NCT05913908招募中不适用
Early Feasibility Study of the DUO Transcatheter Tricuspid Coaptation Valve System in Patients With Tricuspid Regurgitation
CroiValve Limited32 个研究点 分布在 2 个国家目标入组 15 人开始时间: 2024年8月13日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 15
- 试验地点
- 32
- 主要终点
- Freedom from device or procedure related MAEs
研究概览
简要总结
The study is an early feasibility study to measure individual patient clinical outcomes and effectiveness, evaluate the safety and function of the DUO Transcatheter Tricuspid Coaptation Valve System (DUO System).
详细描述
Multi-center, prospective, non-randomized, investigational, and pre-market. Data collected in this clinical study will include safety and function of the investigational system as well as up to 5 year clinical outcomes.
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
- •Presence of severe or greater tricuspid regurgitation as determined by the Echo Core Lab.
- •Patient is symptomatic despite medical therapy.
- •The local Site Heart Team determines the Patient is appropriate for transcatheter valve intervention.
- •The Patient's anatomy is suitable in the judgment of the Patient Selection Committee.
- •Age ≥18 years
- •The Patient has been informed of the nature of the study and agrees to its provisions and has provided written Informed Consent.
排除标准
- •Patient is currently participating in another clinical investigation that could affect the outcome of this trial.
- •Any previous tricuspid valve intervention that would interfere with the placement of the investigational device.
- •Moderate or greater tricuspid valve stenosis.
- •Severe aortic, mitral and/or pulmonic valve stenosis and/or regurgitation
- •Pacemaker or implantable cardioverter-defibrillator (ICD) leads that would prevent appropriate placement of the investigational device.
- •Need for concomitant surgical or interventional procedure, known at the time of screening (e.g., CABG, Atrial Septal Defect (ASD) repair).
- •Ejection Fraction (EF) <25%
- •Echocardiographic evidence of unstable intracardiac mass, thrombus or vegetation
- •Patient has Systolic Pulmonary Pressure (sPAP) >60 mm Hg
- •Severe hemodynamic instability: cardiogenic shock or the need for inotropic support or Intra-Aortic Balloon Pump (IABP) or other percutaneous ventricular assist devices
- •Severe respiratory instability with continuous use of home oxygen
- •Severe right ventricular dysfunction
- •Untreated clinically significant coronary or carotid artery disease requiring revascularization surgical or interventional PCI.
- •Stroke or transient ischemic event within 90 days prior to the index procedure
- •Acute myocardial infarction within 30 days before the index procedure
- •Renal insufficiency (eGFR <25 ml/min) or currently on chronic dialysis
- •Active endocarditis within 6 months of the index procedure
- •Pulmonary embolism or deep vein thrombosis within the last 6 months
- •Any surgical, interventional, or transcatheter procedure within 30 days prior to the index procedure
- •Hypertrophic cardiomyopathy, restrictive cardiomyopathy or constrictive pericarditis
- •Life expectancy <1 year
- •Active infections requiring current antibiotic therapy
- •Known severe liver disease
- •Is on the waiting list for a transplant or has had a prior heart or lung transplant
- •Known active peptic ulcer or active GI bleed
- •Unable to take anticoagulant therapy
- •Any known major coagulation abnormalities, thrombocytopenia, platelets < 50,000/ml or severe anemia Hb <8 g/dl
- •Known patient is actively abusing drugs
- •Any known sensitivities or allergies to contrast (that cannot be adequately premedicated) and/or the device materials, including nickel and titanium
- •Patients who are pregnant or intend to become pregnant
- •Any condition making it unlikely the Patient will be able to complete all protocol procedures (including compliance with optimal medical therapy and immobility that would prevent completion of 6MWT), follow-up visits, or impact the scientific soundness of the clinical investigation result
研究组 & 干预措施
Treatment
Experimental
Treatment with the DUO Transcatheter Tricuspid Coaptation Valve System (DUO System)
干预措施: DUO Transcatheter Tricuspid Coaptation Valve System (Device)
结局指标
主要结局
Freedom from device or procedure related MAEs
时间窗: At 30 days
* Death * Reintervention * Disabling stroke * Myocardial infarction * Major access site and vascular complications * Severe bleeding * Renal failure requiring dialysis * Major cardiac structural complications * Pulmonary embolism
次要结局
未报告次要终点
研究者
研究点 (32)
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