Tricuspid Valve RegurgitationNCT05194423
THE TRAVEL II TRIAL: Transcatheter Right Atrial-ventricular Valve rEplacement With LuX-Valve Via Jugular Vein
A study testing Tricuspid Valve Replacement System via jugular vein in people with Tricuspid Valve Regurgitation, run by Changhai Hospital at 9 sites in China.
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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Tricuspid Valve Regurgitation
- What is being tested?
- Tricuspid Valve Replacement System via jugular vein
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 9 sitesChina
- Study dates
- 1 Mar 2022to Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Show all 12Show fewer
- 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.
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
9 sites in 1 country
China9 sites, 9 recruiting
- Not yet recruiting
Beijing Anzhen Hospital
Beijing, Beijing Municipality, 100029
Xu Meng, MD., 010-64456260, mxu@263.net
- Not yet recruiting
Fu Wai Hospital
Beijing, Beijing Municipality, 100037
Xiangbin Pan, MD., 010-68314466, xiangbin428@hotmail.com
- Not yet recruiting
West China Hospital
Chengdu, Sichuan, 610000
Yingqiang Guo, MD., +86 028 85421833
Mao Chen, MD., hmaochen@vip.sina.com
- Not yet recruiting
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, 510000
Huiming Guo, MD., guohuiming@vip.tom.com
- Not yet recruiting
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310000
Jianan Wang, MD., wangjianan111@zju.edu.cn
- Recruiting
Changhai Hospital
Shanghai, Shanghai Municipality, 200433
Zhiyun Xu, MD., 021-31166666, zhiyunx@smmu.edu.cn
- Recruiting
Shanghai Zhongshan Hospital
Shanghai, Shanghai Municipality
Junbo Ge, MD
- Not yet recruiting
Wuhan Union Hospital
Wuhan, Hubei, 430000
Nianguo Dong, MD., ng_dong@163.com
- Not yet recruiting
Xijing Hospital
Xi'an, Shaanxi, 710000
Jian Yang, MD., yangjian1212@hotmail.com
Shiqiang Yu, MD., yushiq@fmmu.edu.cn
About this study
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.
Read the 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.
- Conditions
- Tricuspid Valve Regurgitation
- Being tested
- Tricuspid Valve Replacement System via jugular vein
- Keywords
- Tricuspid valve regurgitation, Transcatheter tricuspid valve replacement, LuX-Valve
- Medical subject headings
- Tricuspid Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tricuspid Valve Replacement System via jugular veinDevice
To eliminate the tricuspid regurgitation through orthotopically replacing tricuspid valve with LuX-Valve system via jugular vein.
| Study group | Role | What they receive |
|---|---|---|
| Tricuspid Valve Replacement System via jugular vein | Experimental | Subjects who received transcatheter tricuspid valve replacement with LuX-Valve and delivery system via jugular vein will be included in this arm. Receives: Device: Tricuspid Valve Replacement System via jugular vein |
What is being measured
The primary outcome is the main question the study is designed to answer.
Death
All-cause Death
Measured: 1 year
Tricuspid Regurgitation Reduction
Tricuspid regurgitation measured with echocardiography in core lab reduces at least 2 grades.
Measured: 1 year
Secondary outcomes (13)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 5 year
Major Adverse Event (MAE)
MAE includes death, myocardial infarction, stroke, reoperation for bleeding, renal failure, pulmonary embolism, gastrointestinal hemorrhage, rehospitalization.
Measured: 1 year
Major Adverse Event (MAE)
MAE includes death, myocardial infarction, stroke, reoperation for bleeding, renal failure, pulmonary embolism, gastrointestinal hemorrhage, rehospitalization.
Measured: 2 year
Major Adverse Event (MAE)
MAE includes death, myocardial infarction, stroke, reoperation for bleeding, renal failure, pulmonary embolism, gastrointestinal hemorrhage, rehospitalization.
Measured: 3 year
Major Adverse Event (MAE)
MAE includes death, myocardial infarction, stroke, reoperation for bleeding, renal failure, pulmonary embolism, gastrointestinal hemorrhage, rehospitalization.
