TRI-REPAIR: TrIcuspid Regurgitation RePAIr With CaRdioband Transcatheter System
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 11
- 主要终点
- Major Serious Adverse Events (MSAEs) and Serious Adverse Device Effects (SADE)
研究概览
简要总结
The current management of tricuspid regurgitation (TR) is either conservative (by medication) or by surgery, usually in concomitant with other valves repair or replacement. TR can worsen or appear late after successful mitral valve surgery which portends a poor prognosis. However, standard surgical approaches requiring cardiopulmonary bypass and especially second surgery have an excessive risks. Thus many patients are denied surgery because of unfavorable risk-benefit balance. Therefore there is a need for novel devices enabling interventional cardiologists and cardiothoracic surgeons to perform tricuspid annuloplasty by transcatheter methods. Cardioband replicates established surgical techniques (e.g., annuloplasty) using transfemoral approach, without sutures and with adjusted on the beating heart. Similar to the approved indication for mitral annuloplasty. The Cardioband System is expected to allow for treatment of patients that would otherwise not undergo Tricuspid valve repair due to the invasiveness of current techniques.
详细描述
The Cardioband Transcatheter System (Cardioband) is a marketed system that was approved for treatment of secondary (functional) mitral regurgitation (FMR) (CE granted on September 2015). The Cardioband is an annuloplasty band that is similar to a surgical annuloplasty, however deployed on the beating heart through a transvenous approach. The CE mark study with 30 subjects has been completed and documented significant reduction of severity of MR and improvement in quality of life by Minnesota living with heart failure questionnaire (MLHFQ), New York Heart Association (NYHA) and 6- minute walk test (6MWT), in subjects with moderate to severe MR. The aim of the current study is to evaluate the Cardioband annuloplasty system for repair the 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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic functional tricuspid regurgitation (FTR) with annular diameter ≥ 40 mm with valve Systolic pulmonary pressure (sPAP) ≤ 60mmHg
- •≥18 years old
- •New York Heart Association (NYHA) Class II-IVa
- •Symptomatic despite Guideline Directed Medical Therapy (GDMT); at minimum patient on diuretic regimen
- •Patient is willing and able to comply with all specified study evaluations
- •The Local Site Heart Team concur that surgery will not be offered as a treatment option
- •Transfemoral access of the Cardioband is determined to be feasible
排除标准
- •Aortic, mitral and/or pulmonic valve stenosis and/or regurgitation ≥ moderate
- •Severe uncontrolled hypertension (Systolic BP ≥ 180 mmHg and/or Diastolic BP ≥ 110 mm Hg)
- •Previous tricuspid valve repair or replacement
- •Trans-tricuspid pacemaker or defibrillator leads suggesting impingement of the of the tricuspid valve leaflets, as evaluated by echocardiography
- •Active endocarditis
- •MI or known unstable angina within the 30 days prior to the index procedure
- •Any percutaneous coronary intervention (PCI) or transcatheter valvular intervention within 30 days prior to the index
- •Hemodynamic instability or on IV inotropes
- •Cerebrovascular Accident (CVA) within the past 6 months
- •Subject is on chronic dialysis
- •Anemia (Hb < 9 g/dL) not corrected by transfusion
- •Bleeding disorders or hypercoaguable state
- •Active peptic ulcer or active gastrointestinal (GI) bleeding
- •Contraindication to anticoagulants
- •Known allergy to stainless steel, nickel, and/or polyester
- •Pregnant or lactating; or female of childbearing potential with a positive pregnancy test 24 hours before any study-related radiation exposure
