Transcatheter replacement of the tricuspid valve using LuX-Valve

THE TRAVEL TRIAL: Transcatheter Right Atrial-ventricular Valve rEplacement With LuX-Valve

This study is testing a new, less invasive heart valve replacement called the LuX-Valve for people with severe tricuspid regurgitation who can't have traditional surgery.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 150 (estimated)
• Ages: 50 Years and up
• Sex: All
• Sponsor: Changhai Hospital (other)
• Locations: 8 sites (Beijing, Beijing Municipality and 7 other locations)
• Trial ID: NCT04436653 on ClinicalTrials.gov

What this trial studies

The TRAVEL trial evaluates the safety and effectiveness of the LuX-Valve transcatheter system for patients with severe tricuspid regurgitation who are at high surgical risk. This prospective multi-center trial involves a series of physical, imaging, and laboratory exams to confirm eligibility based on specific criteria. Eligible participants will receive the LuX-Valve implantation after providing informed consent. The study aims to provide a less invasive treatment option for patients who are not suitable candidates for traditional surgery.

Who should consider this trial

Good fit: Ideal candidates are patients aged 50 and older with severe tricuspid regurgitation and high surgical risk.

Not a fit: Patients with indications for left-sided or pulmonary valve intervention may not benefit from this study.

Why it matters

Potential benefit: If successful, this could provide a less invasive treatment option for patients suffering from severe tricuspid regurgitation.

How similar studies have performed: Other studies have shown promise with transcatheter valve replacement approaches, indicating potential for success in this novel application.

Eligibility criteria

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 this trial is running

Beijing, Beijing Municipality and 7 other locations

• Beijing Anzhen Hospital — Beijing, Beijing Municipality, China (RECRUITING)
• Fu Wai Hospital — Beijing, Beijing Municipality, China (RECRUITING)
• Guangdong Provincial People's Hospital — Guangzhou, Guangdong, China (RECRUITING)
• Wuhan Union Hospital — Wuhan, Hubei, China (RECRUITING)
• Xijing Hospital — Xi'an, Shaanxi, China (RECRUITING)
• Changhai Hospital — Shanghai, Shanghai Municipality, China (RECRUITING)
• West China Hospital — Chengdu, Sichuan, China (RECRUITING)
• The Second Affiliated Hospital Zhejiang University School of Medicine — Hangzhou, Zhejiang, China (RECRUITING)

Study contacts

• Principal investigator: Zhiyun Xu, MD. — Changhai Hospital
• Study coordinator: Zhao An, MD.

Conditions: Tricuspid Valve Insufficiency, Tricuspid Regurgitation, LuX-Valve, Transcatheter Valve Replacement