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

Launched by CHANGHAI HOSPITAL · Jun 17, 2020

Keywords

ClinConnect Summary

The TRAVEL TRIAL is studying a new treatment option for patients suffering from tricuspid valve insufficiency, a condition where the heart's tricuspid valve does not close properly, leading to blood flow problems. This trial is testing a device called the LuX-Valve, which is a special type of valve that can be placed in the heart without needing major surgery. It aims to help patients who have severe symptoms and are at high risk for traditional surgery.

To participate in the trial, patients should be at least 50 years old and have been diagnosed with severe tricuspid regurgitation, meaning their heart is not functioning well due to the faulty valve. Eligible participants should have normal heart function on the left side and should not have other significant heart issues. Participants can expect to receive close monitoring and support throughout the trial, and they will need to commit to not joining other clinical trials for one year after the procedure. This study is currently recruiting patients, and if you or a loved one think you might qualify, it’s a great opportunity to explore a potential new treatment.

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.