Study of Transcatheter Tricuspid Annular Repair

Обзор

The purpose of the study is to evaluate the safety and performance of the MIA Minimally Invasive Annuloplasty Device in patients with chronic functional tricuspid regurgitation.

Подробное описание

The purpose of the study is to evaluate the safety and performance of the MIA Minimally Invasive Annuloplasty Device in patients with chronic functional tricuspid regurgitation. The study is a prospective, multi-center safety and performance study. Enrolled subjects will be assessed for clinical follow-up at 1 month, 6 months, and 1 year post implant procedure.

Вмешательства

• Устройство MIA, Minimally Invasive Annuloplasty Device - Surgical
  Eligible patients will receive implantation of MIA implants deployed using the MIA, Minimally Invasive Annuloplasty Device from an open surgical approach
• Устройство MIA, Minimally Invasive Annuloplasty Device - Percutaneous
  Eligible patients will receive implantation of MIA implants deployed using the MIA, Minimally Invasive Annuloplasty Device from a percutaneous approach

Первичные конечные точки

• Major Adverse Events [Срок оценки: 30 days]
• Reduction in tricuspid regurgitation at 30 days [Срок оценки: 30 days]

Вторичные конечные точки (3)

• Serious Adverse Events (SAEs) and Serious Adverse Device Events (SADE) [Срок оценки: 3 months]
• Reduction in tricuspid regurgitation [Срок оценки: 3 months]
• Quality of Life Measurement [Срок оценки: 3 months]

Критерии участия

Критерии включения

• Chronic functional tricuspid regurgitation (FTR) with a minimum of moderate tricuspid regurgitation (2-4)
• Age≥18 and ≤85 years old
• New York Heart Association (NYHA) Class II, III or ambulatory IV
• Left ventricular ejection fraction (LVEF) ≥30%
• Undergoing cardiac surgical procedure with the planned use of cardiopulmonary bypass (surgical arm only)
• Functional tricuspid valve regurgitation pathology with a structurally normal valve; and tricuspid valve annular diameter ≥ 40 mm (or 21 mm/m2) and ≤55 mm (or 29 mm/m2) or 2-4 + FTR
• Patient provides written Informed Consent before any study-specific tests or procedures are performed
• Patient is willing and able to comply with all specified study evaluations

Критерии исключения

• Pregnant or lactating female
• Severe uncontrolled hypertension (SBP ≥ 180 mmHg and/or DBP ≥ 110 mmHg)
• Previous tricuspid valve repair or replacement
• Myocardial Infarction or known unstable angina within the 30-days prior to the index procedure
• Any PCI within 30 days prior to the index procedure or planned 3 months post the index procedure
• Life expectancy of less than 12-months
• Severe right heart dysfunction
• Pulmonary hypertension with PA mean 2/3 rd MAP
• Active systemic infection
• Pericardial infection
• Any clinical evidence that the investigator feels would place the patient at increased risk with the deployment of the device
• Co-morbid conditions that place the subject at an unacceptable surgical risk (e.g. severe chronic obstructive pulmonary disease, hepatic failure, cardiac disease, autoimmune disorders or conditions of severe immunosuppression)
• Untreated coronary artery disease (CAD) requiring revascularisation unless CABG procedure is concomitant with MIA tricuspid annular repair (surgical arm only)
• Haemodynamic instability: systolic blood pressure <90mmHg without reduction of afterload, shock, need for inotropic medication or IABP
• Active peptic ulcer or gastrointestinal (GI) bleeding in the past 3 months
• Cerebrovascular event within the past 6 months
• History of mitral/tricuspid endocarditis within the last 12 months
• Organic tricuspid disease
• Contraindication or known allergy to device's components, aspirin, anti-coagulation therapy or contrast media that cannot be adequately premeditated
• Known alcohol or drug abuser
• Currently participating in the study of an investigational drug or device

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Литва · 2 центра

• Lithuanian University of Health Sciences — Kaunas
• Vilnius University Hospital Santariskiu Klinikos — Vilnius

Дания · 1 центр

• Aarhus University Hospital — Aarhus

Венгрия · 1 центр

• Semmelweis University, Heart and Vascular Center — Budapest

Латвия · 1 центр

• Centre of Cardiology, Pauls Stradins Clinical University Hospital — Riga

Польша · 1 центр

• The Cardinal Stefan Wyszyński Institute of Cardiology — Warsaw

Идентификаторы

NCT: NCT03692598 · MID-002

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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