The CINCH-FMR Post-Market Registry: Percutaneous Repair in Functional Mitral Regurgitation
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: Carillon Mitral Contour System.
- Кому может быть актуально
- Состояния в реестре: Functional Mitral Regurgitation, Mitral Regurgitation. 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
- Германия
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Обзор
This is a retrospective and prospective, multi-center, post-market observational registry study. The primary objective of this post market registry is to continue to evaluate the long term safety and performance of the Carillon® Mitral Contour System® (CMCS) in a commercial (post market) setting.
Подробное описание
There are more than 22 million people worldwide with heart failure, including 5.3 million in the United States . Functional mitral regurgitation (MR), leakage of the mitral valve due to dilation of the left ventricle and annulus, occurs as a consequence of Heart Failure. Cardiac Dimensions has developed proprietary technology designed to address functional mitral regurgitation in a minimally invasive manner.
Previous studies have established that the Carillon® therapy has caused a significant reduction in functional MR. This reduction in MR results in clinically significant improvements in exercise tolerance, quality of life, and thus overall function in a symptomatic heart failure population.
To supplement the findings from these previous studies, Cardiac Dimensions is conducting this post-market registry of the Carillon® Mitral Contour System® (CMCS) in patients with functional mitral regurgitation. This registry is a retrospective and prospective, multi-center, clinical registry designed to further characterize the acute and long-term safety and performance profile of the CMCS. Up to 250 implanted patients will be enrolled at up to 40 centers located in the European Union and countries that recognize the CE-mark as a valid marketing authorization.
Patients enrolled in the registry have received the Carillon implant and will be assessed to document the long-term safety and performance of the device. These patients will be followed according to routine standard of care post procedure follow up assessments.
Вмешательства
- Устройство Carillon Mitral Contour System
The Cardiac Dimensions Carillon Mitral Contour System (CMCS) is a medical device and consists of the following components: 1. A proprietary implant intended for permanent placement in the coronary sinus (CS)/great cardiac vein (GCV) 2. A catheter-based delivery system which consists of a curved CMCS delivery catheter (3.2mm outer diameter) and a handle assembly 3. A sizing catheter to enable the physician to estimate the overall CS/GCV dimensions so that an appropriately sized implant may be se
Первичные конечные точки
- Death [Срок оценки: 6 months]
- Death [Срок оценки: 12 months]
- Death [Срок оценки: 24 months]
- Death [Срок оценки: 3 years]
- Death [Срок оценки: 4 years]
- Death [Срок оценки: 5 years]
- Serious adverse events [Срок оценки: 6 months]
- Serious adverse events [Срок оценки: 12 months]
- Change in New York Heart Association (NYHA) classification [Срок оценки: 6, 12, and 24 months, and 3, 4, and 5 years]
- Rate of Heart Failure Hospitalizations [Срок оценки: 6 months]
Вторичные конечные точки (12)
- Change of MR Severity via Quantitative MR Variable: regurgitant volume (mL) [Срок оценки: 6, 12, and 24 months, and 3, 4, and 5 years]
- Change of MR Severity via Quantitative MR Variable: regurgitant fraction (%) [Срок оценки: 6, 12, and 24 months, and 3, 4, and 5 years]
- Change of MR Severity via Quantitative MR Variable: effective regurgitant orifice area (cm2 EROA) [Срок оценки: 6, 12, and 24 months, and 3, 4, and 5 years]
- Change of MR severity: Semi-Quantitative Parameter: Change in vena contract width [Срок оценки: 6, 12, and 24 months, and 3, 4, and 5 years]
- Change of MR severity: Semi-Quantitative Parameter: Change in MV EVmax. [Срок оценки: 6, 12, and 24 months, and 3, 4, and 5 years]
- Change of MR severity: Semi-Quantitative Parameter: Change in pulmonary vein flow. [Срок оценки: 6, 12, and 24 months, and 3, 4, and 5 years]
- Change in Left Atrial Area [Срок оценки: 6, 12, and 24 months, and 3, 4, and 5 years]
- Change in Left Atrial Diameter [Срок оценки: 6, 12, and 24 months, and 3, 4, and 5 years]
- Change in Left Atrial Volume Index [Срок оценки: 6, 12, and 24 months, and 3, 4, and 5 years]
- Change in Left Ventricular End Systolic Volume (LVESV) [Срок оценки: 6,12, and 24 months, and 3, 4, and 5 years]
- Change in Left Ventricular End Diastolic Volume (LVEDV) [Срок оценки: 6,12, and 24 months, and 3, 4, and 5 years]
- Change in Left Ventricular End Systolic Diameter (LVESD) [Срок оценки: 6,12, and 24 months, and 3, 4, and 5 years]
Критерии участия
Критерии включения
- Patients with functional mitral regurgitation (i.e., dilated cardiomyopathy), in accordance with CE-mark approved labeling
- Patients implanted with the Carillon device
- Patients must be ≥ 18 years old
- Patients require informed consent prior to inclusion in this registry
- Minimum baseline data, as described in CINCH Protocol, including:
- Hemodynamic measures (by echocardiography)
- Baseline must include the following measurements: MR grade, LVEF (%), LVEDD, LAD, and AP \& ML diameters
- NYHA Classification
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Только случаи
Центры проведения
Германия · 19 центров
- Universitätsklinikum Aachen — Aachen
- St. Marien Krankenhaus- Ahaus Vreden — Ahaus
- Sana Klinikum Lichtenberg — Berlin
- Klinikum Links der Weser — Bremen
- Kardiovaskular Zentrum Darmstadt — Darmstadt
- Herzzentrum Dresden — Dresden
- Cardiovascular Center Frankfurt — Frankfurt
- Universtitätsklinikum Frankfurt — Frankfurt
- … и ещё 11 центров
Идентификаторы
NCT: NCT05677568 · PMS-1681-01