- •In the judgment of the Investigator, co-morbid condition(s) that could limit the subject's ability to participate in the study, including compliance with follow-up requirements, or that could impact the scientific integrity of the study
- •Life expectancy of less than 12 months
- •Impaired judgment and/or is undergoing emergency treatment
- •Currently participating in another investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the endpoints of this study
- •intra-cardiac masses, thrombi or vegetations
- •Patients with cardiac cachexia
- •Subjects in whom transesophageal echocardiography is contraindicated
- •. Known hypersensitivity or contraindication to procedural medications which cannot be adequately managed medically
- •Untreated clinically significant CAD requiring revascularization
- •Echocardiographic evidence of severe right ventricular dysfunction
- •Any coronary or endovascular surgery, within 3 months prior to procedure
结局指标
主要结局
Major Serious Adverse Events (MSAEs) and Serious Adverse Device Effects (SADE)
时间窗: 30 days
Overall rate of Major Serious Adverse Events (MSAEs)\* and serious adverse device effects (SADE)
Access, Deployment and Positioning of the Cardioband Device
时间窗: Intra-procedure
Successful access, deployment and positioning of the Cardioband device
次要结局
- Effective Regurgitant Orifice Area (EROA) [Full Analysis Data Set](1, 6, 12, and 24 months over baseline)
- Regurgitant Volume [Full Analysis Data Set](1, 6, 12, and 24 months over baseline)
- TAPSE [Paired Baseline and Follow-Up](1, 6, 12, and 24 months over baseline)
- NYHA [Paired Baseline and Follow-Up](1, 6, 12, and 24 months over baseline)
- Technical Success(1, 6, 12, and 24 months)
- Tricuspid Regurgitation [Paired Baseline and Follow-Up](1, 6, 12, and 24 months over baseline)
- 6MWT [Paired Baseline and Follow-Up](1, 6, 12, and 24 months over baseline)
- Bilirubin [Full Analysis Data Set](1, 6, 12, and 24 months over baseline)
- Tricuspid Regurgitation [Full Analysis Data Set](1, 6, 12, and 24 months over baseline)
- Effective Regurgitant Orifice Area (EROA) [Paired Baseline and Follow-Up](1, 6, 12, and 24 months over baseline)
- Left Ventricle End Systolic Volume Index (LVESVI) [Full Analysis Data Set](1, 6, 12, and 24 months over baseline)
- Glutamic Oxaloacetic Transaminase (GOT) Aspartate Transaminase (AST) [Full Analysis Data Set](1, 6, 12, and 24 months over baseline)
- Regurgitant Volume [Paired Baseline and Follow-Up](1, 6, 12, and 24 months over baseline)
- TAPSE [Full Analysis Data Set](1, 6, 12, and 24 months over baseline)
- 6MWT [Full Analysis Data Set](1, 6, 12, and 24 months over baseline)
- Kansas City Cardiomyopathy (KCCQ) [Paired Baseline and Follow-Up](1, 6, 12, and 24 months over baseline)
- Left Ventricle Ejection Fraction (LVEF) [Paired Baseline and Follow-Up](1, 6, 12, and 24 months over baseline)
- Left Ventricle End Diastolic Volume Index (LVEDVI) [Full Analysis Data Set](1, 6, 12, and 24 months over baseline)
- Glutamic Pyruvic Transaminase (GPT) Alanine Transaminase (ALT) [Full Analysis Data Set](1, 6, 12, and 24 months over baseline)
- NYHA [Full Analysis Data Set](1, 6, 12, and 24 months over baseline)
- Kansas City Cardiomyopathy (KCCQ) [Full Analysis Data Set](1, 6, 12, and 24 months over baseline)
- Left Ventricle Ejection Fraction (LVEF) [Full Analysis Data Set](1, 6, 12, and 24 months over baseline)
- NT-pro BNP [Full Analysis Data Set](1, 6, 12, and 24 months over baseline)
- Diuretic Therapy(1, 6, 12, and 24 months over baseline)
- Blood Urea Nitrogen (BUN), Serum Creatinine [Full Analysis Data Set](1, 6, 12, and 24 months over baseline)
- Activity by Wearable Device(1, 6, 12, and 24 months over baseline)