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

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.

Study Overview

• Status: Recruiting
• Conditions: Tricuspid Valve Regurgitation
• Intervention / Treatment: Device: Tricuspid Valve Replacement System via jugular vein

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Fan Qiao, MD; Phone Number: +8613564620805; Email: qiaofan@smmu.edu.cn
• Study Contact Backup: Name: Fan Yang, MD; Phone Number: +8618321785183; Email: dearyangf@126.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100029
      • Not yet recruiting
      • Beijing Anzhen Hospital
      • Contact: Xu Meng, MD.; Phone Number: 010-64456260; Email: mxu@263.net
    • Beijing, Beijing, China, 100037
      • Not yet recruiting
      • Fu Wai Hospital
      • Contact: Xiangbin Pan, MD.; Phone Number: 010-68314466; Email: xiangbin428@hotmail.com
  • Guangdong
    • Guangzhou, Guangdong, China, 510000
      • Not yet recruiting
      • Guangdong Provincial People's Hospital
      • Contact: Huiming Guo, MD.; Email: guohuiming@vip.tom.com
  • Hubei
    • Wuhan, Hubei, China, 430000
      • Not yet recruiting
      • Wuhan Union Hospital
      • Contact: Nianguo Dong, MD.; Email: ng_dong@163.com
  • Shaanxi
    • Xi'an, Shaanxi, China, 710000
      • Not yet recruiting
      • Xijing Hospital
      • Contact: Jian Yang, MD.; Email: yangjian1212@hotmail.com
      • Contact: Shiqiang Yu, MD.; Email: yushiq@fmmu.edu.cn
  • Shanghai
    • Shanghai, Shanghai, China, 200433
      • Recruiting
      • Changhai Hospital
      • Contact: Zhiyun Xu, MD.; Phone Number: 021-31166666; Email: zhiyunx@smmu.edu.cn
    • Shanghai, Shanghai, China
      • Recruiting
      • Shanghai Zhongshan Hospital
      • Contact: Junbo Ge, MD
  • Sichuan
    • Chengdu, Sichuan, China, 610000
      • Not yet recruiting
      • West China Hospital
      • Contact: Yingqiang Guo, MD.; Phone Number: +86 028 85421833
      • Contact: Mao Chen, MD.; Email: hmaochen@vip.sina.com
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310000
      • Not yet recruiting
      • the Second Affiliated Hospital Zhejiang University School of Medicine
      • Contact: Jianan Wang, MD.; Email: wangjianan111@zju.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 ΔP≥ 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tricuspid Valve Replacement System via jugular vein; Subjects who received transcatheter tricuspid valve replacement with LuX-Valve and delivery system via jugular vein will be included in this arm.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Death	All-cause Death	1 year
Tricuspid Regurgitation Reduction	Tricuspid regurgitation measured with echocardiography in core lab reduces at least 2 grades.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
Major Adverse Event (MAE)	MAE includes death, myocardial infarction, stroke, reoperation for bleeding, renal failure, pulmonary embolism, gastrointestinal hemorrhage, rehospitalization.	1 year
Major Adverse Event (MAE)	MAE includes death, myocardial infarction, stroke, reoperation for bleeding, renal failure, pulmonary embolism, gastrointestinal hemorrhage, rehospitalization.	2 year
Major Adverse Event (MAE)	MAE includes death, myocardial infarction, stroke, reoperation for bleeding, renal failure, pulmonary embolism, gastrointestinal hemorrhage, rehospitalization.	3 year
Major Adverse Event (MAE)	MAE includes death, myocardial infarction, stroke, reoperation for bleeding, renal failure, pulmonary embolism, gastrointestinal hemorrhage, rehospitalization.	4 year
Major Adverse Event (MAE)	MAE includes death, myocardial infarction, stroke, reoperation for bleeding, renal failure, pulmonary embolism, gastrointestinal hemorrhage, rehospitalization.	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.	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.	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.	1 year

Collaborators and Investigators

• Sponsor: Changhai Hospital
• Collaborators: Xijing Hospital; Shanghai Zhongshan Hospital; West China Hospital; Second Affiliated Hospital, School of Medicine, Zhejiang University; Guangdong Provincial People's Hospital; Beijing Anzhen Hospital; Wuhan Union Hospital, China; Fu Wai Hospital, Beijing, China
• Investigators: Principal Investigator: Shengshou Hu, MD, Fuwai Hospital; Principal Investigator: Zhiyun Xu, MD, Changhai Hospital; Study Director: Fanglin Lu, MD, Changhai Hospital; Principal Investigator: Junbo Ge, MD, Shanghai Zhongshan Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2022
• Primary Completion (Anticipated): March 1, 2027
• Study Completion (Anticipated): March 1, 2027

Study Registration Dates

• First Submitted: December 28, 2021
• First Submitted That Met QC Criteria: December 28, 2021
• First Posted (Actual): January 18, 2022

Study Record Updates

• Last Update Posted (Actual): January 18, 2022
• Last Update Submitted That Met QC Criteria: December 28, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: Tricuspid valve regurgitation; LuX-Valve; Transcatheter tricuspid valve replacement
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Valve Diseases; Tricuspid Valve Insufficiency
• Other Study ID Numbers: TRAVEL II

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No