Pivotal Trial to Evaluate TraNsvenous TrIcuspid Valve ReplacemenT With LuX-Valve Plus System (The TRINITY Pivotal Trial)

Pivotal TRIal to Evaluate TraNsvenous TrIcuspid Valve ReplacemenT With Lux Valve Plus System in Patients With Severe or Greater Tricuspid Regurgitation - Clinical SafetY and Effectiveness

The goal of this clinical trial is to learn if LuX-Valve Plus system works to treat symptomatic subjects with at least severe tricuspid regurgitation (TR). It will also learn about the safety of LuX-Valve Plus system.

Researchers will compare LuX-Valve Plus system to a conventional device called EVOQUE to see if LuX-Valve Plus system works to treat subjects with at least severe tricuspid regurgitation.

Participants will:

Undergo one procedure using the LuX-Valve Plus system or EVOQUE after passing screening and enrolling in the trial; Complete follow-up visits and examinations as required by the trial protocol; Report any adverse events

Study Overview

• Status: Not yet recruiting
• Conditions: Tricuspid Regurgitation (TR)
• Intervention / Treatment: Device: TTVI with LuX-Valve Plus System; Device: TTVI with EVOQUE

• Study Type: Interventional
• Enrollment (Estimated): 680
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Chen Jiao, MD; Phone Number: +86 13816576611; Email: jiaochen@jenscare.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

For the randomized study:

1. Subject is at least 21 years of age at time of consent.
2. Subject (or legal guardian) understands trial requirements and treatment procedures and is able to provide written informed consent.
3. Severe or greater TR as assessed on transthoracic echocardiography by core lab.
4. New York Heart Association (NYHA) Class II-IV.
5. On optimal medical therapy (OMT) for TR at the time of baseline assessment per site Heart Team. OMT includes stable oral diuretic medications unless patient has a documented history of intolerance.
6. The site Heart Team concurs that the patient is a good candidate for transcatheter tricuspid valve replacement and suitable for LuX-Valve Plus system by core lab.
7. The commercial sponsor for EVOQUE deems that the patient is a good candidate for EVOQUE valve (control arm).

For single arm cohort ("Not Suitable for Conventional TTVI")

1. Meets all criteria 1-6 above
2. The EVOQUE commercial sponsor deems the anatomy unsuitable for EVOQUE tricuspid valve replacement, or the annular perimeter is smaller or greaterthan EVOQUE commercial Instructions for Use (IFU), as determined by the clinical site
3. Two independent Structural Cardiologists determine the patient "Not Suitable" for Triluminate edge to edge repair

Exclusion Criteria:

