NCT04936802Unknown不适用
Safety and Feasibility of the Transcatheter Tricuspid Valve Repair System (Trialign) for the Treatment or Reduction of Moderate to Severe Functional Tricuspid Regurgitation
Xijing Hospital0 个研究点目标入组 5 人开始时间: 2021年6月25日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 5
- 主要终点
- Severe adverse device events (SADE)
研究概览
简要总结
The purpose of the study is to demonstrate safety and feasibility of the transcatheter tricuspid valve repair system (Trialign) for the treatment or reduction of moderate to severe functional tricuspid regurgitation.
详细描述
This study is a prospective single-arm trial for transcatheter tricuspid valve repair system (Trialign). A series of physical, imaging and laboratory exams will be performed to determine whether a subject has moderate to severe tricuspid regurgitation with high surgical risk. Subjects who meet the criteria will then receiveTrialign treatment if an informed consent is obtained.
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
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects has been informed the study and provided written informed consent.
- •Age ≥ 18 and ≤ 85 years old.
- •NYHA class II, III or ambulatory IV.
- •The subject was diagnosed moderate to severe functional tricuspid regurgitation
- •The subject was at high risk for open heart valve surgery. The heart team recommended tricuspid annuloplasty.
- •Subjects shall meet all selected criteria for TEE with moderate or severe tricuspid regurgitation.
- •Systolic pulmonary artery pressure (SPAP) ≤ 60mmHg.
- •Left ventricular ejection fraction (LVEF) ≥ 30%.
- •Right ventricle tricuspid annular plane systolic excursion (TAPSE) ≥ 15 mm.
- •Tricuspid valve annular diameter ≤ 55 mm.
- •Tricuspid EROA ≤ 1.75 cm
- •Functional tricuspid valve regurgitation pathology with a structurally normal valve.
- •Sufficient posterior annular dimension for device implantation.
排除标准
- •Severe uncontrolled hypertension (SBP ≥ 180 mmHg and/or DBP ≥ 110 mmHg).
- •History of heart transplant.
- •Previous tricuspid valve repair or replacement (including artificial valve).
- •Presence of a left ventricular assist device.
- •Active endocarditis.
- •Severe degenerative tricuspid valve disease.
- •Severe aortic stenosis.
- •The degree of mitral regurgitation is greater than grade
- •Complete occlusion due to chronic calcification of the right coronary artery.
- •History of right internal jugular vein occlusion or thrombosis;
- •Anatomy in the region of the access path (right internal jugular vein) prevented correct placement of a percutaneous tricuspid valve annuloplasty system (e.g.: the presence of spinal stenosis, stent, vascular prosthesis).
- •An indication of the presence of thrombi in the right ventricle or atrium.
- •Myocardial infarction (MI) or known unstable angina within the 30 days prior to the index procedure.
- •Any percutaneous coronary intervention (PCI) within 30 days prior to the index procedure or planned 3 months post-the index procedure.
- •Hemodynamic instability or cardiogenic shock.
- •Restrictive or hypertrophic cardiomyopathy. Constructive pericarditis, or other structural heart disease.
- •Cerebrovascular accident (CVA) within the past 6 months
- •Serum creatinine > 2.5 mg/dL (or 221 μmol/L), Impaired kidney function, defined as glomerular filtration rate (GFR) of 30 mL/min or less.
- •Anemia (hemoglobin <<90g/L) not corrected by transfusion. Thrombocytopenia (platelet count <100×109/L) or thrombocytosis (>750×109/L).
- •Bleeding disorders or hypercoagulable state.
- •Active peptic ulcer or active gastrointestinal bleeding.
- •Contraindication to anticoagulant or antiplatelet therapies.
- •Contraindications to or refusal of blood transfusions.
- •Known allergy to stainless steel, nickel, platinum iridium, polyester and/or silk.
- •Pregnant or lactating; or female of childbearing potential with a positive pregnancy test 24 hours before any study-related radiation exposure.
- •Life expectancy less than 12 months.
- •Concurrent use of another clinical study product or use of another clinical study product within 30 days prior to enrolment.
- •Other circumstances deemed unsuitable for inclusion by the researcher.
结局指标
主要结局
Severe adverse device events (SADE)
时间窗: 30 days
Severe adverse device events (SADE) , defined as any device related complication, including but not limited to: death, myocardial infarction, stroke, reoperation, renal failure, pulmonary embolism, gastrointestinal bleeding, readmission, etc.
次要结局
- 6-minute walk test (6MWT)(6 months)
- Technical success(30 days)
- New York Heart Association (NYHA) classification(6 months)
- EuroQol five dimensions questionnaire (EQ-5D)(6 months)
- Evaluation of tricuspid valve function(6 months)
- Incidence of adverse events(6 months)
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