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

NCT06568003 | Active Not Recruiting DMC FDA Device

• 1 other identifier: JSNL-CIP-TVS02-01FDA
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 3

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).

Conditions

Tricuspid Regurgitation (TR)

Keywords

Tricuspid Regurgitation; Transvenous Tricuspid Replacement; LuX-Valve Plus System

Outcome Measures

Primary Outcomes (2)

• 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)

  at 30 days post procedure

• 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

  at 30 days post procedure

Secondary Outcomes (2)

• Acute Secondary Endpoints - Intraprocedural success Rate

  the first 24h post-procedure

• Acute Secondary Endpoints - Clinical success Rate

  at 30 days and at 1 year post-procedure

Study Arms (1)

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

EXPERIMENTAL

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.

Device: Transcatheter Tricuspid Valve Intervention

Interventions

Transcatheter Tricuspid Valve Intervention 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.

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jenscare Innovation Inc.: lead
• Cardiovascular Research Foundation, New York: collaborator

Study Sites (3)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

Montefiore Medical Center

New York, New York, 10467, United States

Location

MeSH Terms

Conditions

Tricuspid Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2024
• First Posted: August 23, 2024
• Study Start: September 26, 2024
• Primary Completion: October 2, 2025
• Study Completion (Estimated): October 1, 2030
• Last Updated: March 2, 2026

Record last verified: 2026-02

Locations

US (3)