cells/mm3 or \> 700.000 cells/mm3, or white blood cell count \< 1.000 cells/mm3, history of bleeding diathesis or coagulopathy
Patient has peptic ulcer disease or history of gastrointestinal bleeding within the 3 months prior to screening or IMD implantation.
Patient refuses blood transfusions.
Patient has a life expectancy of less than 12 months due to non-cardiac, co-morbid conditions based on the assessment of the investigator at the time of enrolment (i.e. the time of informed consent).
Patient is pregnant or breast feeding.
Severe dementia (resulting in either inability to provide informed consent for the study/procedure, prevents independent lifestyle outside of a chronic care facility, or will fundamentally complicate rehabilitation from the procedure or compliance with follow-up visits).
Other medical, social, or psychological conditions that in the opinion of the Investigator precludes the patient from appropriate consent or adherence to the protocol required follow-up exams.
Patient is currently participating in another investigational drug or device study that has not reached its primary endpoint (excluding observational studies).

Ubicaciones

Hospital Privado Sur (FUMEBA)

Bahía Blanca, Argentina

Alejandro Alvarez Iorio, MD · alexalv1970@gmail.com

NOT_YET_RECRUITING

Fundación Favaloro

Buenos Aires, Argentina

Oscar Mendiz, MD · omendiz@ffavaloro.org

NOT_YET_RECRUITING

Hospital Italiano De Buenos Aires

Buenos Aires, Argentina

Carla Agatiello, MD · carla.agatiello@hospitalitaliano.org.ar

NOT_YET_RECRUITING

Estudio de factibilidad/pivotal en dos etapas de primera administración en humanos (FIH) del sistema Vienna Aortic Valve SE

Resumen

Descripción detallada

Elegibilidad

Criterios de inclusión

Criterios de exclusión

Intervenciones

Vienna Aortic Valve SE System

Ubicaciones

Hospital Privado Sur (FUMEBA)

Fundación Favaloro

Hospital Italiano De Buenos Aires

Patrocinadores

Contactos

Katharina Kiss, Dr

Monica Tocchi, MD, PhD