NCT05194423招募中不适用
THE TRAVEL II TRIAL: Transcatheter Right Atrial-ventricular Valve rEplacement With LuX-Valve Via Jugular Vein
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 9
- 主要终点
- Death
研究概览
简要总结
The trial aims to evaluate the safety and effectiveness of LuX-Valve transcatheter tricuspid valve and delivery system via jugular vein which are intended to use in symptomatic patients with severe tricuspid regurgitation and high surgical risk.
详细描述
The TRAVEL II study is a prospective multi-center single-arm trial for transcatheter tricuspid valve replacement with LuX-Valve via jugular vein. A series of physical, imaging and laboratory exams will be performed to determine whether a subject has severe tricuspid regurgitation with high surgical risk. Subjects who meet the criteria will then receive LuX-Valve implantation via jugular vein 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
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 50 years at time of consent.
- •Subjects or subject's legal representative has been informed of the nature of the study and provided written informed consent.
- •The site heart team confirmed the subject is at high risk for tricuspid valve surgery (euroSCORE II ≥ 7.0%) and the subject will get benefit from the intervention.
- •Subjects must guarantee they won't participate in any other clinical trial for a period of one year after the intervention.
- •Subjects are with New York Heart Association (NYHA) Functional Class III or IV.
- •Subjects are with normal left heart function (EF ≥ 50%).
- •No indications for left-sided or pulmonary valve intervention.
- •Subjects must have severe or greater tricuspid regurgitation ( the vena contracta (VC) width ≥ 7 mm or the effective regurgitant orifice area (EROA) ≥ 40 mm2), which confirmed by the Echocardiography Core Lab (ECL) via transthoracic echocardiogram (TTE).
排除标准
- •Subjects with pulmonary hypertension (systolic pressure ≥ 55mmHg determined by right heart catheterization).
- •Subjects with previous transcatheter or surgical tricuspid valve procedure.
- •Subjects with tricuspid stenosis or other anatomy disorders that unsuitable for the procedure.
- •Subjects with depressed right heart function (tricuspid annular plane systolic excursion (TAPSE) < 10mm or right ventricle fractional area change (FAC) < 20%).
- •Subjects with aortic stenosis (mean ΔP≥ 40mmHg or aortic valve area ≤ 1 cm2), aortic regurgitation (≥ 3+), mitral stenosis (mitral valve area ≤1.5 cm2) or mitral regurgitation (≥ 3+).
- •Subjects with active endocarditis or other infectious diseases.
- •Subjects with untreated severe coronary artery disease.
- •Subjects with percutaneous coronary intervention, cerebrovascular accident or surgical intervention within 3 months of the date of the procedure.
- •Subjects with coagulation disorders.
- •Subjects with known allergy, hypersensitivity or contraindication to the material or drugs used in the procedure.
- •Subjects with cognitive disorders that can not cooperate the study or follow-up.
- •Subjects with less than 12 months life expectancy because of non-cardiac conditions.
结局指标
主要结局
Death
时间窗: 1 year
All-cause Death
Tricuspid Regurgitation Reduction
时间窗: 1 year
Tricuspid regurgitation measured with echocardiography in core lab reduces at least 2 grades.
次要结局
- Change in Quality of Life (QOL) is evaluated with Six Minute Walk Test (6MWT)(1 year)
- Functional Change in New York Heart Association (NYHA) Classification(1 year)
- Device or Procedure-Related Adverse Events(5 year)
- Major Adverse Event (MAE)(5 year)
- Change in Quality of Life (QOL) is evaluated with Kansas City Cardiomyopathy (KCCQ)(1 year)
研究者
Zhiyun Xu
Chair of Department of Cardiovascular Surgery
Changhai Hospital
研究点 (9)
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