- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01651052
Clinical Trial of the Edwards Aortic Bioprosthesis, Model 11000
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Kraków, Polonia, 31-202
- Krakowski Szpital Specjalistyczny im. Jana Pawła II
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Warsaw, Polonia, 04-628
- Instytut Kardiologii im. Prymasa Tysiąclecia Stefana Kardynała Wyszyńskiego
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- 18 years or older
- Require replacement of aortic valve
- Signed informed consent
- Willing to return to study site for follow-up visits
Exclusion Criteria:
- Active endocarditis/myocarditis (< 3 months)
- Myocardial infarction (< 30 days)
- Renal insufficiency/ End-stage renal disease
- Life expectancy (< 1 year)
- Requires multiple valve replacement/repair
- Requiring emergent aortic valve surgery
- Pregnant or lactating
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: Aortic Bioprosthesis, Model 11000
Aortic valve replacement therapy
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Implant of an aortic valve, Model 11000
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Número de eventos adversos tempranos dividido por el número de sujetos (expresado como porcentaje)
Periodo de tiempo: Eventos ocurridos dentro de los 30 días del procedimiento
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Número de eventos adversos tempranos que ocurren dentro de los 30 días del procedimiento dividido por el número de sujetos inscritos multiplicado por 100
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Eventos ocurridos dentro de los 30 días del procedimiento
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Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage)
Periodo de tiempo: Events occurring >= 31 days and up through 5 years post-implant
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Number of late events divided by the total number of late patient years x 100.
Late patient years are calculated from 31 days post-implant to the date of the last contact (follow up or adverse event).
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Events occurring >= 31 days and up through 5 years post-implant
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Subject's Average Mean Gradient Measurements
Periodo de tiempo: Baseline through 5-Year (at each scheduled follow-up visit)
|
Mean gradient is the average flow of blood through the aortic valve measured in millimeters of mercury.
Gradients are evaluated by echocardiography over time.
Mean gradient values depend on the size and type of valve.
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Baseline through 5-Year (at each scheduled follow-up visit)
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Subject's Average Effective Orifice Area Measurements
Periodo de tiempo: Baseline through 5-Year (at each scheduled follow-up visit)
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Effective orifice area represents the cross-sectional area of the blood flow downstream of the aortic valve.
Effective orifice area is evaluated by echocardiography over time.
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Baseline through 5-Year (at each scheduled follow-up visit)
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Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline.
Periodo de tiempo: 3-6 Months and 1 through 5 Years compared to baseline
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The New York Heart Association (NYHA) functional classification system relates symptoms to everyday activities and the patient's quality of life. Class I. Patients with cardiac disease but without resulting limitation of physical activity. Class II. Patients with cardiac disease resulting in slight limitation of physical activity. They are comfortable at rest. Class III. Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Class IV. Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of heart failure or the anginal syndrome may be present even at rest. |
3-6 Months and 1 through 5 Years compared to baseline
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Subject's Average Score at Baseline and 1 Year on the Quality of Life Survey
Periodo de tiempo: Baseline and one year follow-up
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The Medical Outcomes Study Short-Form 12 (SF-12) contains two components - the Physical Component Summary (PCS) and the Mental Component Summary (MCS). The SF-12 Physical Component Summary questionnaire scale ranges from a maximum of 100, which reflects the best health status to a minimum of 0, which reflects the worst health status. The SF-12 Mental Component Summary scale ranges from a maximum of 100, which reflects the best health status to a minimum of 0, which reflects the worst health status. |
Baseline and one year follow-up
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Subject's Average Score on the EQ-5D- Quality of Life Questionnaire Over Time
Periodo de tiempo: Baseline and 1 Year
|
The EQ-5D is a standardized questionnaire that asks subjects to rate themselves (no problems, some problems, extreme problems) on mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.
The scale is indexed and ranges from a minimum of 0.275 and a maximum of 1.000.
A lower number indicates the participants experiences more problems and a higher number indicates the participants experiences fewer problems.
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Baseline and 1 Year
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Subject's Average White Blood Cell Count
Periodo de tiempo: Baseline, 3-6 Months, and 1 through 5 Years
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Laboratory analysis of White Blood Cell Count on blood drawn from subject; WBC fight infection.
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Baseline, 3-6 Months, and 1 through 5 Years
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Subject's Average Red Blood Cells Count
Periodo de tiempo: Baseline, 3-6 Months, and 1 through 5 Years
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Laboratory Analysis of Red Blood Cell Count on blood drawn from subjects; RBC carry oxygen.
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Baseline, 3-6 Months, and 1 through 5 Years
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Subject's Average Hemoglobin Count
Periodo de tiempo: Baseline, 3-6 months, and 1 through 5 years
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Laboratory Analysis of Hemoglobin Count on blood drawn from subjects.
Hemoglobin is an oxygen-carrying protein in red blood cells.
