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
260 weeks
Total Duration
On this page
Sponsors
C
Changhai Hospital
Lead Sponsor
S
Shanghai Zhongshan Hospital
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 via jugular vein which are intended to use in symptomatic patients with severe tricuspid regurgitation and high surgical risk.
CONDITIONS
Official 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 time of consent
- Provided written informed consent
- 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 the intervention
- New York Heart Association (NYHA) 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 procedure
- Tricuspid stenosis or other anatomy disorders unsuitable for the procedure
- Depressed right heart function (TAPSE less than 10 mm or right ventricle FAC less than 20%)
- Aortic stenosis, aortic regurgitation (3+ or more), mitral stenosis, or mitral regurgitation (3+ or more)
- Active endocarditis or other infectious diseases
- Untreated severe coronary artery disease
- Percutaneous coronary intervention, cerebrovascular accident, or surgical intervention within 3 months prior
- Coagulation disorders
- Known allergy, hypersensitivity, or contraindication to procedure materials or drugs
- 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: 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
CONTACT
F
Fan Yang, 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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