Actively Recruiting
THE TRAVEL II TRIAL: Transcatheter Right Atrial-ventricular Valve Replacement with LuX-Valve Via Jugular Vein
Led by Changhai Hospital · Updated on 2022-01-18
150
Participants Needed
9
Research Sites
N/A
Total Duration
On this page
Sponsors
C
Changhai Hospital
Lead Sponsor
S
Shanghai Zhongshan Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of the LuX-Valve transcatheter tricuspid valve and delivery system via the jugular vein in patients with severe tricuspid regurgitation who are at high risk for surgery. This prospective, multi-center, single-arm trial aims to determine if this device can help symptomatic patients who have limited options due to their surgical risk and valve condition. Participants in the study will undergo implantation of the LuX-Valve system through the jugular vein after being confirmed to have severe tricuspid regurgitation and high surgical risk. The trial involves only one treatment group where all subjects receive this transcatheter valve replacement. The device is designed to replace the tricuspid valve to reduce regurgitation and improve heart function. During the study, participants will have physical exams, imaging tests, and laboratory assessments to confirm eligibility and monitor outcomes. Researchers will track safety and effectiveness through measures including survival and reduction in tricuspid regurgitation at one year. Secondary outcomes include adverse events over up to five years, changes in heart function classification, quality of life assessments, and walking tests. The total duration includes at least one year of follow-up to evaluate these outcomes.
CONDITIONS
Brief Title
THE TRAVEL II TRIAL: Transcatheter Right Atrial-ventricular Valve rEplacement With LuX-Valve Via Jugular Vein
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 50 years or older at the time of consent
- Subject or their legal representative has given written informed consent
- Confirmed high surgical risk for tricuspid valve surgery (euroSCORE II 60; 7.0%) with expected benefit from the intervention
- Will not participate in any other clinical trial for one year after intervention
- New York Heart Association (NYHA) Functional Class III or IV
- Normal left heart function with ejection fraction (EF) 60; 50%
- No indications for left-sided or pulmonary valve intervention
- Severe or greater tricuspid regurgitation confirmed by echocardiography (vena contracta width 60; 7 mm or effective regurgitant orifice area 60; 40 mm2)
You will not qualify if you...
- Pulmonary hypertension with systolic pressure 60; 55 mmHg by right heart catheterization
- Previous transcatheter or surgical tricuspid valve procedure
- Tricuspid stenosis or other anatomical disorders unsuitable for the procedure
- Depressed right heart function (TAPSE < 10 mm or right ventricle fractional area change < 20%)
- Significant aortic or mitral valve disease (aortic stenosis mean gradient 60; 40 mmHg, aortic valve area 64; 1 cm2, aortic regurgitation 60; 3+, mitral stenosis 64; 1.5 cm2, or mitral regurgitation 60; 3+)
- Active endocarditis or other infectious diseases
- Untreated severe coronary artery disease
- Percutaneous coronary intervention, cerebrovascular accident, or surgical intervention within 3 months before procedure
- Coagulation disorders
- Known allergy or contraindication to materials or drugs used in the procedure
- Cognitive disorders preventing cooperation or follow-up
- Less than 12 months life expectancy due to non-cardiac conditions
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single procedure
Participants receive a transcatheter tricuspid valve replacement with the LuX-Valve system via the jugular vein.
1 procedure visit (in-person)
Duration - Up to 1 year
Participants are followed to monitor device performance, safety, and functional outcomes after the valve replacement.
Multiple visits over 1 year
Trial Site Locations
Total: 9 locations
1
Beijing Anzhen Hospital
Beijing, Beijing Municipality, China, 100029
Not Yet Recruiting
2
Fu Wai Hospital
Beijing, Beijing Municipality, China, 100037
Not Yet Recruiting
3
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China, 510000
Not Yet Recruiting
4
Wuhan Union Hospital
Wuhan, Hubei, China, 430000
Not Yet Recruiting
5
Xijing Hospital
Xi'an, Shaanxi, China, 710000
Not Yet Recruiting
6
Changhai Hospital
Shanghai, Shanghai Municipality, China, 200433
Actively Recruiting
7
Shanghai Zhongshan Hospital
Shanghai, Shanghai Municipality, China
Actively Recruiting
8
West China Hospital
Chengdu, Sichuan, China, 610000
Not Yet Recruiting
9
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310000
Not Yet Recruiting
Research Team
F
Fan Qiao, MD
F
Fan Yang, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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