Feasibility Study of Treating Tricuspid Regurgitation With K-ClipTM Transcatheter
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Success rate 1year after operation
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Success rate 1year after operation
时间窗: 1-year after operation
Success rate of device implantation
时间窗: intra-procedure
Success rate of operation
时间窗: intra-procedure
6 minutes walk distance
时间窗: 1 month, 6 months,12 Months
Increase in distance (m) from baseline
NYHA Functional Class
时间窗: 30 days, 6 Months, 12 Months, annual for five years
Number of patients with improvement in NYHA class
Change of Tricuspid Regurgitation Grade
时间窗: 30 days, 6 Months, 12 Months, annual for five years
Number of patients with reduction in TR from baseline
Kansas City Cardiomyopathy Questionnaire
时间窗: 30 days, 6 Months, 12 Months
Number of points of improvement in health status as measured by Kansas City Cardiomyopathy Questionnaire
Change in echocardiographic parameters
时间窗: 30 days, 6 Months, 12 Months, annual for five years
Tricuspid annulus perimeter（mm）
次要结局
未报告次要终点