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.
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 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%).
Single group
Tricuspid Valve Replacement System
DeviceTo eliminate the tricuspid regurgitation through orthotopically replacing tricuspid valve with LuX-Valve system.
Death
All-cause Death
Tricuspid Regurgitation Reduction
Tricuspid regurgitation measured with echocardiography in core lab reduces at least 2 grades.
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.
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.
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.
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.
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Changhai Hospital
Lead sponsor
Fu Wai Hospital, Beijing, China
Collaborator
Beijing Anzhen Hospital
Collaborator
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Collaborator
West China Hospital
Collaborator
Xijing Hospital
Collaborator
Guangdong Provincial People's Hospital
Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborator
