Band Versus Ring for Tricuspid Regurgitation

Официальное название

Flexible Band Versus Rigid Ring Annuloplasty for the Correction of Tricuspid

Обзор

Tricuspid regurgitation is common in patients with heart valve disease, both flexible band and rigid ring annuloplasty can correct this anomaly. However, there is no data to address which one can bring more benefits to these patients with combined heart valve disease. This study aims to prospectively compare the efficacy and long term outcomes of flexible band versus rigid ring annuloplasty for the correction of tricuspid regurgitation.

Вмешательства

• Процедура Tricuspid Annuloplasty
  Patients will undergo repair of tricuspid regurgitation

Первичные конечные точки

• A composite of reoperation for tricuspid regurgitation, progression of tricuspid regurgitation by two grades from baseline or the presence of severe tricuspid regurgitation, or death. [Срок оценки: at follow-up of 5 years]

Вторичные конечные точки (1)

• Mortality [Срок оценки: up to 3 months of intervention]

Критерии участия

Критерии включения

• 1\. Subject must be 18 years and 70 years at time of consent and must not be a member of a vulnerable population.
• 2\. Subject or a legally authorized representative (where allowed per local regulations) must provide written informed consent prior to any trial related procedure.
• 3\. Subjects with tricuspid regurgitation determined by the assessment of a qualifying transthoracic echocardiogram (TTE) and/or transesophageal echocardiogram (TEE).

Критерии исключения

• 1\. Patient unable or unwilling to provide informed consent;
• 2\. Subjects with mild tricuspid regurgitation;
• 3\. Emergency surgery;
• 4\. Prior tricuspid valve leaflet surgery or any currently implanted prosthetic tricuspid valve, or any prior transcatheter tricuspid valve procedure;
• 5\. Subjects with percutaneous coronary intervention within prior 30 days prior to enrollment;
• 6\. Subjects with presence of any known life threatening (non-cardiac major or progressive disease), non-cardiac disease that will limit the subject's life expectancy to less than one year;
• 7\. Subjects with permanent or temporary pacemaker implantation;
• 8\. Subjects with severe, irreversible pulmonary hypertension in the judgment of the investigator;
• 9\. History of mitral/tricuspid endocarditis within the last 12 months;
• 10\. Subjects with contraindication or known allergy to device's components, aspirin, anti-coagulation therapy or contrast media that cannot be adequately premeditated;
• 11\. Subjects with bleeding or coagulation disorders (e.g. active peptic ulcer or active gastrointestinal bleeding);
• 12\. Female patient is pregnant (urine HCG test result positive) or lactating;
• 13\. Subject is currently participating in another clinical trial that has not yet completed its primary endpoint;
• 14\. Subjects with left ventricular ejection fraction (LVEF)≤20%.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• The First Affiliated Hospital of Nanjing Medical University — Нанкин

Публикации

• Veen KM, Etnel JRG, Quanjel TJM, Mokhles MM, Huygens SA, Rasheed M, Oei FBS, Ten Cate FJ, Bogers AJJC, Takkenberg JJM. Outcomes after surgery for functional tricuspid regurgitation: a systematic review and meta-analysis. Eur Heart J Qual Care Clin Outcomes. 2020 Jan 1;6(1):10-18. doi: 10.1093/ehjqcco/qcz032. PMID 31287501

Идентификаторы

NCT: NCT04093297 · JPH2019

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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