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

August 26, 2026 updated by: Jenscare Innovation Inc.

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

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

680

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V6Z 1Y6
    • Ontario
      • Ottawa, Ontario, Canada, K1Y 4W7
      • Toronto, Ontario, Canada, M5B 1W8
    • Quebec
      • Montreal, Quebec, Canada, H1T 1C8
      • Québec, Quebec, Canada, G1V 4G5
        • Recruiting
        • Santé Québec - Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval
        • Contact:
  • United States
    • Florida
      • Naples, Florida, United States, 34102
        • Recruiting
        • NCH Rooney Heart Institute (NAPLES COMPREHENSIVE HEALTH)
        • Contact:
    • New York
      • The Bronx, New York, United States, 10467

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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 Transcatheter 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 30 days 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.
  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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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)
Time Frame: 30 Day Post-Procedure

Rate of Major Adverse Events (MAE) 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
Rate of Composite Clinical Success
Time Frame: 12 Months Post-Procedure
Percentage (%) of participants achieving composite clinical success at 12 months. Composite clinical success is defined as meeting all of the following criteria: Patient survival, Free from heart failure hospitalization, No tricuspid valve surgery or percutaneous intervention
12 Months Post-Procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jenscare Innovation Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 15, 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)

August 28, 2026

Last Update Submitted That Met QC Criteria

August 26, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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