Feasibility Study of Treating Tricuspid Regurgitation With K-ClipTM Transcatheter Annuloplasty System

Официальное название

Feasibility Study of Treating Tricuspid Regurgitation With K-ClipTM Transcatheter

Обзор

Evaluate the effectiveness and safety of the transcatheter tricuspid annuloplasty system manufactured by Shanghai Huihe Medical Technology Co., Ltd. for the treatment of patients with moderate-severe or worse tricuspid regurgitation

Вмешательства

• Устройство Transcatheter Annuloplasty
  Under echocardiography guidance, the transcatheter tricuspid annuloplasty system precisely reaches the specified position in the tricuspid valve region via jugular vein and superior vena cava approach. The enlarged tricuspid annular tissue is clamped with the clamp cpart and anchor part to reduce the perimeter of tricuspid annulus, so that the area of tricuspid orifice that could not be coapted is reduced. It plays the purpose of minimally invasive treatment of tricuspid valve.

Первичные конечные точки

• Success rate 1year after operation [Срок оценки: 1-year after operation]
• Success rate of operation [Срок оценки: intra-procedure]
• Success rate of device implantation [Срок оценки: intra-procedure]
• Change in echocardiographic parameters [Срок оценки: 30 days, 6 Months, 12 Months, annual for five years]
• Change in echocardiographic parameters [Срок оценки: 30 days, 6 Months, 12 Months, annual for five years]
• Change of Tricuspid Regurgitation Grade [Срок оценки: 30 days, 6 Months, 12 Months, annual for five years]
• NYHA Functional Class [Срок оценки: 30 days, 6 Months, 12 Months, annual for five years]
• 6 minutes walk distance [Срок оценки: 1 month, 6 months,12 Months]
• Kansas City Cardiomyopathy Questionnaire [Срок оценки: 30 days, 6 Months, 12 Months]

Критерии участия

Критерии включения

• Aged 60 or older, regardless of gender;
• Patients with moderate-severe or worse tricuspid regurgitation (TR≥3+);
• The multidisciplinary cardiac team (composed of experts in cardiovascular internal medicine and surgery, imaging, anesthesiology, etc. \[No. of experts in cardiovascular surgery >=2\]) considers the subjects to be at high risk for surgical operation (STS score > 6.0%) and expects that they will benefit from the transcatheter tricuspid annulus repair;
• Patient with normal left ventricular function (LVEF≥40%);
• The subject voluntarily participates in the clinical trial and he/she (or his/her guardian) agrees to sign the informed consent form.

Критерии исключения

• Patients with pulmonary artery systolic pressure ≥55 mmHg;
• Patients who have a prosthetic valve or annuloplasty ring at tricuspid valve, or who underwent tricuspid valve-related treatment procedure in the past;
• Evidence of lumps, thrombus or vegetation in the heart, jugular vein, or superior vena cava;
• Patients with moderate or worse aortic valve stenosis, mitral stenosis, aortic regurgitation or mitral regurgitation;
• Patients with severe uncontrolled hypertension (systolic blood pressure ≥180 mmHg and/or diastolic blood pressure ≥110 mmHg);
• Received PCI less than 1 month ago;
• MI happened or UAP was found less than 1 month ago;
• CVA occurred less than 3 months ago;
• Patients with comorbid active endocarditis or active RHD;
• Patients with coagulation disorder, hypercoagulable state or anemia (HGB < 90 g/L);
• Patients with acute infection or other severe infections;
• Patients with active peptic ulcer or active gastrointestinal bleeding;
• Patients with severe end-stage diseases (e.g., malignant tumors, severe pulmonary diseases, hepatic diseases, renal failure) whose life expectancy is less than 1 year;
• Patients with known allergies or contraindications to the raw materials of trial product or the drugs (e.g., antiplatelet drugs, anticoagulant drugs);
• People who are addicted to alcohol, drugs or narcotics;
• Patients with cognitive impairment who cannot cooperate with the study or follow-up;
• Those with a history of epilepsy or mental illness;
• Participated in any other clinical trials (except for registry studies) less than 30 days before the signing the informed consent form;
• Other situations that the investigator considers inappropriate for participation in this clinical trial.

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

• Shanghai Huihe Healthcare Tecnology Co.,Ltd. — Шанхай

Идентификаторы

NCT: NCT05434507 · HH2021002

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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