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Clinical Trials in China / NCT05194423
Recruiting Not applicable

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

NCT05194423 · tracked via the Priya Life Science China tracker
Sponsor
Changhai Hospital
Phase
Not applicable
Started
2022-03-01
Last updated
2022-01-18

Condition(s) studied

Tricuspid Valve Regurgitation

Investigational drug(s) / intervention(s)

Tricuspid Valve Replacement System via jugular vein

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

Study 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.

Eligibility

Sex
ALL
Min age
50 Years
Max age
Healthy volunteers
No
Inclusion Criteria: 1. Age ≥ 50 years at time of consent. 2. Subjects or subject's legal representative has been informed of the nature of the study and provided written informed consent. 3. 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. 4. Subjects must guarantee they won't participate in any other clinical trial for a period of one year after the intervention. 5. Subjects are with New York Heart Association (NYHA) Functional Class III or IV. 6. Subjects are with normal left heart function (EF ≥ 50%). 7. No indications for left-sided or pulmonary valve intervention. 8. 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: 1. Subjects with pulmonary hypertension (systolic pressure ≥ 55mmHg determined by right heart catheterization). 2. Subjects with previous transcatheter or surgical tricuspid valve procedure. 3. Subjects with tricuspid stenosis or other anatomy disorders that unsuitable for the procedure. 4. Subjects with depressed right heart function (tricuspid annular plane systolic excursion (TAPSE) \< 10mm or right ventricle fractional area change (FAC) \< 20%). 5. 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+). 6. Subjects with active endocarditis or other infectious diseases. 7. Subjects with untreated severe coronary artery disease. 8. Subjects with percutaneous coronary intervention, cerebrovascular accident or surgical intervention within 3 months of the date of the procedure. 9. Subjects with coagulation disorders. 10. Subjects with known allergy, hypersensitivity or contraindication to the material or drugs used in the procedure. 11. Subjects with cognitive disorders that can not cooperate the study or follow-up. 12. Subjects with less than 12 months life expectancy because of non-cardiac conditions.

Primary outcome measure(s)

Trial sites (9)

FacilityCityRegionStatus
Beijing Anzhen Hospital Beijing Beijing Municipality Not Yet Recruiting
Fu Wai Hospital Beijing Beijing Municipality Not Yet Recruiting
Guangdong Provincial People's Hospital Guangzhou Guangdong Not Yet Recruiting
Wuhan Union Hospital Wuhan Hubei Not Yet Recruiting
Xijing Hospital Xi'an Shaanxi Not Yet Recruiting
Changhai Hospital Shanghai Shanghai Municipality Recruiting
Shanghai Zhongshan Hospital Shanghai Shanghai Municipality Recruiting
West China Hospital Chengdu Sichuan Not Yet Recruiting
The Second Affiliated Hospital Zhejiang University School of Medicine Hangzhou Zhejiang Not Yet Recruiting

More Changhai Hospital trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05194423 on ClinicalTrials.gov ↗ ← All trials in China