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

• Sponsor: Changhai Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05194423
• Collaborator: Shanghai Zhongshan Hospital (Other), Fu Wai Hospital, Beijing, China (Other), Beijing Anzhen Hospital (Other), Wuhan Union Hospital, China (Other), West China Hospital (Other), Xijing Hospital (Other), Guangdong Provincial People's Hospital (Other), Second Affiliated Hospital, School of Medicine, Zhejiang University (Other)
• Enrollment: 150
• Locations: 9
• Arm: 1
• Anticipated Duration (Months): 60
• Patients Per Site: 16.7
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Tricuspid Valve Regurgitation	Device: Tricuspid Valve Replacement System via jugular vein	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 150 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: This is a prospective, multi-center single-arm trial in eight centers in China. A minimum of 150 subjects will be enrolled in this study and followed-up at discharge (≤ 10 days post operation), 30 days, 6 months, 1, 2, 3, 4, 5 years.This is a prospective, multi-center single-arm trial in eight centers in China. A minimum of 150 subjects will be enrolled in this study and followed-up at discharge (≤ 10 days post operation), 30 days, 6 months, 1, 2, 3, 4, 5 years.
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: THE TRAVEL II TRIAL: Transcatheter Right Atrial-ventricular Valve rEplacement With LuX-Valve Via Jugular Vein
• Anticipated Study Start Date: Mar 1, 2022
• Anticipated Primary Completion Date: Mar 1, 2027
• Anticipated Study Completion Date: Mar 1, 2027

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Death [1 year]

   All-cause Death

2. Tricuspid Regurgitation Reduction [1 year]

   Tricuspid regurgitation measured with echocardiography in core lab reduces at least 2 grades.

Secondary Outcome Measures

1. Device or Procedure-Related Adverse Events [1 year]

   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. Device or Procedure-Related Adverse Events [2 year]

   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. Device or Procedure-Related Adverse Events [3 year]

   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. Device or Procedure-Related Adverse Events [4 year]

   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. Device or Procedure-Related Adverse Events [5 year]

   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.

6. Major Adverse Event (MAE) [1 year]

   MAE includes death, myocardial infarction, stroke, reoperation for bleeding, renal failure, pulmonary embolism, gastrointestinal hemorrhage, rehospitalization.

7. Major Adverse Event (MAE) [2 year]

   MAE includes death, myocardial infarction, stroke, reoperation for bleeding, renal failure, pulmonary embolism, gastrointestinal hemorrhage, rehospitalization.

8. Major Adverse Event (MAE) [3 year]

   MAE includes death, myocardial infarction, stroke, reoperation for bleeding, renal failure, pulmonary embolism, gastrointestinal hemorrhage, rehospitalization.

9. Major Adverse Event (MAE) [4 year]

   MAE includes death, myocardial infarction, stroke, reoperation for bleeding, renal failure, pulmonary embolism, gastrointestinal hemorrhage, rehospitalization.

10. Major Adverse Event (MAE) [5 year]

    MAE includes death, myocardial infarction, stroke, reoperation for bleeding, renal failure, pulmonary embolism, gastrointestinal hemorrhage, rehospitalization.

11. Functional Change in New York Heart Association (NYHA) Classification [1 year]

    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.

12. Change in Quality of Life (QOL) is evaluated with Kansas City Cardiomyopathy (KCCQ) [1 year]

    KCCQ score ranges from 0 to 100, which 0 reflects the worst health status and 100 reflects the best health status.

13. Change in Quality of Life (QOL) is evaluated with Six Minute Walk Test (6MWT) [1 year]

    6MWT distance is recorded and compared with baseline during follow-up.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Beijing Anzhen Hospital	Beijing	Beijing	China	100029
2	Fu Wai Hospital	Beijing	Beijing	China	100037
3	Guangdong Provincial People's Hospital	Guangzhou	Guangdong	China	510000
4	Wuhan Union Hospital	Wuhan	Hubei	China	430000
5	Xijing Hospital	Xi'an	Shaanxi	China	710000
6	Changhai Hospital	Shanghai	Shanghai	China	200433
7	Shanghai Zhongshan Hospital	Shanghai	Shanghai	China
8	West China Hospital	Chengdu	Sichuan	China	610000
9	The Second Affiliated Hospital Zhejiang University School of Medicine	Hangzhou	Zhejiang	China	310000

Sponsors and Collaborators

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

Investigators

• Principal Investigator: Zhiyun Xu, MD, Changhai Hospital
• Study Director: Fanglin Lu, MD, Changhai Hospital
• Principal Investigator: Junbo Ge, MD, Shanghai Zhongshan Hospital
• Principal Investigator: Shengshou Hu, MD, Fuwai Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Zhiyun Xu, Chair of Department of Cardiovascular Surgery, Changhai Hospital
• ClinicalTrials.gov Identifier: NCT05194423
• Other Study ID Numbers: TRAVEL II
• First Posted: Jan 18, 2022
• Last Update Posted: Jan 18, 2022
• Last Verified: Dec 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Zhiyun Xu, Chair of Department of Cardiovascular Surgery, Changhai Hospital: Tricuspid valve regurgitation; Transcatheter tricuspid valve replacement; LuX-Valve
• Additional relevant MeSH terms: Tricuspid Valve Insufficiency

Study Results

No Results Posted as of Jan 18, 2022