Hamburg TranscathEteR Mitral Valve REplacement RegiStry
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
- Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
- Кому может быть актуально
- Состояния в реестре: Mitral Valve Disease. Базовые параметры: 18 лет — 110 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
- Германия
- 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
Hamburg Transcatheter Mitral Valve Replacement Registry
Обзор
The Hamburg TranscathEteR Mitral Valve REplacement RegiStry (HERMES) is a prospective clinical cohort registry aiming to gather follow-up information on short- and long-term outcome of patients with mitral valve disease that undergo transcatheter mitral valve replacement (TMVR) screening. In particular, long-term durability and function of implanted bioprosteses is of utmost interest for both patients and clinicians. Moreover, this study aimes to investigate and compare the different treatment strategies patients undergo after successful or unsuccessful screening for TMVR.
Подробное описание
Mitral valve regurgitation (MR) emerges as the most frequent valvular heart disease in developed coun-tries with prevalence increasing with age. Mitral valve repair is the gold standard therapeutic strategy in primary MR and is recommended in patients with secondary MR who are in need of revascularization. However, in patients with secondary MR mitral valve repair is associated with a higher rate of MR recurrence compared to mitral valve replacement. Nevertheless, elderly patients often are at high or prohibitive surgical risk and up to one half of all patients with severe MR are not referred to surgery. Transcatheter edge-to-edge mitral valve repair (TEER) constitutes a feasible and effective alternative, but eligibility for TEER is limited in some cases due to suboptimal anatomy or risk of mitral stenosis. Moreover, MR reduction is less predictable and, again, MR may reoccur. Transcatheter mitral valve replacement (TMVR) represents a complementary therapeutic approach for patients with severe MR. This novel therapy promises to reduce MR as durable as surgical valve replacement while reducing the procedural risk with an interventional approach.
The Hamburg TranscathEteR Mitral Valve REplacement RegiStry (HERMES) is a prospective clinical cohort registry aiming to gather follow-up information on short- and long-term outcome of patients with significant mitral valve disease, at high surgical risk with suboptimal anatomy for TEER, who undergo TMVR screening. In particular, long-term durability and function of implanted bioprosteses will be investigated. Additionally, this study aimes to investigate and compare the different treatment strategies patients undergo after successful or unsuccessful screening for TMVR (i.e., TMVR, TEER, surgery and medical therapy).
Первичные конечные точки
- All-cause mortality [Срок оценки: 6-60 months]
- Cardiovascular mortality [Срок оценки: 6-60 months]
- Rehospitalization for congestive heart failure [Срок оценки: 6-60 months]
- Unplanned mitral valve intervention [Срок оценки: 6-60 months]
- Mitral regurgitation (MR) severity [Срок оценки: 6-60 months]
Вторичные конечные точки (3)
- Change in 6-minute-walking-test (6MWT) distance [Срок оценки: 6-60 months]
- Change in quality of life [Срок оценки: 6-60 months]
- Change in New York Heart Association (NYHA) functional class [Срок оценки: 6-60 months]
Критерии участия
Критерии включения
- Ability to provide written informed consent in accordance with Good Epidemiological Practice and local legislation.
- Individuals over the age of 18 years.
- Patients with clinically relevant mitral valve disease, who undergo screening for TMVR.
Критерии исключения
- Insufficient knowledge of the German language, to understand study documents and interview without translation
- Physical or psychological incapability to cooperate in the investigation
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Германия · 1 центр
- University Heart and Vascular Center Hamburg — Hamburg
Идентификаторы
NCT: NCT04914468 · HERMES