CHATEAU Registry: Clinical Outcomes After Transcatheter Aortic Valve Replacement
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Transcatheter Aortic Valve Replacement.
- Кому может быть актуально
- Состояния в реестре: Aortic Valve Stenosis, Transcatheter Aortic Valve Replacement (TAVR). Базовые параметры: от 18 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- South Korea
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Clinical Outcomes in Patients Undergoing Transcatheter Aortic Valve Replacement: The Collaborative Hexagon-Asian Transcatheter Aortic Valve Replacement Union (CHATEAU) Registry
Обзор
This study is a multicenter, retrospective registry study using the CHATEAU Registry. The study will evaluate patients who underwent transcatheter aortic valve replacement between January 2021 and December 2025. The purpose of the study is to assess clinical outcomes and valve performance after TAVR in real-world practice, with a focus on procedural strategies, valve-related factors, and long-term outcomes. Patient clinical information, imaging findings, procedural data, echocardiographic results, and follow-up outcomes will be collected from existing medical records. No additional intervention, treatment, or study-specific visit will be performed.
Подробное описание
The CHATEAU Registry is an international, multicenter, observational registry of patients undergoing transcatheter aortic valve replacement. This study will retrospectively analyze consecutive 4,000 patients treated with TAVR at participating centers from January 1, 2021 to December 31, 2025. Follow-up clinical outcomes will be assessed through December 31, 2027.
Eligible patients are adults who underwent TAVR for aortic valve disease. Data will be collected from existing medical records, including baseline demographics, comorbidities, laboratory findings, pre-procedural imaging data, procedural details, device information, post-procedural echocardiographic findings, discharge medications, and clinical follow-up outcomes.
The study aims to evaluate the association between patient-, anatomy-, device-, and procedure-related factors and subsequent clinical outcomes and valve performance. Outcomes of interest may include all-cause death, cardiovascular death, stroke, myocardial infarction, heart failure hospitalization, pacemaker implantation, valve hemodynamic deterioration, aortic valve reintervention, paravalvular regurgitation, and other TAVR-related clinical events.
Because this is a retrospective observational study, all treatment decisions were made according to routine clinical practice at each participating institution. The study does not involve randomization, assignment of treatment, additional procedures, or additional patient visits. All data will be handled in accordance with applicable institutional review board requirements and privacy regulations.
Вмешательства
- Процедура Transcatheter Aortic Valve Replacement
Transcatheter aortic valve replacement (TAVR) performed according to routine clinical practice using commercially available transcatheter heart valves and standard procedural techniques at participating centers.
Первичные конечные точки
- All-Cause Mortality [Срок оценки: From the index TAVR procedure through December 31, 2027 (up to approximately 6 years)]
Вторичные конечные точки (1)
- Cardiovascular Mortality Stroke Heart Failure Hospitalization Myocardial Infarction Aortic Valve Reintervention Valve Hemodynamic Deterioration Prosthetic Valve Endocarditis/thrombosis Permanent pace maker insertion Major Bleeding [Срок оценки: From the index TAVR procedure through December 31, 2027 (up to approximately 6 years)]
Критерии участия
Критерии включения
- Adults (≥18 years of age).
- Patients who underwent transcatheter aortic valve replacement (TAVR) for severe native aortic valve disease at participating centers.
- TAVR performed between January 1, 2021 and December 31, 2025.
- Availability of baseline procedural and follow-up clinical data in the institutional registry or medical records.
Критерии исключения
- Patients with insufficient clinical or procedural data for outcome assessment.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
South Korea · 1 центр
- The Catholic University of Korea, Eunpyeong St. Mary's Hospital — Seoul
Идентификаторы
NCT: NCT07709858 · CHATEAU-REG-001