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KONECT RESILIA Aortic Valved Conduit (AVC) Real-world Study Assessing Safety and Performance (KONECTION)

16 de julio de 2026 actualizado por: Edwards Lifesciences
KONECTION is a prospective, observational, single-arm, multicenter study designed to collect real-world clinical outcomes in up to 250 participants who will receive the KONECT RESILIA aortic valved conduit, Model 11060A.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Descripción detallada

Subjects in the KONECTION study will be enrolled at up to 20 sites in Europe and Canada. The population will be participants requiring replacement of their diseased native or prosthetic aortic valve, and the associated repair or replacement of a damaged or diseased ascending aorta.

Tipo de estudio

De observación

Inscripción (Estimado)

250

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Ubicaciones de estudio

  • Alemania
    • Bavaria
      • München, Bavaria, Alemania, 80636
        • Reclutamiento
        • TUM Klinikum Deutsches Herzzentrum
        • Investigador principal:
          • Markus Krane, Prof. Dr. med.

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Método de muestreo

Muestra de probabilidad

Población de estudio

The target population includes adult candidates who require replacement of their native or prosthetic aortic valve, and the associated repair or replacement of a damaged or diseased ascending aorta.

Descripción

Inclusion Criteria:

  1. 18 years or older at the time of informed consent
  2. Have a diseased native or prosthetic aortic valve and a damaged or diseased ascending aorta that requires aortic valved conduit replacement surgery with the KONECT RESILIA AVC
  3. Provide written informed consent
  4. Willing to follow protocol requirements

Exclusion Criteria:

  1. Active endocarditis or endocarditis within 3 months prior to the study index procedure
  2. Emergency procedure
  3. Stage 4 renal disease (estimated glomerular filtration rate [eGFR] <30 excluded) or requiring dialysis
  4. Less than 2-year life expectancy due to non-cardiovascular life-threatening disease in the opinion of the study investigator
  5. High predicted risk of mortality prior to the procedure: Society of Thoracic Surgeons Predicted Risk of Mortality (STS-PROM) ≥8%

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

Cohortes e Intervenciones

Grupo / Cohorte
Intervención / Tratamiento
Edwards KONECT RESILIA AVC
Subjects who were treated with the Edwards KONECT RESILIA AVC
Dispositivo: Edwards KONECT RESILIA AVC
Surgical replacement of the aortic valve and ascending aorta with the Edwards KONECT RESILIA AVC

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Percentage of participant's freedom from death and/or device related reintervention
Periodo de tiempo: ≤ 30 days
Participants' freedom from valve-related death or valve- and/or graft-related reintervention. Time to events were estimated by Kaplan-Meier method.
≤ 30 days

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Participant's linearized rate of thromboembolism
Periodo de tiempo: Events occurring ≥ 31 days and up through 5 years post-implant
A linearized rate percentage is calculated by the following equation: [(Total number of late adverse events in each category/total number of late patient years) x 100]. Late adverse events are events that occur ≥ 31 days post-implant through each subject's last follow-up visit or contact. Late patient years are calculated by totaling the amount of time the valve is implanted in the patient while participating in the trial and the count begins at ≥ 31 days post-implant through all subject's last follow-up visit or contact.
Events occurring ≥ 31 days and up through 5 years post-implant
Participant's linearized rate of valve thrombosis
Periodo de tiempo: Events occurring ≥ 31 days and up through 5 years post-implant
A linearized rate percentage is calculated by the following equation: [(Total number of late adverse events in each category/total number of late patient years) x 100]. Late adverse events are events that occur ≥ 31 days post-implant through each subject's last follow-up visit or contact. Late patient years are calculated by totaling the amount of time the valve is implanted in the patient while participating in the trial and the count begins at ≥ 31 days post-implant through all subject's last follow-up visit or contact.
Events occurring ≥ 31 days and up through 5 years post-implant
Participant's linearized rate of major paravalvular leak
Periodo de tiempo: Events occurring ≥ 31 days and up through 5 years post-implant
A linearized rate percentage is calculated by the following equation: [(Total number of late adverse events in each category/total number of late patient years) x 100]. Late adverse events are events that occur ≥ 31 days post-implant through each subject's last follow-up visit or contact. Late patient years are calculated by totaling the amount of time the valve is implanted in the patient while participating in the trial and the count begins at ≥ 31 days post-implant through all subject's last follow-up visit or contact.
Events occurring ≥ 31 days and up through 5 years post-implant
Participant's linearized rate of endocarditis
Periodo de tiempo: Events occurring ≥ 31 days and up through 5 years post-implant
A linearized rate percentage is calculated by the following equation: [(Total number of late adverse events in each category/total number of late patient years) x 100]. Late adverse events are events that occur ≥ 31 days post-implant through each subject's last follow-up visit or contact. Late patient years are calculated by totaling the amount of time the valve is implanted in the patient while participating in the trial and the count begins at ≥ 31 days post-implant through all subject's last follow-up visit or contact.
Events occurring ≥ 31 days and up through 5 years post-implant
Participant's linearized rate of major hemorrhage
Periodo de tiempo: Events occurring ≥ 31 days and up through 5 years post-implant
A linearized rate percentage is calculated by the following equation: [(Total number of late adverse events in each category/total number of late patient years) x 100]. Late adverse events are events that occur ≥ 31 days post-implant through each subject's last follow-up visit or contact. Late patient years are calculated by totaling the amount of time the valve is implanted in the patient while participating in the trial and the count begins at ≥ 31 days post-implant through all subject's last follow-up visit or contact.
Events occurring ≥ 31 days and up through 5 years post-implant
Percentage of participant's with freedom from death and/or device related reintervention
Periodo de tiempo: 1-, 2-, 3-, 4-, 5-, 6-, 7-, 8-, 9-, and 10- Years follow-up
Participants' freedom from valve-related death or valve- and/or graft-related reintervention. Time to events were estimated by Kaplan-Meier method.
1-, 2-, 3-, 4-, 5-, 6-, 7-, 8-, 9-, and 10- Years follow-up
Participant's functional improvement over time from baseline for New York Heart Association (NYHA) Class
Periodo de tiempo: Baseline, 1 month, 1-, 2-, 3-, 4-, 5-, 6-, 7-, 8-, 9-, and 10- Years follow-up

