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).
Brief Title
TraNsvenous TrIcuspid Valve ReplacemenT With LuX-Valve Plus System (TRINITY-US)
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.
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.
Completion Date
Completion Date Type
Estimated
Conditions
Tricuspid Regurgitation (TR)
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
* Anatomical inclusion criteria confirmed by echocardiographic core lab, CT core lab and Eligibility Committee
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
* 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 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
Inclusion 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
* Anatomical inclusion criteria confirmed by echocardiographic core lab, CT core lab and Eligibility Committee
* 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
Gender
All
Gender Based
false
Keywords
Tricuspid Regurgitation
Transvenous Tricuspid Replacement
LuX-Valve Plus System
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT06568003
Org Class
Industry
Org Full Name
Jenscare Innovation Inc.
Org Study Id
JSNL-CIP-TVS02-01FDA
Overall Status
Active, not recruiting
Phases
Not Applicable
Primary Completion Date
Primary Completion Date Type
Actual
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
Primary Outcomes
Outcome Description
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)
Outcome Measure
Primary Outcome - Post-procedural TR Remission Rate
Outcome Time Frame
at 30 days post procedure
Outcome Description
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
* 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
Outcome Measure
Primary Outcome - Incidence of major adverse events at 30 days post procedure
Outcome Time Frame
at 30 days post procedure
Secondary Outcomes
Outcome Description
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 procedure
* 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 procedure
Outcome Time Frame
the first 24h post-procedure
Outcome Measure
Acute Secondary Endpoints - Intraprocedural success Rate
Outcome Description
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
* 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
Outcome Time Frame
at 30 days and at 1 year post-procedure
Outcome Measure
Acute Secondary Endpoints - Clinical success Rate
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Mohamed Azeem Latib
Investigator Email
mlatib@montefiore.org
Investigator Phone
646-773-2076
Investigator Department
Medicine
Investigator Division
Cardiology
Investigator Sponsor Organization
Montefiore
Study Department
Medicine
Study Division
Cardiology
Categories Mesh Debug
Heart/Cardiovascular --- TRICUSPID VALVE INSUFFICIENCY
Heart/Cardiovascular --- HEART VALVE DISEASES
Brain, Spinal Cord & Nervous System --- HEART DISEASES
Heart/Cardiovascular --- HEART DISEASES
Blood Disorders --- CARDIOVASCULAR DISEASES
Heart/Cardiovascular --- CARDIOVASCULAR DISEASES
MeSH Terms
TRICUSPID VALVE INSUFFICIENCY
HEART VALVE DISEASES
HEART DISEASES
CARDIOVASCULAR DISEASES