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Baseline, 3-6 months, and 1 through 5 years
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Subject's Average Hematocrit Percentage
Periodo de tiempo: Baseline, 3-6 Months, and 1 through 5 Years
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Laboratory Analysis of Hematocrit Percentage on blood drawn from subjects.
Hematocrit is the proportion of red blood cells to the fluid component(plasma) in the blood.
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Baseline, 3-6 Months, and 1 through 5 Years
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Subject's Average Platelet Count
Periodo de tiempo: Baseline, 3-6 Months, and 1 through 5 Years
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Laboratory Analysis of Platelet Count on blood drawn from subjects; platelets help with blood clotting.
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Baseline, 3-6 Months, and 1 through 5 Years
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Subject's Average Plasma Free Hemoglobin
Periodo de tiempo: Baseline, 3-6 Months, and 1 through 5 Years
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Laboratory Analysis of Plasma Free Hemoglobin on blood drawn from subjects.
This blood test measures the level of free hemoglobin in the liquid part of the blood (the serum).
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Baseline, 3-6 Months, and 1 through 5 Years
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Subject's Average Serum Creatinine
Periodo de tiempo: Baseline
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Laboratory Analysis of Serum Creatinine on blood drawn from subjects.
Creatinine blood test is a test that measures kidney function.
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Baseline
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Subject's Average International Normalized Ratio
Periodo de tiempo: Baseline, Discharge, 3-6 Months, 1 Year, 3 Years, and 5 Years
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Laboratory Analysis of International Normalized Ratio (INR) on blood drawn from subjects. The INR is a calculation based on results of a prothrombin time (PT). The PT is a blood test that measures the time it takes for the liquid portion (plasma) of the blood to clot. |
Baseline, Discharge, 3-6 Months, 1 Year, 3 Years, and 5 Years
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Subject's Average Partial Thromboplastin Time
Periodo de tiempo: Baseline, Discharge, 3-6 Months, 1 Year, 3 Years, and 5 Years
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Laboratory Analysis of partial thromboplastin time (PTT) on blood drawn from subjects.
PTT is a blood test that looks at how long it takes for the blood to clot.
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Baseline, Discharge, 3-6 Months, 1 Year, 3 Years, and 5 Years
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Subject's Average Prothrombin Time
Periodo de tiempo: Baseline, Discharge, 3-6 Months, 1 Year, 3 Years, and 5 Years
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Laboratory Analysis of Prothrombin Time (PT) on blood drawn from subjects.
The PT is a blood test that measures the time it takes for the liquid portion (plasma) of the blood to clot.
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Baseline, Discharge, 3-6 Months, 1 Year, 3 Years, and 5 Years
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Jerzy Sadowski, MD, John Paul II Hospital
- Investigador principal: Jacek Rozanski, MD, The Cardinal Stefan Wyszynski Institute of Cardiology
Publicaciones y enlaces útiles
Publicaciones Generales
- De La Fuente AB, Wright GA, Olin JM, Duhay FG, Kapelak B, Bochenek M, Bartus K, Sadowski J. Advanced Integrity Preservation Technology Reduces Bioprosthesis Calcification While Preserving Performance and Safety. J Heart Valve Dis. 2015 Jan;24(1):101-9.
- Bartus K, Litwinowicz R, Kusmierczyk M, Bilewska A, Bochenek M, Stapor M, Wozniak S, Rozanski J, Sadowski J, Kapelak B. Primary safety and effectiveness feasibility study after surgical aortic valve replacement with a new generation bioprosthesis: one-year outcomes. Kardiol Pol. 2018;76(3):618-624. doi: 10.5603/KP.a2017.0262. Epub 2018 Jan 3.
- Sadowski J, Bartus K, Kapelak B, Chung A, Stapor M, Bochenek M. Aortic valve replacement with a novel anti-calcification technology platform. Kardiol Pol. 2015;73(5):317-22. doi: 10.5603/KP.a2014.0214. Epub 2014 Nov 5.
- Bartus K, Litwinowicz R, Bilewska A, Stapor M, Bochenek M, Rozanski J, Sadowski J, Filip G, Kusmierczyk M, Kapelak B. Final 5-year outcomes following aortic valve replacement with a RESILIA tissue bioprosthesis. Eur J Cardiothorac Surg. 2021 Jan 29;59(2):434-441. doi: 10.1093/ejcts/ezaa311.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Isquemia miocardica
- Enfermedades cardíacas
- Enfermedades cardiovasculares
- Enfermedades Vasculares
- Arteriosclerosis
- Enfermedades arteriales oclusivas
- Enfermedades de las válvulas cardíacas
- Obstrucción del flujo de salida ventricular
- Enfermedad coronaria
- Enfermedad de la arteria coronaria
- Estenosis de la válvula aórtica
- Insuficiencia de la válvula aórtica
- Enfermedad de la válvula aórtica
Otros números de identificación del estudio
- 2010-03
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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