TraNsvenous TrIcuspid Valve ReplacemenT with LuX-Valve Plus System (TRINITY-US)
- Conditions
- Tricuspid Regurgitation (TR)
- Interventions
- Device: Transcatheter Tricuspid Valve Intervention
- Registration Number
- NCT06568003
- Lead Sponsor
- Jenscare Innovation Inc.
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 15
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description : LuX-Valve Plus transvenous tricuspid valve and delivery system(LuX-Valve Plus System) Transcatheter Tricuspid Valve Intervention 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.
- Primary Outcome Measures
Name Time Method Primary Outcome - Incidence of major adverse events at 30 days post procedure 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) BlockPrimary Outcome - Post-procedural TR Remission Rate at 30 days post procedure 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)
- Secondary Outcome Measures
Name Time Method Acute Secondary Endpoints - Intraprocedural success Rate the first 24h post-procedure 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 procedureAcute Secondary Endpoints - Clinical success Rate at 30 days and at 1 year post-procedure 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
Trial Locations
- Locations (1)
Montefiore Medical Center
🇺🇸New York, New York, United States