Transcatheter replacement of the tricuspid valve using LuX-Valve via the jugular vein

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The TRAVEL II trial evaluates the safety and effectiveness of the LuX-Valve transcatheter tricuspid valve replacement system delivered through the jugular vein. This prospective multi-center single-arm trial targets symptomatic patients with severe tricuspid regurgitation who are at high surgical risk. Participants will undergo a series of assessments to confirm their eligibility, and those who qualify will receive the LuX-Valve implantation after providing informed consent.

Why it matters

Who can join: the full rules

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.

Where it's running

• Changhai Hospital
  Shanghai, Shanghai Municipality, China Recruiting
• Shanghai Zhongshan Hospital
  Shanghai, Shanghai Municipality, China Recruiting
• Beijing Anzhen Hospital
  Beijing, Beijing Municipality, China Not yet recruiting
• Fu Wai Hospital
  Beijing, Beijing Municipality, China Not yet recruiting
• Guangdong Provincial People's Hospital
  Guangzhou, Guangdong, China Not yet recruiting
• Wuhan Union Hospital
  Wuhan, Hubei, China Not yet recruiting

Study contacts

• Principal investigator: Zhiyun Xu, MD — Changhai Hospital
• Study coordinator: Fan Qiao, MD
• Email: qiaofan@smmu.edu.cn
• Phone: +8613564620805

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• TruGamma tricuspid valve replacement for high-risk patients

  This trial tests the TruGamma tricuspid valve replacement system in high-risk patients with severe tricuspid regurgitation to see if it is safe and helps symptoms when added to standard medical care.

  Recruiting Jiangsu Trulive Medical Co., Ltd · Beijing, Beijing Municipality · NCT07691307

• Transcatheter Tricuspid Valve Replacement for Severe Tricuspid Regurgitation

  This trial tests the Laplace TTVR System to see if it safely and effectively treats adults with severe tricuspid regurgitation.

  Recruiting at 2 sites Laplace Interventional, Inc · Tulsa, Oklahoma and 1 other locations · NCT07687485

• Vyne TriNova Transcatheter Tricuspid Valve Replacement study for severe tricuspid regurgitation

  This trial tests the VDyne TriNova system in adults with symptomatic severe tricuspid regurgitation to see if it is safe and helps heart symptoms compared with an alternative device.

  Recruiting at 12 sites VDyne, Inc. · Phoenix, Arizona and 11 other locations · NCT07516444

• Lead-related tricuspid valve leakage after first-time pacemaker or ICD implantation

  This project will see if a new transvenous pacemaker or ICD lead causes new or worse tricuspid valve regurgitation in people getting their first device.

  Recruiting Clinic for General and Interventional Cardiology/Angiology, Herz- und Diabeteszentrum NRW · Bad Oeynhausen, North Rhine-Westphalia · NCT07342036

• Tracking progression and consequences of heart valve disease

  This project will follow adults with moderate or worse valve disease to see if clinical tests and imaging can predict when their condition will get worse.

  Recruiting at 15 sites Second Affiliated Hospital, Zhejiang University, School of Medicine · Fuzhou, Fujian and 14 other locations · NCT07267117

• Assessment of the inQB8 Tricuspid Valve Replacement System

  This study is testing a new valve replacement system to see if it can safely help people with severe tricuspid valve problems feel better.

  Recruiting at 8 sites inQB8 Medical Technologies, LLC · Los Angeles, California and 7 other locations · NCT06611579

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.