Measured: 4 year
Major Adverse Event (MAE)
MAE includes death, myocardial infarction, stroke, reoperation for bleeding, renal failure, pulmonary embolism, gastrointestinal hemorrhage, rehospitalization.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2022
- Study start1 Mar 2022 (estimated)
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tricuspid Valve RegurgitationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Zhongshan Hospital, Fu Wai Hospital, Beijing, China, Beijing Anzhen Hospital, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, West China Hospital, Xijing Hospital, Guangdong Provincial People's Hospital, Second Affiliated Hospital, Zhejiang University, School of Medicine
- Responsible party
- Principal investigator, Zhiyun Xu, Changhai Hospital
- Investigators
- Zhiyun Xu, MD, Principal investigator, Changhai HospitalFanglin Lu, MD, Study director, Changhai HospitalJunbo Ge, MD, Principal investigator, Shanghai Zhongshan HospitalShengshou Hu, MD, Principal investigator, Chinese Academy of Medical Sciences, Fuwai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05194423
- Sponsor's protocol ID
- TRAVEL II
- Status last verified
- Dec 2021
- First submitted
- 28 Dec 2021
- Last updated
- 18 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- THE TRAVEL II TRIAL: Transcatheter Right Atrial-ventricular Valve rEplacement With LuX-Valve Via Jugular Vein
- ClinicalTrials.gov ID
- NCT05194423
- Acronym / sponsor ID
- TRAVEL II
- Conditions
- Tricuspid Valve Regurgitation
- Keywords
- Tricuspid valve regurgitation, Transcatheter tricuspid valve replacement, LuX-Valve
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Collaborators
- Shanghai Zhongshan Hospital, Fu Wai Hospital, Beijing, China, Beijing Anzhen Hospital, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, West China Hospital, Xijing Hospital, Guangdong Provincial People's Hospital, Second Affiliated Hospital, Zhejiang University, School of Medicine
- Study start
- 1 Mar 2022 (estimated)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 18 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Tricuspid Valve Replacement System via jugular vein | Experimental | Device: Tricuspid Valve Replacement System via jugular veinSubjects who received transcatheter tricuspid valve replacement with LuX-Valve and delivery system via jugular vein will be included in this arm. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (12 listed)
- 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+).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tricuspid Valve Replacement System via jugular veinTo eliminate the tricuspid regurgitation through orthotopically replacing tricuspid valve with LuX-Valve system via jugular vein. | Device | Tricuspid Valve Replacement System via jugular vein |
Primary outcome
Death
Time frame: 1 year
All-cause Death
Tricuspid Regurgitation Reduction
Time frame: 1 year
Tricuspid regurgitation measured with echocardiography in core lab reduces at least 2 grades.
13 secondary outcomes
Device or Procedure-Related Adverse Events
Time frame: 1 year
Device or Procedure-Related Adverse Events
Time frame: 2 year
Device or Procedure-Related Adverse Events
Time frame: 3 year
Device or Procedure-Related Adverse Events
Time frame: 4 year
Device or Procedure-Related Adverse Events
Time frame: 5 year
Major Adverse Event (MAE)
Time frame: 1 year
Major Adverse Event (MAE)
Time frame: 2 year
Major Adverse Event (MAE)
Time frame: 3 year
Major Adverse Event (MAE)
Time frame: 4 year
Major Adverse Event (MAE)
Time frame: 5 year
Functional Change in New York Heart Association (NYHA) Classification
Time frame: 1 year
Change in Quality of Life (QOL) is evaluated with Kansas City Cardiomyopathy (KCCQ)
Time frame: 1 year
Change in Quality of Life (QOL) is evaluated with Six Minute Walk Test (6MWT)
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Zhiyun Xu, MD principal investigator
Changhai Hospital
Fanglin Lu, MD study director
Changhai Hospital
Junbo Ge, MD principal investigator
Shanghai Zhongshan Hospital
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tricuspid Valve Replacement System via jugular vein in people with Tricuspid Valve Regurgitation, run by Changhai Hospital at 9 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fan Qiao, MD (+8613564620805, qiaofan@smmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Death (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2022.