THE TRAVEL II TRIAL: Transcatheter Right Atrial-ventricular Valve rEplacement With LuX-Valve Via Jugular Vein

Tricuspid Valve Regurgitation Clinical Trial

Official title:

THE TRAVEL II TRIAL: Transcatheter Right Atrial-ventricular Valve rEplacement With LuX-Valve Via Jugular Vein

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05194423
• Other study ID #: TRAVEL II
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2022
• Est. completion date: March 2027

Study information

• Verified date: December 2021
• Source: Changhai Hospital
• Contact: Fan Qiao, MD
• Phone: +8613564620805
• Email: qiaofan[@]smmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: March 2027
• Est. primary completion date: March 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

1. Age = 50 years at time of consent.

2. Subjects or subject's legal representative has been informed of the nature of the study and provided written informed consent.

3. 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.

4. Subjects must guarantee they won't participate in any other clinical trial for a period of one year after the intervention.

5. Subjects are with New York Heart Association (NYHA) Functional Class III or IV.

6. Subjects are with normal left heart function (EF = 50%).

7. No indications for left-sided or pulmonary valve intervention.

8. 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).

Exclusion Criteria:

1. Subjects with pulmonary hypertension (systolic pressure = 55mmHg determined by right heart catheterization).

2. Subjects with previous transcatheter or surgical tricuspid valve procedure.

3. Subjects with tricuspid stenosis or other anatomy disorders that unsuitable for the procedure.

4. Subjects with depressed right heart function (tricuspid annular plane systolic excursion (TAPSE) < 10mm or right ventricle fractional area change (FAC) < 20%).

5. Subjects with aortic stenosis (mean ?P= 40mmHg or aortic valve area = 1 cm2), aortic regurgitation (= 3+), mitral stenosis (mitral valve area =1.5 cm2) or mitral regurgitation (= 3+).

6. Subjects with active endocarditis or other infectious diseases.

7. Subjects with untreated severe coronary artery disease.

8. Subjects with percutaneous coronary intervention, cerebrovascular accident or surgical intervention within 3 months of the date of the procedure.

9. Subjects with coagulation disorders.

10. Subjects with known allergy, hypersensitivity or contraindication to the material or drugs used in the procedure.

11. Subjects with cognitive disorders that can not cooperate the study or follow-up.

12. Subjects with less than 12 months life expectancy because of non-cardiac conditions.

Related Conditions & MeSH terms

• Tricuspid Valve Insufficiency
• Tricuspid Valve Regurgitation

Intervention

Device:
• Tricuspid Valve Replacement System via jugular vein
To eliminate the tricuspid regurgitation through orthotopically replacing tricuspid valve with LuX-Valve system via jugular vein.

Locations

Country	Name	City	State
China	Beijing Anzhen Hospital	Beijing	Beijing
China	Fu Wai Hospital	Beijing	Beijing
China	West China Hospital	Chengdu	Sichuan
China	Guangdong Provincial People's Hospital	Guangzhou	Guangdong
China	The Second Affiliated Hospital Zhejiang University School of Medicine	Hangzhou	Zhejiang
China	Changhai Hospital	Shanghai	Shanghai
China	Shanghai Zhongshan Hospital	Shanghai	Shanghai
China	Wuhan Union Hospital	Wuhan	Hubei
China	Xijing Hospital	Xi'an	Shaanxi

Sponsors (9)

Lead Sponsor	Collaborator
Changhai Hospital	Beijing Anzhen Hospital, Fu Wai Hospital, Beijing, China, Guangdong Provincial People's Hospital, Second Affiliated Hospital, School of Medicine, Zhejiang University, Shanghai Zhongshan Hospital, West China Hospital, Wuhan Union Hospital, China, Xijing Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Death	All-cause Death	1 year
Primary	Tricuspid Regurgitation Reduction	Tricuspid regurgitation measured with echocardiography in core lab reduces at least 2 grades.	1 year
Secondary	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.	1 year
Secondary	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.	2 year
Secondary	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.	3 year
Secondary	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.	4 year
Secondary	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.	5 year
Secondary	Major Adverse Event (MAE)	MAE includes death, myocardial infarction, stroke, reoperation for bleeding, renal failure, pulmonary embolism, gastrointestinal hemorrhage, rehospitalization.	1 year
Secondary	Major Adverse Event (MAE)	MAE includes death, myocardial infarction, stroke, reoperation for bleeding, renal failure, pulmonary embolism, gastrointestinal hemorrhage, rehospitalization.	2 year
Secondary	Major Adverse Event (MAE)	MAE includes death, myocardial infarction, stroke, reoperation for bleeding, renal failure, pulmonary embolism, gastrointestinal hemorrhage, rehospitalization.	3 year
Secondary	Major Adverse Event (MAE)	MAE includes death, myocardial infarction, stroke, reoperation for bleeding, renal failure, pulmonary embolism, gastrointestinal hemorrhage, rehospitalization.	4 year
Secondary	Major Adverse Event (MAE)	MAE includes death, myocardial infarction, stroke, reoperation for bleeding, renal failure, pulmonary embolism, gastrointestinal hemorrhage, rehospitalization.	5 year
Secondary	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.	1 year
Secondary	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.	1 year
Secondary	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.	1 year