Tricuspid Regurgitation (TR)NCT07454980
Pivotal Trial to Evaluate TraNsvenous TrIcuspid Valve ReplacemenT With LuX-Valve Plus System (The TRINITY Pivotal Trial)
A study testing TTVI with LuX-Valve Plus System and TTVI with EVOQUE in people with Tricuspid Regurgitation (TR), run by Jenscare Innovation Inc. at 7 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Tricuspid Regurgitation (TR)
- What is being tested?
- TTVI with LuX-Valve Plus System and TTVI with EVOQUE
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 680 participants
- Where
- 7 sitesin 2 countries
- Study dates
- 15 Jul 2026to Dec 2038
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- For the randomized study:
- Subject is at least 21 years of age at time of consent.
- Subject (or legal guardian) understands trial requirements and treatment procedures and is able to provide written informed consent.
- Severe or greater TR as assessed on transthoracic echocardiography by core lab.
- New York Heart Association (NYHA) Class II-IV.
- 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.
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- 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.
- 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")
- Meets all criteria 1-6 above
- 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
- Two independent Structural Cardiologists determine the patient "Not Suitable" for Transcatheter edge to edge repair
Who cannot join
- Left ventricular ejection fraction (LVEF) <35%.
- 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.
- Evidence of intracardiac mass, thrombus, or vegetation.
- Ebstein Anomaly or congenital right ventricular dysplasia.
- 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).
- Subjects with valve prostheses implanted in the tricuspid valve.
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- Pre-existing prosthetic valve(s) (other than tricuspid ones) with clinically significant prosthetic dysfunction.
- Active infection, infective endocarditis or sepsis within 3 months, or infections requiring antibiotics treatment within two weeks prior to planned procedure.
- Untreated clinically significant coronary artery disease requiring revascularization.
- Acute myocardial infarction or unstable ischemia-related angina within 30 days prior to the planned procedure.
- Any percutaneous coronary, intracardiac or carotid intervention within 30 days prior to the planned procedure.
- Cerebrovascular stroke (ischemic or bleeding) within 3 months prior to enrollment.
- Active peptic ulcer or active gastrointestinal bleeding within 3 months prior to enrollment.
- Blood dyscrasias as defined: leukopenia (WBC <1000 mm3), thrombocytopenia (platelet count <50,000 cells/mm3), history of bleeding diathesis, or coagulopathy.
- Inability to tolerate anticoagulation or antiplatelet therapy.
- Renal insufficiency (eGFR< 30ml/min [per the CKD-EPI formula] and/or renal replacement therapy).
- Patients with hepatic insufficiency or cirrhosis with Child-Pugh score class C
- Pregnancy or intent to become pregnant.
- Severe Chronic Obstructive Pulmonary Disease requiring steroids or requiring continuous home oxygen.
- Untreatable hypersensitivity or contraindication to any of the following: all antiplatelets, all anticoagulants, nitinol alloys (nickel and titanium), bovine tissue, glutaraldehyde, or contrast media.
- Estimated life expectancy <12 months.
- Subjects currently participating in another clinical trial of an investigational drug or device that has not yet completed its primary endpoint.
- Subjects with current history of illicit drug use.
- Any other condition making it unlikely the patient will be able to complete all protocol procedure and follow-ups determined by the investigator.
Trial locations and contacts
7 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
7 sites in 2 countries
Canada5 sites, 5 recruiting
- Recruiting
Montreal Heart Institute
Montreal, Quebec, H1T 1C8
Walid Ben Ali, MD, walid.ben-ali.med@msss.gouv.qc.ca
- Recruiting
Ottawa Heart Institute Research Corporation
Ottawa, Ontario, K1Y 4W7
Omar Abdel Razek, MD, oabdel-razek@ottawaheart.ca
- Recruiting
Santé Québec - Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval
Québec, Quebec, G1V 4G5
Josep Rodés-Cabau, MD, josep.rodes@criucpq.ulaval.ca
- Recruiting
St. Michael's Hospital
Toronto, Ontario, M5B 1W8
Neil Fam, MD, Neil.Fam@unityhealth.to
- Recruiting
St. Paul's Hospital
Vancouver, British Columbia, V6Z 1Y6
Anson Cheung, MD, anson.cheung@phc.ca
United States2 sites, 2 recruiting
- Recruiting
NCH Rooney Heart Institute (NAPLES COMPREHENSIVE HEALTH)
Naples, Florida, 34102
Robert Cubeddu, MD, Robert.Cubeddu@NCHMD.org
- Recruiting
Montefiore Medical Center
The Bronx, New York, 10467
Edwin Ho, MD, eho1@montefiore.org
About this study
Official title: 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
- Conditions
- Tricuspid Regurgitation (TR)
- Being tested
- TTVI with LuX-Valve Plus System, TTVI with EVOQUE
- Keywords
- Tricuspid Regurgitation, Transvenous Tricuspid Replacement, LuX-Valve Plus System
- Medical subject headings
- Tricuspid Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TTVI with LuX-Valve Plus SystemDevice
Transvenous tricuspid valve replacement with Lux-Valve Plus System in patients with severe or greater Tricuspid Regurgitation despite optimal medical therapy (OMT)
TTVI with EVOQUEDevice
Transvenous tricuspid valve replacement with EVOQUE in patients with severe or greater Tricuspid Regurgitation despite optimal medical therapy (OMT)
| Study group | Role | What they receive |
|---|---|---|
| Randomized cohort (EVOQUE Eligible Cohort): LuX-Valve | Experimental | Not described Receives: Device: TTVI with LuX-Valve Plus System |
| Randomized cohort (EVOQUE Eligible Cohort): EVOQUE | Active comparator | Not described Receives: Device: TTVI with EVOQUE |
| Single-arm cohort ("Not Suitable for Conventional TTVI"cohort): LuX-Valve | Experimental | Not described Receives: Device: TTVI with LuX-Valve Plus System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Major Adverse Events (MAE)
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
Measured: 30 Day Post-Procedure
Rate of Composite Clinical Success
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
Measured: 12 Months Post-Procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2026
- Study start15 Jul 2026
- Primary completionDec 2029 (estimated)
- Study completionDec 2038 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tricuspid Regurgitation (TR)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study will consist of two cohorts. 1. EVOQUE Eligible Cohort: 400 subjects randomized 2:1 (LuX-Valve:EVOQUE) will be used to demonstrate that the LuX-Valve is noninferior to EVOQUE. These subjects will have met ALL the following requirements: * Met the inclusions/exclusion criteria, * Deemed a transcatheter candidate by the heart team, * Eligible for an EVOQUE device based on commercial sponsor assessment. 2. "Not Suitable for Conventional TTVI"cohort": A single arm study of 180 subjects will be used to demonstrate Lux meets a pre-specified performance goal. These subjects will have met ALL the following requirements: * Meets all inclusions/exclusion criteria. * Deemed suitable for transcatheter candidates by the heart team. * Deemed suitable for the LuX-Valve. * Deemed not suitable for an EVOQUE device based on commercial sponsor assessment. * Deemed not suitable for T-TEER based on echocardiographic assessment of two independent structural cardiologists
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 680 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jenscare Innovation Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07454980
- Sponsor's protocol ID
- JSIN-TVS02-PT-CIP-2601
- Status last verified
- Aug 2026
- First submitted
- 27 Feb 2026
- Last updated
- 28 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes