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

NCT ID: NCT06568003

Last Updated: 2025-10-20

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-26
• Study Completion Date: 2030-10-31

Brief 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. 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).

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:

o 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

o JS/TTVDJ-33

• Introducer Kit

o 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.

Conditions

Tricuspid Regurgitation (TR)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

: LuX-Valve Plus transvenous tricuspid valve and delivery system(LuX-Valve Plus System)

The 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.

Group Type: EXPERIMENTAL

Transcatheter Tricuspid Valve Intervention

Intervention Type: DEVICE

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.

Interventions

Transcatheter Tricuspid Valve Intervention

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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

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); 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
• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cardiovascular Research Foundation, New York

OTHER

Sponsor Role: collaborator

Jenscare Innovation Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Cedars-Sinai Medical Center

Los Angeles, California, United States

Henry Ford Health System

Detroit, Michigan, United States

Montefiore Medical Center

New York, New York, United States

Countries

United States

Other Identifiers

JSNL-CIP-TVS02-01FDA

Identifier Type: -

Identifier Source: org_study_id