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

26. maj 2026 opdateret af: 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Anslået)

250

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Tyskland
    • Bavaria
      • München, Bavaria, Tyskland, 80636
        • TUM Klinikum Deutsches Herzzentrum
        • Ledende efterforsker:
          • Markus Krane, Prof. Dr. med.

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Prøveudtagningsmetode

Sandsynlighedsprøve

Studiebefolkning

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.

Beskrivelse

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%

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
Edwards KONECT RESILIA AVC
Subjects who were treated with the Edwards KONECT RESILIA AVC
Enhed: Edwards KONECT RESILIA AVC
Surgical replacement of the aortic valve and ascending aorta with the Edwards KONECT RESILIA AVC

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percentage of participant's freedom from death and/or device related reintervention
Tidsramme: ≤ 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Participant's linearized rate of thromboembolism
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Edwards Lifesciences

Efterforskere

  • Ledende efterforsker: Markus Krane, Prof. Dr. med., TUM Universitätsklinikum Deutsches Herzzentrum

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

30. juni 2026

Primær færdiggørelse (Anslået)

31. december 2028

Studieafslutning (Anslået)

30. juni 2039

Datoer for studieregistrering

Først indsendt

26. maj 2026

Først indsendt, der opfyldte QC-kriterier

26. maj 2026

Først opslået (Faktiske)

2. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

2. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

26. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2025-02

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

Individual participant data will not be available to other researchers.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ja

produkt fremstillet i og eksporteret fra U.S.A.

Ja

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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