1. Left ventricular ejection fraction (LVEF) <35%.
2. Pulmonary arterial systolic pressure (PASP) >60 mmHg by echo Doppler (unless right heart catheterization [RHC] demonstrates PASP ≤60mmHg); in case RHC is performed, PASP >2/3 systemic BP with PVR >5 Wood units after vasodilator challenge, in the absence of symptomatic hypotension or systolic BP <90 mmHg.
3. Evidence of intracardiac mass, thrombus, or vegetation.
4. Ebstein Anomaly or congenital right ventricular dysplasia.
5. Surgical or interventional correction is indicated for other concomitant valvular diseases (subjects with concomitant valvular disease may treat their respective valve first and wait 2 months before being reassessed for the trial).
6. Subjects with valve prostheses implanted in the tricuspid valve.
7. Pre-existing prosthetic valve(s) (other than tricuspid ones) with clinically significant prosthetic dysfunction.
8. Active infection, infective endocarditis or sepsis within 3 months, or infections requiring antibiotics treatment within two weeks prior to planned procedure.
9. Untreated clinically significant coronary artery disease requiring revascularization.
10. Acute myocardial infarction or unstable ischemia-related angina within 30 days prior to the planned procedure.
11. Any percutaneous coronary, intracardiac or carotid intervention within 30 days prior to the planned procedure.
12. Cerebrovascular stroke (ischemic or bleeding) within 3 months prior to enrollment.
13. Active peptic ulcer or active gastrointestinal bleeding within 3 months prior to enrollment.
14. Blood dyscrasias as defined: leukopenia (WBC <1000 mm3), thrombocytopenia (platelet count <50,000 cells/mm3), history of bleeding diathesis, or coagulopathy.
15. Inability to tolerate anticoagulation or antiplatelet therapy.
16. Renal insufficiency (eGFR< 30ml/min [per the CKD-EPI formula] and/or renal replacement therapy).
17. Patients with hepatic insufficiency or cirrhosis with Child-Pugh score class C
18. Pregnancy or intent to become pregnant prior to completion of all protocol follow-up requirements.
19. Severe Chronic Obstructive Pulmonary Disease requiring steroids or requiring continuous home oxygen.
20. Untreatable hypersensitivity or contraindication to any of the following: all antiplatelets, all anticoagulants, nitinol alloys (nickel and titanium), bovine tissue, glutaraldehyde, or contrast media.
21. Estimated life expectancy <12 months.
22. Subjects currently participating in another clinical trial of an investigational drug or device that has not yet completed its primary endpoint.
23. Subjects with current history of illicit drug use.
24. Any other condition making it unlikely the patient will be able to complete all protocol procedure and follow-ups determined by the investigator.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Randomized cohort (EVOQUE Eligible Cohort): LuX-Valve	Device: TTVI with LuX-Valve Plus System; Transvenous tricuspid valve replacement with Lux-Valve Plus System in patients with severe or greater Tricuspid Regurgitation despite optimal medical therapy (OMT)
Active Comparator: Randomized cohort (EVOQUE Eligible Cohort): EVOQUE	Device: TTVI with EVOQUE; Transvenous tricuspid valve replacement with EVOQUE in patients with severe or greater Tricuspid Regurgitation despite optimal medical therapy (OMT)
Experimental: Single-arm cohort ("Not Suitable for Conventional TTVI"cohort): LuX-Valve	Device: TTVI with LuX-Valve Plus System; Transvenous tricuspid valve replacement with Lux-Valve Plus System in patients with severe or greater Tricuspid Regurgitation despite optimal medical therapy (OMT)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of Major Adverse Events (MAE)	Rate of Major Adverse Events (MAE) in experimental arm (LuX-Valve & EVOQUE) at 30 days consisting of the following components: Cardiovascular Mortality; Myocardial Infarction (MI), periprocedural and spontaneous; All Stroke, disabling and non-disabling; New need for renal replacement therapy; Severe bleeding (includes type 3b or higher as defined by Tricuspid Valve Academic Research Consortium [TVARC]; Non-elective tricuspid valve re-intervention, surgery or transcatheter; Major access site and vascular complications; Major cardiac structural complications; Device-related pulmonary embolism; Arrhythmia and conduction disorders requiring permanent pacing	30 Day Post-Procedure
Hierarchical composite endpoint: All-cause mortality, Heart failure hospitalization, and Tricuspid valve surgery or percutaneous intervention	Comparison of number of wins with composite endpoint events or improvement between experimental and active comparator arms	12 Months Post-Procedure

Collaborators and Investigators

• Sponsor: Jenscare Innovation Inc.

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2038

Study Registration Dates

• First Submitted: February 27, 2026
• First Submitted That Met QC Criteria: March 5, 2026
• First Posted (Actual): March 6, 2026

Study Record Updates

• Last Update Posted (Actual): March 6, 2026
• Last Update Submitted That Met QC Criteria: March 5, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Tricuspid Regurgitation; Transvenous Tricuspid Replacement; LuX-Valve Plus System
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Valve Diseases; Tricuspid Valve Insufficiency; Therapeutics; Drug Therapy; Drug Delivery Systems
• Other Study ID Numbers: JSIN-TVS02-PT-CIP-2601

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes