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

Launched by CHANGHAI HOSPITAL · Dec 28, 2021

Keywords

ClinConnect Summary

The TRAVEL II Trial is studying a new treatment for patients with severe tricuspid valve regurgitation, a condition where the heart's tricuspid valve does not close properly, leading to blood flow problems. This trial is testing the LuX-Valve, which is a special device delivered through a vein in the neck (the jugular vein) to replace the faulty tricuspid valve. This trial is specifically for patients who are experiencing significant symptoms and are deemed at high risk for traditional heart surgery.

To be eligible for the trial, participants must be at least 50 years old, have severe tricuspid valve problems confirmed by an echocardiogram, and have a certain level of heart function. Additionally, they should not have other significant heart issues or recent heart procedures. Those who join the trial can expect to be closely monitored throughout the process, and they will not be able to participate in other clinical trials for at least a year after the procedure. This study aims to provide a safer alternative for patients who might not be able to undergo standard surgery.

Gender

ALL

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.