KONECT RESILIA Aortic Valved Conduit (AVC) Real-world Study Assessing Safety and Performance (KONECTION)
16 июля 2026 г. обновлено: 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.
Обзор исследования
Статус
Рекрутинг
Условия
Вмешательство/лечение
Подробное описание
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.
Тип исследования
Наблюдательный
Регистрация (Оцененный)
250
Контакты и местонахождение
В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.
Контакты исследования
- Имя: Sabrina Hundt, PhD
- Номер телефона: +49 (0)151 67550601
- Электронная почта: Sabrina_Hundt@edwards.com
Места учебы
-
-
Bavaria
-
München, Bavaria, Германия, 80636
- Рекрутинг
- TUM Klinikum Deutsches Herzzentrum
-
Главный следователь:
- Markus Krane, Prof. Dr. med.
-
-
Критерии участия
Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Нет
Метод выборки
Вероятностная выборка
Исследуемая популяция
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.
Описание
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%
Учебный план
В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.
Как устроено исследование?
Детали дизайна
Когорты и вмешательства
Группа / когорта |
Вмешательство/лечение |
|---|---|
|
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
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Percentage of participant's freedom from death and/or device related reintervention
Временное ограничение: ≤ 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
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Participant's linearized rate of thromboembolism
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
|
Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Спонсор
Следователи
- Главный следователь: Markus Krane, Prof. Dr. med., TUM Universitätsklinikum Deutsches Herzzentrum
Даты записи исследования
Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.
Изучение основных дат
Начало исследования (Действительный)
25 июня 2026 г.
Первичное завершение (Оцененный)
31 декабря 2028 г.
Завершение исследования (Оцененный)
30 июня 2039 г.
Даты регистрации исследования
Первый отправленный
26 мая 2026 г.
Впервые представлено, что соответствует критериям контроля качества
26 мая 2026 г.
Первый опубликованный (Действительный)
2 июня 2026 г.
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
17 июля 2026 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
16 июля 2026 г.
Последняя проверка
1 июля 2026 г.
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- 2025-02
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
НЕТ
Описание плана IPD
Individual participant data will not be available to other researchers.
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Нет
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Да
продукт, произведенный в США и экспортированный из США.
Да
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .