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

16 lipca 2026 zaktualizowane przez: 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.

Przegląd badań

Status

Rekrutacyjny

Warunki

Interwencja / Leczenie

Szczegółowy opis

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.

Typ studiów

Obserwacyjny

Zapisy (Szacowany)

250

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Lokalizacje studiów

  • Niemcy
    • Bavaria
      • München, Bavaria, Niemcy, 80636
        • Rekrutacyjny
        • TUM Klinikum Deutsches Herzzentrum
        • Główny śledczy:
          • Markus Krane, Prof. Dr. med.

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Metoda próbkowania

Próbka prawdopodobieństwa

Badana populacja

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.

Opis

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 studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

Kohorty i interwencje

Grupa / Kohorta
Interwencja / Leczenie
Edwards KONECT RESILIA AVC
Subjects who were treated with the Edwards KONECT RESILIA AVC
Urządzenie: Edwards KONECT RESILIA AVC
Surgical replacement of the aortic valve and ascending aorta with the Edwards KONECT RESILIA AVC

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Percentage of participant's freedom from death and/or device related reintervention
Ramy czasowe: ≤ 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Participant's linearized rate of thromboembolism
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Edwards Lifesciences

Śledczy

  • Główny śledczy: Markus Krane, Prof. Dr. med., TUM Universitätsklinikum Deutsches Herzzentrum

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

25 czerwca 2026

Zakończenie podstawowe (Szacowany)

31 grudnia 2028

Ukończenie studiów (Szacowany)

30 czerwca 2039

Daty rejestracji na studia

Pierwszy przesłany

26 maja 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

26 maja 2026

Pierwszy wysłany (Rzeczywisty)

2 czerwca 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

17 lipca 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

16 lipca 2026

Ostatnia weryfikacja

1 lipca 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • 2025-02

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Opis planu IPD

Individual participant data will not be available to other researchers.

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Tak

produkt wyprodukowany i wyeksportowany z USA

Tak

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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