Echocardiographic Assessment of the Effect of Impella on Biventricular Function
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: Echocardiographic Assessment.
- Кому может быть актуально
- Состояния в реестре: End-stage Heart Failure. 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
- Список центров уточняется — проверьте первичный протокол.
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Обзор
The objective of this prospective observational study is to evaluate the effects of Impella 5.5 on biventricular function in adult patients with end-stage heart failure requiring temporary mechanical circulatory support. The study will assess changes in left and right ventricular global longitudinal strain and myocardial work, as well as additional echocardiographic and hemodynamic parameters. Measurements will be obtained at baseline prior to Impella implantation, immediately after device initiation, and during postoperative follow-up up to Day 14. This study involves collection of echocardiographic imaging and clinical data, including additional imaging performed for research purposes.
Подробное описание
This is a single-center, single-arm, prospective observational study designed to evaluate the effects of Impella 5.5 on left ventricular unloading and biventricular function in patients with end-stage heart failure requiring temporary mechanical circulatory support.
Echocardiographic assessments will be performed at three time points: prior to Impella implantation (baseline), immediately after device initiation intraoperatively, and during postoperative follow-up up to Day 14. Measurements will include left and right ventricular global longitudinal strain, myocardial work, and standard echocardiographic parameters such as left ventricular ejection fraction, ventricular volumes, and right ventricular functional indices.
Hemodynamic parameters, including arterial blood pressure, central venous pressure, pulmonary artery pressure, cardiac output, and mixed venous oxygen saturation, will also be collected. The vasoactive inotropic score will be calculated to evaluate changes in pharmacologic support.
This study is observational in nature and does not alter clinical management. Additional echocardiographic imaging may be obtained for research purposes in conjunction with standard of care procedures.
Вмешательства
- Диагностический тест Echocardiographic Assessment
Echocardiographic imaging will be performed at baseline prior to Impella implantation, immediately after device initiation, and during postoperative follow-up up to Day 14 to assess biventricular function.
Первичные конечные точки
- Mean Change from Baseline in Left Ventricular Global Longitudinal Strain (LV GLS) [Срок оценки: Baseline, immediately post-Impella initiation, and postoperative day up to Day 14]
- Mean Change from Baseline in Left Ventricular Myocardial Work (MW [Срок оценки: Baseline, immediately post-Impella initiation, and postoperative day up to Day14]
- Mean Change from Baseline in Right Ventricular Global Longitudinal Strain (RV GLS) [Срок оценки: Baseline, immediately post-Impella initiation, and postoperative day up to Day 14]
Вторичные конечные точки (8)
- Mean Change from Baseline in Left Ventricular Ejection Fraction (LVEF) [Срок оценки: Baseline, immediately post-Impella initiation, and postoperative day up to Day 14]
- Mean Change from Baseline in Left Ventricular End-Diastolic Volume (LVEDV) [Срок оценки: Baseline, immediately post-Impella initiation, and postoperative day up to Day 14]
- Mean Change from Baseline in Left Ventricular End-Systolic Volume (LVESV) [Срок оценки: Baseline, immediately post-Impella initiation, and postoperative day up to Day 14]
- Mean Change from Baseline in Right Ventricular Ejection Fraction (RVEF) [Срок оценки: Baseline, immediately post-Impella initiation, and postoperative day up to Day 14]
- Mean Change from Baseline in Right Ventricular End-Diastolic Volume (RVEDV) [Срок оценки: Baseline, immediately post-Impella initiation, and postoperative day up to Day 14]
- Mean Change from Baseline in Right Ventricular End-Systolic Volume (RVESV) [Срок оценки: Baseline, immediately post-Impella initiation, and postoperative day up to Day 14]
- Mean Change from Baseline in Tricuspid Annular Plane Systolic Excursion (TAPSE) [Срок оценки: Baseline, immediately post-Impella initiation, and postoperative day up to Day 14]
- Mean Change from Baseline in Right Ventricular Fractional Area Change (RV FAC) [Срок оценки: Baseline, immediately post-Impella initiation, and postoperative day up to Day 14]
Критерии участия
Критерии включения
- Adult patients over 18 years old
- Require Impella 5.5 implantation
Критерии исключения
- Patients' inability to provide consent for themselves (including that patients' lack of understanding the research)
- Any patients who are deemed at higher-than-normal risk for complications secondary to echocardiography, such as dysphagia or esophageal pathology
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Список центров уточняется — проверьте первичный протокол.
Идентификаторы
NCT: NCT07534462 · STUDY00010955