Safety and Efficacy of the HighLife Transcatherter Mitral Valve Replacement System in Patients With Moderate-severe or Severe Mitral Regurgitation in China

Официальное название

A Prospective, Multicentric Clinical Trial Protocol to Evaluate the Safety and Efficacy of the HighLife Trans-Septal Transcatheter Mitral Valve Replacement System for the Treatment of Moderate-severe or Severe Mitral Regurgitation With Single-arm Objective Performance Criteria

Обзор

To observe and evaluate the safety and efficacy of the HighLife Transcatheter Mitral Valve Replacement System in patients with moderate-severe or severe mitral valve regurgitation through a prospective, multicenter clinical trial using objective performance criteria.

Вмешательства

• Устройство the HighLife Trans-Septal Transcatheter Mitral Valve Replacement System
  The HighLife TMVR system is composed of a Transcatheter Mitral Valve (TMV), a subannular implant (SAI), and their delivery systems and accessories. The TMV is a 28mm mitral bioprosthesis made of a self-expanding Nitinol frame covered with polyester graft and supporting bovine pericardium leaflets. The bioprosthesis is used in conjunction with the Sub-Annular Implant (SAI), comprising a ring (made of polycarbonate urethane (PCU), nitinol, gold markers and polyester (Dacron) to be placed around th

Первичные конечные точки

• All-cause mortality at 12 months [Срок оценки: 12 months]

Вторичные конечные точки (3)

• Technical success [Срок оценки: Immediate after procedure]
• Cardiac function change [Срок оценки: 30 days, 6 months, 12 months, 2 years, 3 years, 4 years and 5 years]
• Quality of life of patients [Срок оценки: 30 days, 6 months, 12 months, 2 years, 3 years, 4 years and 5 years]

Критерии участия

Критерии включения

• Patients who voluntarily participate and sign the informed consent form and can cooperate with the completion of the entire trial process;
• Age ≥ 18 years old;
• Moderate-severe or severe mitral regurgitation (≥3+); Note 1: Patients with ischemic or non-ischemic heart disease induced symptomatic secondary mitral regurgitation as the primary cause must be treated for at least 1 month after optimal guideline medical therapy (GDMT). Echocardiography should be performed 3 months after cardiac resynchronization therapy and 1 month after coronary revascularization to assess the degree of regurgitation.

Note 2: For patients with primary mitral regurgitation, the multidisciplinary cardiac team of the research center needs to use a standard scoring system, considering multiple factors such as complications, frailty, and disability, ensuring the enrolled with a high risk of surgery.

• Patients with New York Heart Association (NYHA) functional ratings are Class II, III, or ambulatory Class IV;
• Anatomically appropriate for treatment with the HighLife Transcatheter Mitral Valve Replacement System.

Критерии исключения

• Patients had any stroke/TIA within 30 days;
• Patients with severe symptomatic bilateral carotid stenosis (>70% stenosis on non-invasive imaging);
• Patients with active infection requiring antibiotic therapy;
• Patients with active ulcer or gastrointestinal bleeding within the past 3 months;
• Patients with history of coagulopathy or refuse future blood transfusion;
• Patients unable to undergo transesophageal echocardiography (TEE);
• Patients who are pregnant or breastfeeding, or planning to have children within 12 months;
• Patients who are unable to adhere to the follow-up schedule and complete the examination;
• Patients enrolled in other clinical studies and within the follow-up period;
• Patients with known allergies to device components or contrast agents;
• Patients unable to receive anticoagulant or antiplatelet therapy;
• Patients with a life expectancy of less than 12 months due to non-cardiac disease;
• Patients requiring emergency surgical treatment;
• Patients scheduled for cardiac surgery within 12 months;
• Patients with an inappropriate mitral annulus or leaflet size (<30 mm and >45 mm);
• Patients with moderate or above mitral stenosis;
• Flail mitral leaflets, or moderate to severe mitral valve prolapse;
• Patients with severe hepatic or renal insufficiency;
• Patients with severe calcification of the mitral annulus and/or mitral leaflets;
• Patients with history of mitral valve surgery or interventional therapy, or left atrial appendage occlusion device;
• Patients had acute myocardial infarction (MI) (Q-wave MI, or non-Q-wave MI, with CK-MB twice the normal and/or T-MB) within the past 1 month;
• Patients with untreated symptomatic coronary lesions requiring revascularization;
• Patients with untreated severe aortic stenosis and severe aortic regurgitation;
• Patients with aortic valve prosthesis;
• Patients with severe tricuspid valve lesions requiring surgical intervention;
• Patients with significant right ventricular dysfunction (such as biliteral lower extremities edema with increased jugular vein pulsation and hepatomegaly;
• LVEF < 30%; LVEDD > 70 mm;
• Patients with echocardiographically confirmed intracardiac mass, thrombus or neoplasm;
• Hypertrophic obstructive cardiomyopathy (HOCM);
• Patients with active or recent (within 3 months) endocarditis;
• Patients with definite non-left heart disease induced severe pulmonary hypertension (echocardiographic indication: systolic pulmonary artery pressure (SPAP) > 70 mmHg)
• Patients with hypotension (systolic blood pressure <90 mmHg) occurring within 7 days or mechanical hemodynamic support.

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

Китай · 1 центр

• Peiga Medical Technology (Suzhou) Co. — Сучжоу

Идентификаторы

NCT: NCT05610566 · 23CSP001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