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

Not Applicable

Recruiting

• Conditions: Tricuspid Valve Insufficiency
• Interventions: Device: Tricuspid Valve Replacement System

• Registration Number: NCT04436653
• Lead Sponsor: Changhai Hospital

Brief Summary

The trial aims to evaluate the safety and effectiveness of LuX-Valve transcatheter tricuspid valve and delivery system which are intended to use in symptomatic patients with severe tricuspid regurgitation and high surgical risk.

Detailed Description

The TRAVEL study is a prospective multi-center single-arm trial for transcatheter tricuspid valve replacement with LuX-Valve. A series of physical, imaging and laboratory exams will be performed to determine whether a subject has severe tricuspid regurgitation with high surgical risk. Subjects who meet the criteria will then receive LuX-Valve implantation if an informed consent is obtained.

Study Timeline

• Study Start: 2020-06-16
• Study First Submitted: 2020-06-16
• Study First Submitted QC: 2020-06-17
• Study First Posted: 2020-06-18
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-16
• Last Update Posted: 2020-11-17
• Primary Completion: 2026-06
• Study Completion: 2026-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Tricuspid Valve Replacement System	Tricuspid Valve Replacement System	Subjects who received transcatheter tricuspid valve replacement with LuX-Valve and delivery system will be included in this arm.

Primary Outcome Measures

Name	Time	Method
Death	1 Year	All-cause Death
Tricuspid Regurgitation Reduction	1 Year	Tricuspid regurgitation measured with echocardiography in core lab reduces at least 2 grades.

Secondary Outcome Measures

Name	Time	Method
Change in Quality of Life (QOL) is evaluated with Six Minute Walk Test (6MWT)	1 Year	6MWT distance is recorded and compared with baseline during follow-up.
Major Adverse Event (MAE)	5 Year	MAE includes death, myocardial infarction, stroke, reoperation for bleeding, renal failure, pulmonary embolism, gastrointestinal hemorrhage, rehospitalization.
Device or Procedure-Related Adverse Events	5 Year	Device related mortality, device malposition, right ventricular outflow tract obstruction, conduction system disturbances, new onset shunt across ventricular septum, coronary artery injury, valve failure, convert to open surgery, reintervention, embolization.
Functional Change in New York Heart Association (NYHA) Classification	1 Year	Subjects' heart function is ranged from NYHA I to IV based on how much a patient is limited during physical activity. NYHA I means no limited on physical activity while NYHA IV means unable to take any physical activity.
Change in Quality of Life (QOL) is evaluated with Kansas City Cardiomyopathy (KCCQ)	1 Year	KCCQ score ranges from 0 to 100, which 0 reflects the worst health status and 100 reflects the best health status.

Trial Locations

Locations (8)

Fu Wai Hospital; 🇨🇳 Beijing, Beijing, China

Changhai Hospital; 🇨🇳 Shanghai, Shanghai, China

Beijing Anzhen Hospital; 🇨🇳 Beijing, Beijing, China

Guangdong Provincial People's Hospital; 🇨🇳 Guangzhou, Guangdong, China

Xijing Hospital; 🇨🇳 Xi'an, Shaanxi, China

Wuhan Union Hospital; 🇨🇳 Wuhan, Hubei, China

West China Hospital; 🇨🇳 Chengdu, Sichuan, China

The Second Affiliated Hospital Zhejiang University School of Medicine; 🇨🇳 Hangzhou, Zhejiang, China