Treatment of Severe Secondary TRIcuspid Regurgitation in Patients With Advance Heart Failure With CAval Vein Implantation of the Edwards Sapien XT VALve
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- Maximum relative VO2 uptake
研究概览
简要总结
The purpose of this study is to assess the efficacy and safety of implanting an Edwards Sapien XT Valve into the vena cava inferior (VCI; between right atrium and the hepatic vein) on clinical variables, exercise tolerance and well being in patients with severe tricuspid regurgitation and signs of right heart failure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Severe symptomatic tricuspid regurgitation with a significant regurgitation jet into the caval and hepatic veins
- •Optimal medical treatment
- •High surgical risk with STS Score ≥ 10 or logistic EuroSCORE I ≥ 15 or any contraindication for conventional valve replacement/repair
- •NYHA class of at least II
- •Written informed consent
排除标准
- •VCI diameter > 32 mm
- •Severe left ventricular dysfunction with LVEF < 30%
- •Severe mitral insufficiency
- •Estimated life expectancy < 12months (360 days) due to carcinoma, chronic liver disease, chronic renal disease or chronic end stage pulmonary disease
- •Evidence of an acute myocardial infarction ≤ 1 month before the intended treatment
- •Evidence of stroke / TIA during the last 180 days
- •Leukopenia (WBC < 3000 cell/mL), anemia (Hgb < 9 g/dL), Thrombocytopenia (Plt < 50,000 cells/mL), or any known blood clotting disorder
- •Evidence of an intracardiac mass, thrombus or vegetation
- •Active upper GI bleeding within 1 month (30 days) prior to procedure
- •Patients with an acute emergency
- •Contraindication or hypersensitivity to all anticoagulation regimens, or inability to be anticoagulated for the study procedure
- •Allergy against the use of implanted stent / prosthesis
- •Patient undergoing regular dialysis or a serum creatinine above 3.0 mg/dl
- •Patients unsuitable for implantation because of thrombosis of the lower venous system or vena cava filter
- •Active bacterial endocarditis within 6 months (180 days) of procedure.
- •Women of childbearing potential without highly effective contraception (PEARL-Index < 1%)
- •Inability to comply with all of the study procedures and follow-up visits
- •Subjects who are legally detained in an official institute (according to § 20 MPG)
研究组 & 干预措施
Group A
Transfemoral implantation of an Edwards Sapien XT Valve into the vena cava inferior (VCI). For better stability and for downsizing of the VCI diameter the valve will be implanted after preparation of a landing zone. This includes implantation of one or two self expandable stents into the VCI prior to the final deployment of the valve.
干预措施: Edwards Sapien XT Valve (Device)
Group B
Control group (no surgery) with optimal medical treatment.
结局指标
主要结局
Maximum relative VO2 uptake
时间窗: at 3 month
we consider the difference of means in maximum relative VO2 uptake at 3 months compared to control group.
次要结局
- ejection fraction (EF)(day 30 and month 3)
- right ventricular (RV) diameter(day 30 and month 3)
- right atrial (RA) diameter(day 30 and month 3)
- hepatic vein diameter(day 30 and month 3)
- N-terminal pro Brain Natriuretic Peptide (NT-proBNP)(day 30 and month 3)
- tricuspid regurgitation jet velocity time integral (as assessed by Doppler echocardiography)(day 30 and month 3)
- aerobic threshold (assessed by spiroergometry)(day 30 and month 3)
- ventilation efficiency (as assessed by the VE / VCO2 slope in spiroergometry)(day 30 and month 3)
- Unscheduled rehospitalization(day 30 and month 3)
- Dyspnoea VAS(day 30 and month 3)
- Minnesota Living with Heart Failure Questionnaire(day 30 and month 3)
- NYHA class(day 30 and month 3)
- 6-minutes walk test(day 30 and month 3)
研究者
Prof. Dr. med. Karl Stangl
Prof. Dr. med Karl Stangl
Charite University, Berlin, Germany