NCT07454980 · Jenscare Innovation Inc.
Pivotal Trial to Evaluate TraNsvenous TrIcuspid Valve ReplacemenT With LuX-Valve Plus System (The TRINITY Pivotal Trial)
What this study is about
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.
View original scientific description
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.
Interventions
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)
DEVICE
TTVI with EVOQUE
Transvenous tricuspid valve replacement with EVOQUE in patients with severe or greater Tricuspid Regurgitation despite optimal medical therapy (OMT)
Primary outcome measures
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
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
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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.
- 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 Triluminate edge to edge repair
Exclusion criteria
- 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 2 months before being reassessed for the trial).
- Subjects with valve prostheses implanted in the tricuspid valve.
- 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 prior to completion of all protocol follow-up requirements.
- 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.
Where
- Naples, Florida
- The Bronx, New York
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 28, 2026 · Source of record for eligibility and locations