ACTIVE_NOT_RECRUITING

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

Conditions

Tricuspid Regurgitation (TR)Tricuspid Regurgitation Transvenous Tricuspid Replacement LuX-Valve Plus System

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

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

Quick Facts

Study Start:2024-09-26

Study Completion:2030-10

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06568003

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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 * Anatomical inclusion criteria confirmed by echocardiographic core lab, CT core lab and Eligibility Committee	* 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

Inclusion Criteria

Exclusion 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
* Anatomical inclusion criteria confirmed by echocardiographic core lab, CT core lab and Eligibility Committee

* 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

Contacts and Locations

Study Locations (Sites)

Cedars-Sinai Medical Center

Los Angeles, California, 90048

United States

Henry Ford Health System

Detroit, Michigan, 48202

United States

Montefiore Medical Center

New York, New York, 10467

United States

Collaborators and Investigators

Sponsor: Jenscare Innovation Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-09-26

Study Completion Date2030-10

Study Record Updates

Study Start Date2024-09-26

Study Completion Date2030-10

Terms related to this study

Keywords Provided by Researchers

Tricuspid Regurgitation
Transvenous Tricuspid Replacement
LuX-Valve Plus System

Additional Relevant MeSH Terms

Tricuspid Regurgitation (TR)