Brief Summary

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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

150

participants targeted

Target at P75+ for not_applicable

Timeline

10mo left

Started Mar 2022

Longer than P75 for not_applicable

Geographic Reach

1 country

9 active sites

Status

recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

5 years study duration

Study Progress84%

Mar 2022Mar 2027

First Submitted

Initial submission to the registry

December 28, 2021

Completed

21 days until next milestone

First Posted

Study publicly available on registry

January 18, 2022

Completed

1 month until next milestone

Study Start

First participant enrolled

March 1, 2022

Completed

5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2027

Expected

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2027

Last Updated

January 18, 2022

Status Verified

December 1, 2021

Enrollment Period

5 years

First QC Date

December 28, 2021

Last Update Submit

December 28, 2021

Conditions

Tricuspid Valve Regurgitation

Keywords

Tricuspid valve regurgitationTranscatheter tricuspid valve replacementLuX-Valve

Outcome Measures

Primary Outcomes (2)

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

Secondary Outcomes (13)

Device or Procedure-Related Adverse Events
1 year
Device or Procedure-Related Adverse Events
2 year
Device or Procedure-Related Adverse Events
3 year
Device or Procedure-Related Adverse Events
4 year
Device or Procedure-Related Adverse Events
5 year
+8 more secondary outcomes

Study Arms (1)

Tricuspid Valve Replacement System via jugular vein

EXPERIMENTAL

Subjects who received transcatheter tricuspid valve replacement with LuX-Valve and delivery system via jugular vein will be included in this arm.

Device: Tricuspid Valve Replacement System via jugular vein

Interventions

Tricuspid Valve Replacement System via jugular veinDEVICE

To eliminate the tricuspid regurgitation through orthotopically replacing tricuspid valve with LuX-Valve system via jugular vein.

Tricuspid Valve Replacement System via jugular vein

Eligibility Criteria

Age50 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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).

You may not qualify if:

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Changhai Hospitallead
Shanghai Zhongshan Hospitalcollaborator
Fu Wai Hospital, Beijing, Chinacollaborator
Beijing Anzhen Hospitalcollaborator
Union Hospital, Tongji Medical College, Huazhong University of Science and Technologycollaborator
West China Hospitalcollaborator
Xijing Hospitalcollaborator
Guangdong Provincial People's Hospitalcollaborator
Second Affiliated Hospital, School of Medicine, Zhejiang Universitycollaborator

Study Sites (9)

Beijing Anzhen Hospital

Beijing, Beijing Municipality, 100029, China

NOT YET RECRUITING

Fu Wai Hospital

Beijing, Beijing Municipality, 100037, China

NOT YET RECRUITING

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, 510000, China

NOT YET RECRUITING

Wuhan Union Hospital

Wuhan, Hubei, 430000, China

NOT YET RECRUITING

Xijing Hospital

Xi'an, Shaanxi, 710000, China

NOT YET RECRUITING

Changhai Hospital

Shanghai, Shanghai Municipality, 200433, China

RECRUITING

Shanghai Zhongshan Hospital

Shanghai, Shanghai Municipality, China

RECRUITING

West China Hospital

Chengdu, Sichuan, 610000, China

NOT YET RECRUITING

The Second Affiliated Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310000, China

NOT YET RECRUITING

MeSH Terms

Conditions

Tricuspid Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve DiseasesHeart DiseasesCardiovascular Diseases

Study Officials

Zhiyun Xu, MD
Changhai Hospital
PRINCIPAL INVESTIGATOR
Fanglin Lu, MD
Changhai Hospital
STUDY DIRECTOR
Junbo Ge, MD
Shanghai Zhongshan Hospital
PRINCIPAL INVESTIGATOR
Shengshou Hu, MD
Chinese Academy of Medical Sciences, Fuwai Hospital
PRINCIPAL INVESTIGATOR

Central Study Contacts

Fan Qiao, MD

CONTACT

+8613564620805 qiaofan@smmu.edu.cn

Fan Yang, MD

CONTACT

+8618321785183 dearyangf@126.com

Study Design

Study Type: interventional
Phase: not applicable
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Chair of Department of Cardiovascular Surgery

Study Record Dates

First Submitted

December 28, 2021

First Posted

January 18, 2022

Study Start

March 1, 2022

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

March 1, 2027

Last Updated

January 18, 2022

Record last verified: 2021-12

Data Sharing

IPD Sharing: Will not share

Locations

CN(9)

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (13)

Study Arms (1)

Tricuspid Valve Replacement System via jugular vein

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (9)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

Data Sharing

Locations