Идёт набор NCT06682910

Assessment of Safety and Accuracy of the Microtech System in Patients Undergoing Left Ventricular Assist Device Implantation

Без фазы С лечением Heart Failure

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: Microtech sensor pressure.
Кому может быть актуально: Состояния в реестре: Heart Failure. Базовые параметры: Без ограничений · 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: США, Израиль
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

An Early Feasibility Trial to Assess the Safety and Accuracy of the Microtech System in Heart Failure Patients Undergoing Left Ventricular Assist Device Implantation

Обзор

The Microtech-LVAD study is designed as a prospective, single arm, multi-center early feasibility study. Approximately 15 patients will be enrolled in the study. The study will be limited to patients in whom it is decided, based on routine clinical practice, that the LVAD will be implanted via a midline sternotomy. In the first 5 study patients, the device will be implanted in the RA; subsequently, the device will be implanted in the LA unless the patient is deemed at high risk of post-LVAD right heart failure, in which case the device will be placed in the RA

Подробное описание

Вмешательства

Устройство Microtech sensor pressure
Microtech sensor implantation

Первичные конечные точки

Co-Primary Efficacy Endpoint [Срок оценки: 6 months]
Co-Primary Safety Endpoint [Срок оценки: 1 month]

Вторичные конечные точки (7)

The earliest post-operative day at which "valid" pressure measurements can be made from the Microtech implant [Срок оценки: 1 month]
Accuracy of Microtech pressure measurements in comparison to those obtained simultaneously by pulmonary artery catheter [Срок оценки: pre procedure, 3-6 months]
Accuracy of Microtech pressure measurements in comparison to those obtained simultaneously by pulmonary artery catheter [Срок оценки: 1 year]
Anatomic stability of the implant over the observation period [Срок оценки: post operation, 1 month, 3-6 months, 9 months, 12 months]
The incidence of device-related adverse events [Срок оценки: 12 months]
Correlation of changes of sensor-measured atrial pressure [Срок оценки: 1 month, 3-6 months , 9months and 12 month]
Usability of the system [Срок оценки: baseline, 30-6 months, 12 months]

Критерии участия

Критерии включения

Patient is scheduled to undergo an elective LVAD implantation via midline sternotomy based on routine practice at the participating center.
Patient is characterized as INTERMACS profile 2 or greater.
Patient is able and willing to provide written informed consent.
Patient is willing and able to comply with all required post-procedure follow-up visits.

Критерии исключения

Pre-operative coagulopathy or thrombocytopenia
For an intended LA implant, patient has a device implanted in the left atrial appendage (e.g., WATCHMAN or similar device) or a mechanical mitral valve
Patient has an atrial myxoma
Patient has pre-operative evidence of thrombus in the chamber in which the device is intended to be implanted
Patient has a history of stroke or transient ischemic attack within 6 months prior to the index procedure
History of systemic or pulmonary thromboembolism or deep vein thrombosis (DVT) within the last 6 months
Patient has a history of congenital heart disease, including known atrial septal defect that is not corrected (including during the LVAD implantation procedure)
Patient has severe mitral regurgitation (for an LA implant) or severe tricuspid regurgitation (for an RA implant) that is not intended to be corrected during the LVAD implantation
Patient has known allergy to stainless steel or titanium
Patient has noncardiac comorbidity that, in the opinion of the Principal Investigator, may limit life expectancy to less than 1 year
Patient is pregnant or intends to become pregnant prior to completion of all protocol follow-up requirements
Patient is participating in another investigational study that has not reached its primary endpoint
Intraoperative identification of any anatomical finding that would preclude safe access to, or closure of, the intended atrial chamber, or fixation of the device within the chamber including, but not limited to:

Identification of thrombus in the atrium in which the device will be implanted
Atrial anatomy deemed to be too thin or fragile to accept the implant
Epicardial adhesions or any intraoperative finding that would complicate access or closure of the atrium in which the device is intended to be implanted

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет