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Tricuspid Regurgitation (TR)NCT06568003

TraNsvenous TrIcuspid Valve ReplacemenT With LuX-Valve Plus System (TRINITY-US)

A study testing Transcatheter Tricuspid Valve Intervention in people with Tricuspid Regurgitation (TR), run by Jenscare Innovation Inc. at 3 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The LuX-Valve Plus System is intended for the treatment of patients with at least severe TR who are symptomatic and determined by a Heart Team not to be suitable for surgical treatment. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Tricuspid Regurgitation (TR)
What is being tested?
Transcatheter Tricuspid Valve Intervention
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
3 sitesUnited States
Study dates
26 Sep 2024to Oct 2030
Phase
Interventional
Are there results?
Not yet: the study is under way

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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥18 years at time of consent
  • Severe or greater TR assessed on transthoracic echocardiography by Echocardiography Core Lab using a 5-grade classification (Mild, Moderate, Severe, Massive, Torrential).
  • New York Heart Association (NYHA) Class II-IV
  • The Patient is being treated on optimal dosage for diuretics at investigator discretion
  • The Site Heart Team concur the patient is not an optimal candidate for surgical treatment and it is anatomically suitable for transcatheter tricuspid valve replacement
  • Patient must be able to fully understand all aspects of the investigation that are relevant to the decision to participate and provide a written informed consent
  • Anatomical inclusion criteria confirmed by echocardiographic core lab, CT core lab and Eligibility Committee

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); or Right heart catheterization OR 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 correction is indicated for other concomitant valvular disease (subjects with concomitant valvular disease may treat their respective valve first and wait 2 months before being reassessed for the trial)
  • Patients with valve prostheses implanted in the tricuspid valve
Show all 27Show fewer
  • 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
  • Any coronary or intracardiac or carotid intervention within 30 days prior to the planned procedure
  • Cardiogenic shock manifested by low cardiac output, vasopressor dependence, or mechanical hemodynamic support TRINITY-US Trial #: Ver 1.0, 14 Nov 2023, Confidential Page 7 of 8
  • Cerebrovascular stroke (ischemic or bleeding) within prior 3 months to enrollment
  • Active peptic ulcer or active gastrointestinal bleeding within prior 3 months 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
  • Severe liver failure
  • Renal insufficiency (eGFR <30 mL/min [per the Cockcroft-Gault formula] and/or renal replacement therapy)
  • Uncontrolled atrial fibrillation (e.g., resting heart rate >120 bpm)
  • 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
  • Patients 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

3 sites in 1 country.

United States3 sites

  • Henry Ford Health System

    Detroit, Michigan, 48202

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048

  • Montefiore Medical Center

    New York, New York, 10467

Other trials in United States

About this study

Official title: TRIal to Evaluate TraNsvenous TrIcuspid Valve ReplacemenT With LuX-Valve Plus System in Patients With Severe or Greater Tricuspid Regurgitation - SafetY and Clinical Performance

The LuX-Valve Plus System is intended for the treatment of patients with at least severe TR who are symptomatic and determined by a Heart Team not to be suitable for surgical treatment. This study aims to assess the safety and effectiveness of the LuX-Valve Plus System in high-surgical risk patients with at least severe tricuspid regurgitation (TR).

Read the detailed description

Investigational Device:

The LuX-Valve Plus System consists of the following elements:

  1. a bioprosthetic valve consistent of bovine pericardial tissue mounted on a self-expanding nitinol stent frame (hereafter referred to as LuX-Valve Implant).The LuX-Valve Implant consists of a trileaflet bovine-pericardial-tissue valve, a nitinol self-expanding stent, a fabric skirt, a pair of clips, an anchoring pin and sutures.
  2. a catheter-based delivery system (hereafter referred to as LuX-Valve Delivery Device),
  3. an Introducer Kit for transvenous access, and
  4. a delivery system Stabilizer.
  • The LuX-Valve Implant sizes:
  • JS/TTVI-28-40, JS/TTVI-28-45, JS/TTVI-28-50, JS/TTVI- 28-55, JS/TTVI-30-40, JS/TTVI-30-45, JS/TTVI-30-50, JS/TTVI-30-55, JS/ TTVI-30-60, JS/TTVI-30-65
  • LuX--Valve Plus Delivery System
  • JS/TTVDJ-33
  • Introducer Kit
  • JS/SID01-33-100
  • Stabilizer o JS/STA-TJ01-01

Primary Objective:

To assess the safety and effectiveness of the LuX-Valve Plus System in patients with at least severe tricuspid regurgitation (TR) who are at high risk for surgical treatment.

Study Sites and Geography:

Up to 3 centers in the United States.

Number of Subjects:

Up to 15 subjects will be enrolled.

Indications for Use:

The LuX-Valve Plus System is intended for the improvement of health status in patients with at least severe TR who are symptomatic and determined by a Heart Team to be at high risk for surgical treatment.

Being tested
Transcatheter Tricuspid Valve Intervention
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.

  • Transcatheter Tricuspid Valve InterventionDevice

    Due to unsustainable effect of medical therapy and high risks of surgical treatment, transcatheter tricuspid valve intervention (TTVI) has been a major field of study in the world in the last 10 years. TTVI could potentially reduce TR with lower periprocedural risk and improve the patient's clinical status and prognosis. Per the ESC guidelines for surgical and interventional treatment of tricuspid regurgitation (2021 ESC/EACTS Guidelines for the Management of Valvular Heart Disease), Transcatheter intervention for symptomatic secondary severe TR may be considered in inoperable patients at a Heart Valve Centre with expertise in the treatment of tricuspid valve disease (Class IIb). 20 Transcatheter tricuspid treatment options can be divided into categories based on their mechanism of action: coaptation enhancement (edge-to-edge repair and spacer device), annuloplasty devices, caval valve implantation and valve replacement.

Study groups in NCT06568003
Study groupRoleWhat they receive
: LuX-Valve Plus transvenous tricuspid valve and delivery system(LuX-Valve Plus System)ExperimentalThe LuX-Valve Plus System is intended for the treatment of patients with severe TR who are determined by a Heart Team to be at high risk of traditional open-heart surgery.
Receives: Device: Transcatheter Tricuspid Valve Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Primary Outcome - Post-procedural TR Remission Rate

    Defined as: Post-procedural TR of moderate or less (TR≤2+) without clinically significant paravalvular leak (PVL) on a transthoracic echocardiography (TTE) at 30 days post- procedure (Assessed by the Echocardiography Core Lab using a 5-grade classification)

    Measured: at 30 days post procedure

  2. Primary Outcome - Incidence of major adverse events at 30 days post procedure

    A composite endpoint of Major Adverse Event (MAE) at 30 days post procedure, as listed below:

    • Cardiovascular Death
    • Myocardial Infarction (MI)
    • Stroke
    • New Onset Renal Failure Requiring Unplanned Dialysis or Hemofiltration
    • Major Bleeding (includes type 3b or higher as defined by Tricuspid Valve Academic Research Consortium [TVARC])
    • Tricuspid Valve Surgery or Transcatheter Re-intervention post Procedure
    • Major Access Site and Vascular Complications
    • Major Cardiac Complications
    • Device-related Pulmonary Embolism
    • New Pacemaker Implantation due to Atrioventricular (AV) Block

    Measured: at 30 days post procedure

Secondary outcomes (2)

  1. Acute Secondary Endpoints - Intraprocedural success Rate

    Subjects in whom all of the following were present were considered intraprocedural success, otherwise they were considered intraprocedural failure:

    • Absence of intraprocedural mortality or stroke; and
    • Successful access, delivery, and retrieval of the device delivery system
    • Successful deployment and correct positioning of the intended device without requiring implantation of unplanned additional device
    • Adequate performance of the transcatheter device. Absence of tricuspid stenosis (TVA ≥1.5cm2 or TVAi≥0.9cm2/m2), DVI<2.2, mean gradient <5mmHg; reduction of total tricuspid regurgitation to acceptable (moderate [2+])
    • Absence of device-related obstruction of forward flow
    • Absence of device-related pulmonary embolism
    • Freedom from emergency surgery or reintervention during the first 24h related to the device or access procedure

    Measured: the first 24h post-procedure

  2. Acute Secondary Endpoints - Clinical success Rate

    Subjects in whom all of the following were present were considered clinical success:

    • Absence of procedural mortality and stroke
    • Proper position of the device with adequate performance of the transcatheter device. Absence of tricuspid stenosis (TVA≥1.5cm2 or TVAi≥0.9cm2/m2), DVI<2.2, mean gradient<5mmHg; reduction of total tricuspid regurgitation to moderate [2+]
    • Freedom from unplanned surgical or interventional procedures related to the device or access procedure
    • Absence of MAEs, including:
    1. Life-threatening bleeding (TVARC 5)
    2. Major vascular complications
    3. Major cardiac structural complications
    4. Stage 2 or 3 acute kidney injury (includes new dialysis)
    5. Myocardial infarction or coronary ischemia requiring percutaneous coronary intervention or coronary artery bypass graft.
    6. Device-related obstruction of forward flow
    7. Device-related pulmonary embolism
    8. Hemodynamic compromise leading to heart transplantation or major cardiac

    Measured: at 30 days and at 1 year post-procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Aug 2024
  2. Study start26 Sep 2024
  3. Primary completion2 Oct 2025
  4. Study completionOct 2030 (estimated)

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
15 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06568003
Sponsor's protocol ID
JSNL-CIP-TVS02-01FDA
Status last verified
Feb 2026
First submitted
15 Aug 2024
Last updated
2 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Transcatheter Tricuspid Valve Intervention in people with Tricuspid Regurgitation (TR), run by Jenscare Innovation Inc. at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 2 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary Outcome - Post-procedural TR Remission Rate (time frame: at 30 days post procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06568003.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2026.

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