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

Primary Purpose

Tricuspid Valve Regurgitation

Status

Recruiting

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Tricuspid Valve Replacement System via jugular vein

About this trial

This is an interventional treatment trial for Tricuspid Valve Regurgitation focused on measuring Tricuspid valve regurgitation, Transcatheter tricuspid valve replacement, LuX-Valve

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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 are with New York Heart Association (NYHA) Functional Class III or IV.
Subjects are with normal left heart function (EF ≥ 50%).
No indications for left-sided or pulmonary valve intervention.
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:

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%).
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+).
Subjects with active endocarditis or other infectious diseases.
Subjects with untreated severe coronary artery disease.
Subjects with percutaneous coronary intervention, cerebrovascular accident or surgical intervention within 3 months of the date of the procedure.
Subjects with coagulation disorders.
Subjects with known allergy, hypersensitivity or contraindication to the material or drugs used in the procedure.
Subjects with cognitive disorders that can not cooperate the study or follow-up.
Subjects with less than 12 months life expectancy because of non-cardiac conditions.

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Tricuspid Valve Replacement System via jugular vein

Arm Description

Subjects who received transcatheter tricuspid valve replacement with LuX-Valve and delivery system via jugular vein will be included in this arm.

Outcomes

Primary Outcome Measures

Death

All-cause Death

Tricuspid Regurgitation Reduction

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

Secondary Outcome Measures

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

Major Adverse Event (MAE)

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

Major Adverse Event (MAE)

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

Major Adverse Event (MAE)

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

Major Adverse Event (MAE)

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

Major Adverse Event (MAE)

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

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.

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.

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.

Full Information

NCT ID

NCT05194423

First Posted

December 28, 2021

Last Updated

December 28, 2021

Sponsor

Changhai Hospital

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT05194423

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2021

Overall Recruitment Status

Recruiting

Study Start Date

March 1, 2022 (Anticipated)

Primary Completion Date

March 2027 (Anticipated)

Study Completion Date

March 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Changhai Hospital

Collaborators

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Tricuspid Valve Regurgitation

Keywords

Tricuspid valve regurgitation, Transcatheter tricuspid valve replacement, LuX-Valve

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

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.

Masking

None (Open Label)

Allocation

N/A

Enrollment

150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Tricuspid Valve Replacement System via jugular vein

Arm Type

Experimental

Arm Description

Subjects who received transcatheter tricuspid valve replacement with LuX-Valve and delivery system via jugular vein will be included in this arm.

Intervention Type

Device

Intervention Name(s)

Tricuspid Valve Replacement System via jugular vein

Intervention Description

To eliminate the tricuspid regurgitation through orthotopically replacing tricuspid valve with LuX-Valve system via jugular vein.

Primary Outcome Measure Information:

Title

Death

Description

All-cause Death

Time Frame

1 year

Title

Tricuspid Regurgitation Reduction

Description

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

Time Frame

1 year

Secondary Outcome Measure Information:

Title

Device or Procedure-Related Adverse Events

Description

Time Frame

1 year

Title

Device or Procedure-Related Adverse Events

Description

Time Frame

2 year

Title

Device or Procedure-Related Adverse Events

Description

Time Frame

3 year

Title

Device or Procedure-Related Adverse Events

Description

Time Frame

4 year

Title

Device or Procedure-Related Adverse Events

Description

Time Frame

5 year

Title

Major Adverse Event (MAE)

Description

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

Time Frame

1 year

Title

Major Adverse Event (MAE)

Description

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

Time Frame

2 year

Title

Major Adverse Event (MAE)

Description

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

Time Frame

3 year

Title

Major Adverse Event (MAE)

Description

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

Time Frame

4 year

Title

Major Adverse Event (MAE)

Description

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

Time Frame

5 year

Title

Functional Change in New York Heart Association (NYHA) Classification

Description

Time Frame

1 year

Title

Change in Quality of Life (QOL) is evaluated with Kansas City Cardiomyopathy (KCCQ)

Description

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

Title

Change in Quality of Life (QOL) is evaluated with Six Minute Walk Test (6MWT)

Description

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

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 are with New York Heart Association (NYHA) Functional Class III or IV. Subjects are with normal left heart function (EF ≥ 50%). No indications for left-sided or pulmonary valve intervention. 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: 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%). 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+). Subjects with active endocarditis or other infectious diseases. Subjects with untreated severe coronary artery disease. Subjects with percutaneous coronary intervention, cerebrovascular accident or surgical intervention within 3 months of the date of the procedure. Subjects with coagulation disorders. Subjects with known allergy, hypersensitivity or contraindication to the material or drugs used in the procedure. Subjects with cognitive disorders that can not cooperate the study or follow-up. Subjects with less than 12 months life expectancy because of non-cardiac conditions.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Fan Qiao, MD

Phone

+8613564620805

qiaofan@smmu.edu.cn

First Name & Middle Initial & Last Name or Official Title & Degree

Fan Yang, MD

Phone

+8618321785183

dearyangf@126.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Zhiyun Xu, MD

Organizational Affiliation

Changhai Hospital

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Fanglin Lu, MD

Organizational Affiliation

Changhai Hospital

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Junbo Ge, MD

Organizational Affiliation

Shanghai Zhongshan Hospital

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Shengshou Hu, MD

Organizational Affiliation

Fuwai Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Beijing Anzhen Hospital

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100029

Country

China

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Xu Meng, MD.

Phone

010-64456260

mxu@263.net

Facility Name

Fu Wai Hospital

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100037

Country

China

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Xiangbin Pan, MD.

Phone

010-68314466

xiangbin428@hotmail.com

Facility Name

Guangdong Provincial People's Hospital

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510000

Country

China

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Huiming Guo, MD.

guohuiming@vip.tom.com

Facility Name

Wuhan Union Hospital

City

Wuhan

State/Province

Hubei

ZIP/Postal Code

430000

Country

China

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Nianguo Dong, MD.

ng_dong@163.com

Facility Name

Xijing Hospital

City

Xi'an

State/Province

Shaanxi

ZIP/Postal Code

710000

Country

China

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jian Yang, MD.

yangjian1212@hotmail.com

First Name & Middle Initial & Last Name & Degree

Shiqiang Yu, MD.

yushiq@fmmu.edu.cn

Facility Name

Changhai Hospital

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200433

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Zhiyun Xu, MD.

Phone

021-31166666

zhiyunx@smmu.edu.cn

Facility Name

Shanghai Zhongshan Hospital

City

Shanghai

State/Province

Shanghai

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Junbo Ge, MD

Facility Name

West China Hospital

City

Chengdu

State/Province

Sichuan

ZIP/Postal Code

610000

Country

China

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Yingqiang Guo, MD.

Phone

+86 028 85421833

First Name & Middle Initial & Last Name & Degree

Mao Chen, MD.

hmaochen@vip.sina.com

Facility Name

The Second Affiliated Hospital Zhejiang University School of Medicine

City

Hangzhou

State/Province

Zhejiang

ZIP/Postal Code

310000

Country

China

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jianan Wang, MD.

wangjianan111@zju.edu.cn

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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