Actively Recruiting
THE TRAVEL TRIAL: Transcatheter Right Atrial-ventricular Valve rEplacement With LuX-Valve
Led by Changhai Hospital · Updated on 2020-11-17
150
Participants Needed
8
Research Sites
310 weeks
Total Duration
On this page
Sponsors
C
Changhai Hospital
Lead Sponsor
F
Fu Wai Hospital, Beijing, China
Collaborating Sponsor
AI-Summary
What this Trial Is About
The trial aims to evaluate the safety and effectiveness of LuX-Valve transcatheter tricuspid valve and delivery system which are intended to use in symptomatic patients with severe tricuspid regurgitation and high surgical risk.
CONDITIONS
Official Title
THE TRAVEL TRIAL: Transcatheter Right Atrial-ventricular Valve rEplacement With LuX-Valve
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 50 years or older at time of consent
- Provided written informed consent or have a legal representative who did
- Confirmed high risk for tricuspid valve surgery with euroSCORE II of 7.0% or higher
- Will not participate in any other clinical trial for one year after intervention
- Classified as New York Heart Association Functional Class III or IV
- Normal left heart function with ejection fraction of 50% or higher
- No need for left-sided or pulmonary valve intervention
- Severe or greater tricuspid regurgitation confirmed by echocardiography (vena contracta width 7 mm or more, or effective regurgitant orifice area 40 mm2 or more)
You will not qualify if you...
- Pulmonary hypertension with systolic pressure 55 mmHg or higher
- Previous transcatheter or surgical tricuspid valve procedures
- Tricuspid stenosis or anatomy unsuitable for the procedure
- Depressed right heart function (TAPSE less than 10 mm or right ventricle fractional area change less than 20%)
- Aortic stenosis (mean gradient 40 mmHg or more or valve area 1 cm2 or less), aortic regurgitation grade 3+ or higher, mitral stenosis with valve area 1.5 cm2 or less, or mitral regurgitation grade 3+ or higher
- Active endocarditis or other infections
- Untreated severe coronary artery disease
- Percutaneous coronary intervention, stroke, or surgery within 3 months before procedure
- Coagulation disorders
- Known allergy, hypersensitivity, or contraindication to materials or drugs used
- Cognitive disorders preventing cooperation or follow-up
- Life expectancy less than 12 months due to non-cardiac conditions
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 8 locations
1
Beijing Anzhen Hospital
Beijing, Beijing Municipality, China, 100029
Actively Recruiting
2
Fu Wai Hospital
Beijing, Beijing Municipality, China, 100037
Actively Recruiting
3
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China, 510000
Actively Recruiting
4
Wuhan Union Hospital
Wuhan, Hubei, China, 430000
Actively Recruiting
5
Xijing Hospital
Xi'an, Shaanxi, China, 710000
Actively Recruiting
6
Changhai Hospital
Shanghai, Shanghai Municipality, China, 200433
Actively Recruiting
7
West China Hospital
Chengdu, Sichuan, China, 610000
Actively Recruiting
8
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310000
Actively Recruiting
Research Team
Z
Zhao An, MD.
CONTACT
F
Fan Qiao, MD.
CONTACT
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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