Идёт набор NCT05298124

Transcatheter Mitral Valve Repair for Inotrope Dependent Cardiogenic Shock

Без фазы С лечением Cardiogenic Shock 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: Transcatheter edge-to-edge repair, Medical therapy.
Кому может быть актуально: Состояния в реестре: Cardiogenic Shock, 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: США, Канада
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

Mitral regurgitation may be seen in the setting of cardiogenic shock. Transcatheter edge-to-edge repair (TEER) has been shown to improve outcomes in patients with chronic heart failure. Observational studies suggest improvements in clinical outcomes in patients with mitral regurgitation in the setting of cardiogenic shock; however, there remains a lack of randomized clinical data to support the use of TEER in cardiogenic shock. This study will be a multicenter, open-label, randomized-controlled trial with two study arms: medical therapy and TEER. Patients admitted to the Cardiac Intensive Care Unit (CICU), Cardiac Surgery Intensive Care Unit (CSICU) or Intensive Care Units (ICU) at participating centers will be recruited. The study aims to answer the question: "Does TEER in patients with SCAI stage C or D cardiogenic with concomitant moderate or greater mitral regurgitation improve outcomes as compared to medical therapy?" The study hypothesis is that TEER will lead to an overall improvement in the composite outcome as compared to the medical therapy arm.

Подробное описание

Current management strategies for patients with SCAI stage C through E cardiogenic shock include management in a cardiac intensive care unit (CICU) or cardiac surgery intensive care unit (CSICU) with intravenous inotropes (i.e. medications to increase the pumping function of the heart), vasopressors (i.e. medications to increase blood pressure), ventilatory support, and/or mechanical circulatory support. Importantly, with the exception of revascularization, little data exists demonstrating the ability to alter prognosis in patients with cardiogenic shock.

This study will be divided into two phases, as follows:

Phase 1 (Vanguard) - The first phase of this study will be composed of a feasibility stage where a total of 10 participants from centers in Ontario, Canada will be recruited. The primary objective of this phase is to ascertain feasibility of participant recruitment and treatment. Feasibility would be considered met if 10 participants were enrolled 12 months from the date of activation of all four centers.

Phase 2 - The second phase of this study will be a continuation of Phase 1 where the remaining 134 participants, for a total of 144 participants in the overall study. For this second phase of the study, patients will be recruited from high-volume TEER centers in Canada and the United States - with participating centers performing more than 25 TEER procedures per year.

Eligible participants will be randomly assigned in a 1:1 fashion to the medical therapy arm (i.e. control arm) or the TEER arm (i.e. intervention arm) of the trial.

Вмешательства

Устройство Transcatheter edge-to-edge repair
Transcatheter edge-to-edge repair
Другое Medical therapy
Medical treatment in an intensive care unit

Первичные конечные точки

Primary composite outcome [Срок оценки: Through duration of hospitalization, generally up to 12 weeks following admission]

Вторичные конечные точки (10)

In hospital all-cause mortality [Срок оценки: Through duration of hospitalization, generally up to 12 weeks following admission]
In hospital implantation of durable left-ventricular assist device or cardiac transplantation [Срок оценки: Through duration of hospitalization, generally up to 12 weeks following admission]
Discharge on inotropes [Срок оценки: Through duration of hospitalization, generally up to 12 weeks following admission]
Residual mitral regurgitation [Срок оценки: Through duration of hospitalization, generally up to 12 weeks following admission]
Technical success [Срок оценки: Measured at exit from procedure room, generally 2 hours after implant]
Device success [Срок оценки: At time of discharge from hospitalization, generally up to 12 weeks following admission]
Stroke or transient ischemic attack [Срок оценки: Through duration of hospitalization, generally up to 12 weeks following admission]
Bleeding [Срок оценки: Through duration of hospitalization, generally up to 12 weeks following admission]
Vascular access complications [Срок оценки: Through duration of hospitalization, generally up to 12 weeks following admission]
Cardiac structural complications [Срок оценки: Through duration of hospitalization, generally up to 12 weeks following admission]

Критерии участия

Критерии включения

Participants or substitute decision maker is able and willing to provide written informed consent
Age ≥ 18 years
SCAI stage C or D cardiogenic shock with persistent inotrope/vasopressor/non-durable mechanical support or unable to wean ventilatory support due to pulmonary edema for 24 hours prior to randomization
Greater than or equal to 3+ MR as determined by a study center's transesophageal echocardiogram (TEE)
In the opinion of the study center's heart team the participant is anatomically eligible for TMVr with the potential to achieve <3+ MR

Критерии исключения

Unwilling or unable to obtain informed consent from the participant or substitute decision maker
Revascularization of coronary artery disease performed in the 48 hours prior to randomization
If the mechanism of MR is deemed to be degenerative, in the opinion of the heart team the participant is eligible for surgical intervention
Prior mitral valve leaflet surgery or implanted mitral valve prosthesis (excluding ring)
Echocardiographic evidence of left sided intracardiac mass or thrombus
Diagnosis of active infective endocarditis
Transesophageal echocardiogram is contraindicated
Mitral valve anatomy deemed contraindication to TMVr implantation that cannot be addressed procedurally as determined by the study center's heart team
Any aortic valve disease greater than moderate in severity
A known hypersensitivity or contraindication to procedure medications which cannot be adequately managed medically
Out of hospital cardiac arrest or in-hospital cardiac arrest without documented neurologic recovery
Plan for durable mechanical circulatory support implantation prior to TMVr
In the opinion of the treating team, there is a significant comorbidity that would limit life expectancy in hospital
Pregnant or planning to become pregnant in the next 6 months.

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

Здоровые добровольцы: Нет