KONECT RESILIA Aortic Valved Conduit (AVC) Real-world Study Assessing Safety and Performance (KONECTION)
26. května 2026 aktualizováno: 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.
Přehled studie
Postavení
Zatím nenabíráme
Podmínky
Intervence / Léčba
Detailní popis
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 studie
Pozorovací
Zápis (Odhadovaný)
250
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní kontakt
- Jméno: Sabrina Hundt, PhD
- Telefonní číslo: +49 (0)151 67550601
- E-mail: Sabrina_Hundt@edwards.com
Studijní místa
-
-
Bavaria
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München, Bavaria, Německo, 80636
- TUM Klinikum Deutsches Herzzentrum
-
Vrchní vyšetřovatel:
- Markus Krane, Prof. Dr. med.
-
-
Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Ne
Metoda odběru vzorků
Ukázka pravděpodobnosti
Studijní populace
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.
Popis
Inclusion Criteria:
- 18 years or older at the time of informed consent
- 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
- Provide written informed consent
- Willing to follow protocol requirements
Exclusion Criteria:
- Active endocarditis or endocarditis within 3 months prior to the study index procedure
- Emergency procedure
- Stage 4 renal disease (estimated glomerular filtration rate [eGFR] <30 excluded) or requiring dialysis
- Less than 2-year life expectancy due to non-cardiovascular life-threatening disease in the opinion of the study investigator
- High predicted risk of mortality prior to the procedure: Society of Thoracic Surgeons Predicted Risk of Mortality (STS-PROM) ≥8%
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
Intervence / Léčba |
|---|---|
|
Edwards KONECT RESILIA AVC
Subjects who were treated with the Edwards KONECT RESILIA AVC
|
Surgical replacement of the aortic valve and ascending aorta with the Edwards KONECT RESILIA AVC
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Percentage of participant's freedom from death and/or device related reintervention
Časové okno: ≤ 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
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Participant's linearized rate of thromboembolism
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
|
Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Markus Krane, Prof. Dr. med., TUM Universitätsklinikum Deutsches Herzzentrum
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Odhadovaný)
30. června 2026
Primární dokončení (Odhadovaný)
31. prosince 2028
Dokončení studie (Odhadovaný)
30. června 2039
Termíny zápisu do studia
První předloženo
26. května 2026
První předloženo, které splnilo kritéria kontroly kvality
26. května 2026
První zveřejněno (Aktuální)
2. června 2026
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
2. června 2026
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
26. května 2026
Naposledy ověřeno
1. května 2026
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 2025-02
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
NE
Popis plánu IPD
Individual participant data will not be available to other researchers.
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Ne
Studuje produkt zařízení regulovaný americkým úřadem FDA
Ano
produkt vyrobený a vyvážený z USA
Ano
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