NCT04436653招募中不适用
THE TRAVEL TRIAL: Transcatheter Right Atrial-ventricular Valve rEplacement With LuX-Valve
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 8
- 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 which are intended to use in symptomatic patients with severe tricuspid regurgitation and high surgical risk.
详细描述
The TRAVEL study is a prospective multi-center single-arm trial for transcatheter tricuspid valve replacement with LuX-Valve. 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 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.
研究组 & 干预措施
Tricuspid Valve Replacement System
Experimental
Subjects who received transcatheter tricuspid valve replacement with LuX-Valve and delivery system will be included in this arm.
干预措施: Tricuspid Valve Replacement System (Device)
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)
- Major Adverse Event (MAE)(5 Year)
- Device or Procedure-Related Adverse Events(5 Year)
- Functional Change in New York Heart Association (NYHA) Classification(1 Year)
- Change in Quality of Life (QOL) is evaluated with Kansas City Cardiomyopathy (KCCQ)(1 Year)
- Device or Procedure-Related Adverse Events(1 Year)
- Device or Procedure-Related Adverse Events(2 Year)
- Device or Procedure-Related Adverse Events(3 Year)
- Device or Procedure-Related Adverse Events(4 Year)
- Major Adverse Event (MAE)(1 Year)
- Major Adverse Event (MAE)(2 Year)
- Major Adverse Event (MAE)(3 Year)
- Major Adverse Event (MAE)(4 Year)
研究者
Zhiyun Xu
Chair of Department of Cardiovascular Surgery
Changhai Hospital
研究点 (8)
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