Post-Market Clinical Follow-up Study on the Performance and Safety of the Aortic Root Cannula Used in Cardiopulmonary Bypass Surgery
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Primary Purpose To demonstrate the performance of the Bıçakcılar Aortic Root Cannula in patients for whom its use is planned, in accordance with the device's intended purpose as outlined in the user manual, taking into account the following aspects: bleeding, trauma, manipulation, placement and removal, compliance with the intended use, occlusion, retention of debris, effective use, and maintenance of its shape Secondary Objectives
- To obtain observational data on secondary evaluation parameters (demographic data, concomitant diseases and treatments, biochemistry and echocardiography findings, vital and cardiological assessments, perfusion and cardioplegia assessments)
- To evaluate the impact of the use of the Bıçakcılar Aortic Root Cannula on the development of adverse events and complications
- To conduct post-market clinical follow-up of the Bıçakcılar Aortic Root Cannula
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Gizem Özdemir, Biomedical Engineer
- Número de teléfono: +90 5346137760
- Correo electrónico: gizemozdemir@kocyasa.com
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
The aim of this study is not to prove a hypothesis defined by a specific objective-numerical expectation, but rather to compile the various outcomes resulting from the use of a medical device, using data obtained from all cases collected within a timeframe deemed clinically appropriate and sufficient. In this context, a minimum sample size is determined without considering an objective expectation or the Type I and Type II statistical errors accepted in the research.
The sample will be formed by including participants such that even for the option with the fewest patients operated on-among the four options comprising two operative procedures and two cannula types-there will be at least 5 cases. Since the selection of the appropriate cannula is determined by the surgeon based on the patient's condition and characteristics, this sample will, to some extent, attempt to reflect real-world data on cannula use on a small scale.
Descripción
Inclusion Criteria:
Patients who have consulted the Department of Cardiovascular Surgery and for whom the physician has decided to perform heart surgery using the cardiopulmonary bypass technique,
- Patients for whom the use of an aortic root cannula is planned during surgery
- Patients who, prior to surgery, have provided consent in the "Cardiovascular Surgery Department Information and Consent Form, Use of Patient Data for Educational and Research Purposes" section regarding the use of their data
Exclusion Criteria:
Patients known to have hypersensitivity to any of the materials used in the device components (PVC, ABS, stainless steel)
- Patients with calcified aorta, aortic valve insufficiency, occluded coronary arteries, the presence of adventitia or plaques, fibrosis in the aortic wall, or low arterial pressure Patients who have difficulty understanding the study and complying with it
- Patients who may pose a conflict of interest (e.g., relatives of employees of sponsoring companies)
- Patients who have participated in any clinical trial within the past 30 days
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
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1
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The Aortic Root Cannula and Vented Aortic Root Cannula are indicated for the administration of cardioplegic solutions during cardiac surgical procedures such as coronary artery bypass grafting, aortic valve replacement, mitral valve replacement, double valve replacement, and aortic valve replacement combined with coronary artery bypass grafting.
The Aortic Root Cannula (35 cm) is indicated for use in minimally invasive surgeries.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Presence of bleeding
Periodo de tiempo: It will be measured during the surgery up to 6 hours.
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Primary endpoints are structured to encompass all clinical use outcomes characterizing device performance.
Evaluation items directly related to the Bıçakcılar Vent Catheter will be measured using a Likert scale with values ranging from 1 to 5.
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It will be measured during the surgery up to 6 hours.
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Impact of trauma
Periodo de tiempo: It will be measured during the surgery up to 6 hours.
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It will be used 5-likert scale.
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It will be measured during the surgery up to 6 hours.
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Manipulation during placement
Periodo de tiempo: It will be measured during the surgery up to 6 hours.
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It will be used 5-likert scale.
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It will be measured during the surgery up to 6 hours.
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Catheter removal
Periodo de tiempo: It will be measured during the surgery up to 6 hours.
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It will be used 5-likert scale.
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It will be measured during the surgery up to 6 hours.
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
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
Otros números de identificación del estudio
- CIP-33001
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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