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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
150
To eliminate the tricuspid regurgitation through orthotopically replacing tricuspid valve with LuX-Valve system.
Beijing Anzhen Hospital
Beijing, Beijing Municipality, China
RECRUITINGFu Wai Hospital
Beijing, Beijing Municipality, China
RECRUITINGGuangdong Provincial People's Hospital
Guangzhou, Guangdong, China
Death
All-cause Death
Time frame: 1 Year
Tricuspid Regurgitation Reduction
Tricuspid regurgitation measured with echocardiography in core lab reduces at least 2 grades.
Time frame: 1 Year
Device or Procedure-Related Adverse Events
Device related mortality, device malposition, right ventricular outflow tract obstruction, conduction system disturbances, new onset shunt across ventricular septum, coronary artery injury, valve failure, convert to open surgery, reintervention, embolization.
Time frame: 1 Year
Device or Procedure-Related Adverse Events
Device related mortality, device malposition, right ventricular outflow tract obstruction, conduction system disturbances, new onset shunt across ventricular septum, coronary artery injury, valve failure, convert to open surgery, reintervention, embolization.
Time frame: 2 Year
Device or Procedure-Related Adverse Events
Device related mortality, device malposition, right ventricular outflow tract obstruction, conduction system disturbances, new onset shunt across ventricular septum, coronary artery injury, valve failure, convert to open surgery, reintervention, embolization.
Time frame: 3 Year
Device or Procedure-Related Adverse Events
Device related mortality, device malposition, right ventricular outflow tract obstruction, conduction system disturbances, new onset shunt across ventricular septum, coronary artery injury, valve failure, convert to open surgery, reintervention, embolization.
Time frame: 4 Year
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Wuhan Union Hospital
Wuhan, Hubei, China
RECRUITINGXijing Hospital
Xi'an, Shaanxi, China
RECRUITINGChanghai Hospital
Shanghai, Shanghai Municipality, China
RECRUITINGWest China Hospital
Chengdu, Sichuan, China
RECRUITINGThe Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
RECRUITINGDevice or Procedure-Related Adverse Events
Device related mortality, device malposition, right ventricular outflow tract obstruction, conduction system disturbances, new onset shunt across ventricular septum, coronary artery injury, valve failure, convert to open surgery, reintervention, embolization.
Time frame: 5 Year
Major Adverse Event (MAE)
MAE includes death, myocardial infarction, stroke, reoperation for bleeding, renal failure, pulmonary embolism, gastrointestinal hemorrhage, rehospitalization.
Time frame: 1 Year
Major Adverse Event (MAE)
MAE includes death, myocardial infarction, stroke, reoperation for bleeding, renal failure, pulmonary embolism, gastrointestinal hemorrhage, rehospitalization.
Time frame: 2 Year
Major Adverse Event (MAE)
MAE includes death, myocardial infarction, stroke, reoperation for bleeding, renal failure, pulmonary embolism, gastrointestinal hemorrhage, rehospitalization.
Time frame: 3 Year
Major Adverse Event (MAE)
MAE includes death, myocardial infarction, stroke, reoperation for bleeding, renal failure, pulmonary embolism, gastrointestinal hemorrhage, rehospitalization.
Time frame: 4 Year
Major Adverse Event (MAE)
MAE includes death, myocardial infarction, stroke, reoperation for bleeding, renal failure, pulmonary embolism, gastrointestinal hemorrhage, rehospitalization.
Time frame: 5 Year
Functional Change in New York Heart Association (NYHA) Classification
Subjects' heart function is ranged from NYHA I to IV based on how much a patient is limited during physical activity. NYHA I means no limited on physical activity while NYHA IV means unable to take any physical activity.
Time frame: 1 Year
Change in Quality of Life (QOL) is evaluated with Kansas City Cardiomyopathy (KCCQ)
KCCQ score ranges from 0 to 100, which 0 reflects the worst health status and 100 reflects the best health status.
Time frame: 1 Year
Change in Quality of Life (QOL) is evaluated with Six Minute Walk Test (6MWT)
6MWT distance is recorded and compared with baseline during follow-up.
Time frame: 1 Year