Clinical trial NCT04436653: THE TRAVEL TRIAL: Transcatheter Right Atrial-ventricular Valve rEplacement With LuX-Valve
Official title: THE TRAVEL TRIAL: Transcatheter Right Atrial-ventricular Valve rEplacement With LuX-Valve
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Tricuspid Valve Insufficiency
Keywords: Tricuspid Regurgitation
LuX-Valve
Transcatheter Valve Replacement
Lead sponsor: Changhai Hospital
Sponsor class: OTHER
Collaborators: name: Fu Wai Hospital, Beijing, China
name: Beijing Anzhen Hospital
name: Wuhan Union Hospital, China
name: West China Hospital
name: Xijing Hospital
name: Guangdong Provincial People's Hospital
name: Second Affiliated Hospital, School of Medicine, Zhejiang University
First posted: 2020-06-18
Enrollment: 150
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is a prospective, multi-center single-arm trial in seven centers in China. A minimum of 150 subjects will be enrolled in this study and followed-up at discharge (≤ 10 days post operation), 30 days, 6 months, 1, 2, 3, 4, 5 years.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Death
timeFrame: 1 Year
measure: Tricuspid Regurgitation Reduction
timeFrame: 1 Year
Secondary outcomes:
measure: Device or Procedure-Related Adverse Events
timeFrame: 1 Year
measure: Device or Procedure-Related Adverse Events
timeFrame: 2 Year
measure: Device or Procedure-Related Adverse Events
timeFrame: 3 Year
measure: Device or Procedure-Related Adverse Events
timeFrame: 4 Year
measure: Device or Procedure-Related Adverse Events
timeFrame: 5 Year
measure: Major Adverse Event (MAE)
timeFrame: 1 Year
measure: Major Adverse Event (MAE)
timeFrame: 2 Year
measure: Major Adverse Event (MAE)
timeFrame: 3 Year
measure: Major Adverse Event (MAE)
timeFrame: 4 Year
measure: Major Adverse Event (MAE)
timeFrame: 5 Year
measure: Functional Change in New York Heart Association (NYHA) Classification
timeFrame: 1 Year
measure: Change in Quality of Life (QOL) is evaluated with Kansas City Cardiomyopathy (KCCQ)
timeFrame: 1 Year
measure: Change in Quality of Life (QOL) is evaluated with Six Minute Walk Test (6MWT)
timeFrame: 1 Year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Anzhen Hospital
state: Beijing
city: Beijing
country: China
facility: Fu Wai Hospital
state: Beijing
city: Guangzhou
country: China
facility: Guangdong Provincial People's Hospital
state: Guangdong
city: Wuhan
country: China
facility: Wuhan Union Hospital
state: Hubei
city: Xi'an
country: China
facility: Xijing Hospital
state: Shaanxi
city: Shanghai
country: China
facility: Changhai Hospital
state: Shanghai
city: Chengdu
country: China
facility: West China Hospital
state: Sichuan
city: Hangzhou
country: China
facility: The Second Affiliated Hospital Zhejiang University School of Medicine
state: Zhejiang
Study officials:
affiliation: Changhai Hospital
name: Zhiyun Xu, MD.
role: PRINCIPAL_INVESTIGATOR
affiliation: Fu Wai Hospital
name: Shengshou Hu, MD.
role: STUDY_CHAIR
affiliation: Changhai Hospital
name: Fanglin Lu, MD.
role: STUDY_DIRECTOR
References: