Status:
ACTIVE_NOT_RECRUITING
TraNsvenous TrIcuspid Valve ReplacemenT With LuX-Valve Plus System (TRINITY-US)
Lead Sponsor:
Jenscare Innovation Inc.
Collaborating Sponsors:
Cardiovascular Research Foundation, New York
Conditions:
Tricuspid Regurgitation (TR)
Eligibility:
All Genders
18+ years
Phase:
NA
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 aim...
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
September 26 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2030
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT06568003
Start Date
September 26 2024
End Date
October 1 2030
Last Update
October 20 2025
Active Locations (3)
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1
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
2
Henry Ford Health System
Detroit, Michigan, United States, 48202
3
Montefiore Medical Center
New York, New York, United States, 10467