The New York Heart Association 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 anginal syndrome may be present even at rest.
Baseline, 1 month, 1-, 2-, 3-, 4-, 5-, 6-, 7-, 8-, 9-, and 10- Years follow-up
Participant's average mean gradient measurement over time
Periodo de tiempo: 1 month, 1-, 3-, and 5- Years follow-up
Mean gradient is the average flow of blood through the aortic valve measured in millimeters of mercury. Gradients are evaluated by echocardiography over time. In general, a higher value is considered worse, and a lower value is considered better but the value is dependent on the size and type of valve.
1 month, 1-, 3-, and 5- Years follow-up
Participant's average peak gradient measurement over time
Periodo de tiempo: 1 month, 1-, 3-, and 5- Years follow-up
Peak gradient is the maximum value measured of flow of blood through the aortic valve as measured in millimeters of mercury. Gradients are evaluated by echocardiography over time. In general, a higher valve is considered worse, and a lower value is considered better, but the value is dependent on the size and type of valve.
1 month, 1-, 3-, and 5- Years follow-up
Participant's average Effective Orifice Area (EOA) measurement over time
Periodo de tiempo: 1 month, 1-, 3-, and 5- Years follow-up
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. In general, a higher value is considered better, and a lower value is considered worse, but the value is dependent on the size and type of valve.
1 month, 1-, 3-, and 5- Years follow-up
Participant's average Effective Orifice Area Index (EOAI) measurement over time
Periodo de tiempo: 1 month, 1-, 3-, and 5- Years follow-up
Effective orifice area index represents the minimal cross-sectional area of the blood flow downstream of the aortic valve divided by the person's body surface area. Effective orifice area index is evaluated by echocardiography over time. In general, a higher value is considered better, and a lower value is considered worse, but the value is dependent on the size of the patient and the size and type of valve.
1 month, 1-, 3-, and 5- Years follow-up

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Edwards Lifesciences

Investigadores

  • Investigador principal: Markus Krane, Prof. Dr. med., TUM Universitätsklinikum Deutsches Herzzentrum

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

25 de junio de 2026

Finalización primaria (Estimado)

31 de diciembre de 2028

Finalización del estudio (Estimado)

30 de junio de 2039

Fechas de registro del estudio

Enviado por primera vez

26 de mayo de 2026

Primero enviado que cumplió con los criterios de control de calidad

26 de mayo de 2026

Publicado por primera vez (Actual)

2 de junio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

17 de julio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

16 de julio de 2026

Última verificación

1 de julio de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 2025-02

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Descripción del plan IPD

Individual participant data will not be available to other researchers.

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

Sí

producto fabricado y exportado desde los EE. UU.

Sí

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