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Идёт набор NCT07726173

Transventricular Off-pump Mitral Valve Repair

Без фазы С лечением Mitral Valve (MV) 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: TRANSOM.
Кому может быть актуально
Состояния в реестре: Mitral Valve (MV) Regurgitation. Базовые параметры: от 21 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
Следующий шаг
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Официальное название

Transventricular Off-pump Mitral Valve Repair (TRANSOM)

Обзор

The purpose of this study is to assess the safety and effectiveness (usefulness) of an investigational technique used to repair the mitral valve for patients with mitral regurgitation due to a defective valve leaflet. This procedure is called trans-ventricular off-pump mitral valve repair (TRANSOM) and it repairs the mitral valve by replacing some of the cords that support the mitral valve. This type of repair is minimally-invasive since it is performed through a small incision and avoids making a breast-bone-splitting incision.

Подробное описание

The key advantages of TRANSOM are that it is less invasive, requiring a small non-rib-spreading chest incision rather than a sternotomy, which splits the breastbone.

Вмешательства

  • Устройство TRANSOM
    TRANSOM is a minimally-invasive treatment that involves making a small incision between the ribs of the left chest, inserting a thin tube directly into the heart while it is beating, and placing the suture material onto the edges of the valve flaps so that the valves come together properly.

Первичные конечные точки

  • Primary Safety Endpoint: Composite Freedom from Major Adverse Events [Срок оценки: 30 days post-index procedure, or at hospital discharge approximately 4 days post index procedure]
  • Primary Effectiveness Endpoint: Composite Freedom from Death, Recurrent mitral regurgitation (MR), and Re-intervention [Срок оценки: 1 year post-index procedure.]
Вторичные конечные точки (12)
  • Technical Success [Срок оценки: Exit from operating room and up to 30 days post-procedure.]
  • Procedural Success [Срок оценки: Exit from operating room and up to 30 days post-procedure.]
  • Patient Success [Срок оценки: 1 year post-index procedure.]
  • Blood Product Usage [Срок оценки: Perioperative through hospital discharge (an average of 4 days following the index procedure).]
  • Procedure Time [Срок оценки: During the index procedure.]
  • Operating Room Time [Срок оценки: During the index procedure.]
  • Percentage of Subjects Receiving Mitral Valve Replacement (MVR) [Срок оценки: During the index procedure.]
  • Composite Effectiveness Endpoint [Срок оценки: 1 year post-index procedure.]
  • Discharged to Home vs Other Facility [Срок оценки: At hospital discharge (an average of 4 days following the index procedure).]
  • New York Heart Association (NYHA) Functional Class [Срок оценки: Baseline and at 30 days, 12, 24, 36, 48, and 60 months post-procedure.]
  • Mitral Regurgitation Grade [Срок оценки: Baseline and at 7 days post-procedure or hospital discharge (whichever occurs first), 30 days, and 12, 24, 36, 48, and 60 months post-procedure.]
  • Left Ventricular End Diastolic Diameter (LVEDD) [Срок оценки: Baseline and at 7 days post-procedure or hospital discharge (whichever occurs first), 30 days, and 12, 24, 36, 48, and 60 months post-procedure.]

Критерии участия

Критерии включения

  • Age 21 years or older.
  • Presence of severe degenerative mitral regurgitation confirmed by echocardiography.
  • Mitral leaflet anatomy suitable for coaptation to allow reduction of mitral regurgitation without undue leaflet tension.
  • Ability to provide informed consent and willingness to comply with study procedures and follow-up.

Критерии исключения

  • Functional mitral regurgitation.
  • Severe mitral annular or leaflet calcification.
  • Significant concomitant valvular disease (e.g., severe aortic stenosis or insufficiency, severe tricuspid regurgitation).
  • Left ventricular ejection fraction <30% or severe right ventricular dysfunction.
  • Requirement for concomitant cardiac surgery.
  • Prior cardiac valve intervention or structural heart procedure (excluding prior PCI).
  • Recent major cardiovascular events (e.g., stroke or myocardial infarction within 30 days).
  • Hemodynamic instability or cardiogenic shock at the time of enrollment.
  • Significant comorbid conditions that increase procedural risk, including advanced liver disease, severe hematologic abnormalities, or active infection.
  • Contraindications to study procedures or required medications, including inability to tolerate anticoagulation or transesophageal echocardiography.
  • Pregnancy, lactation, or planned pregnancy during the study period.
  • Participation in another investigational device or drug study that could interfere with outcomes.
  • Life expectancy less than 12 months or any condition that, in the opinion of the investigator, precludes study participation.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

США · 1 центр
  • Johns Hopkins Hospital — Baltimore

Идентификаторы

NCT: NCT07726173 · IRB00416988

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