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Recruiting NCT05194423

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

No phase Interventional Tricuspid Valve Regurgitation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Tricuspid Valve Replacement System via jugular vein.
Who it may be relevant to
Registry conditions: Tricuspid Valve Regurgitation. Basic parameters: from 50 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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

Detailed description

The TRAVEL II study is a prospective multi-center single-arm trial for transcatheter tricuspid valve replacement with LuX-Valve via jugular vein. 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 via jugular vein if an informed consent is obtained.

Interventions

  • Device Tricuspid Valve Replacement System via jugular vein
    To eliminate the tricuspid regurgitation through orthotopically replacing tricuspid valve with LuX-Valve system via jugular vein.

Primary outcome measures

  • Death [Time frame: 1 year]
  • Tricuspid Regurgitation Reduction [Time frame: 1 year]
Secondary outcome measures (12)
  • Device or Procedure-Related Adverse Events [Time frame: 1 year]
  • Device or Procedure-Related Adverse Events [Time frame: 2 year]
  • Device or Procedure-Related Adverse Events [Time frame: 3 year]
  • Device or Procedure-Related Adverse Events [Time frame: 4 year]
  • Device or Procedure-Related Adverse Events [Time frame: 5 year]
  • Major Adverse Event (MAE) [Time frame: 1 year]
  • Major Adverse Event (MAE) [Time frame: 2 year]
  • Major Adverse Event (MAE) [Time frame: 3 year]
  • Major Adverse Event (MAE) [Time frame: 4 year]
  • Major Adverse Event (MAE) [Time frame: 5 year]
  • Functional Change in New York Heart Association (NYHA) Classification [Time frame: 1 year]
  • Change in Quality of Life (QOL) is evaluated with Kansas City Cardiomyopathy (KCCQ) [Time frame: 1 year]

Eligibility criteria

Inclusion criteria

  • Age ≥ 50 years at time of consent.
  • Subjects or subject's legal representative has been informed of the nature of the study and provided written informed consent.
  • 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.
  • Subjects must guarantee they won't participate in any other clinical trial for a period of one year after the intervention.
  • Subjects are with New York Heart Association (NYHA) Functional Class III or IV.
  • Subjects are with normal left heart function (EF ≥ 50%).
  • No indications for left-sided or pulmonary valve intervention.
  • 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

  • Subjects with pulmonary hypertension (systolic pressure ≥ 55mmHg determined by right heart catheterization).
  • Subjects with previous transcatheter or surgical tricuspid valve procedure.
  • Subjects with tricuspid stenosis or other anatomy disorders that unsuitable for the procedure.
  • Subjects with depressed right heart function (tricuspid annular plane systolic excursion (TAPSE) < 10mm or right ventricle fractional area change (FAC) < 20%).
  • 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+).
  • Subjects with active endocarditis or other infectious diseases.
  • Subjects with untreated severe coronary artery disease.
  • Subjects with percutaneous coronary intervention, cerebrovascular accident or surgical intervention within 3 months of the date of the procedure.
  • Subjects with coagulation disorders.
  • Subjects with known allergy, hypersensitivity or contraindication to the material or drugs used in the procedure.
  • Subjects with cognitive disorders that can not cooperate the study or follow-up.
  • Subjects with less than 12 months life expectancy because of non-cardiac conditions.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 9 centers
  • Beijing Anzhen Hospital — Beijing
  • Fu Wai Hospital — Beijing
  • Guangdong Provincial People's Hospital — Guangzhou
  • Wuhan Union Hospital — Wuhan
  • Xijing Hospital — Xi'an
  • Changhai Hospital — Shanghai
  • Shanghai Zhongshan Hospital — Shanghai
  • West China Hospital — Chengdu
  • … and 1 more center

Identifiers

NCT: NCT05194423 · TRAVEL II

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