- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05436028
A Study to Evaluate the Safety and Performance of LuX-Valve Plus System for Tricuspid Replacement
TRIal to Evaluate TraNsvenous TrIcuspid Valve ReplacemenT With LuX-Valve Plus System in Patients With Severe or Greater Tricuspid Regurgitation -- SafetY and Clinical Performance
This is a prospective, single-arm, multi-center trial to evaluate the LuX-Valve Plus system for treating symptomatic severe or greater TR in patients who are deemed high risk for tricuspid surgery.
Treatment with the LuX-Valve Plus system may enable patients with tricuspid regurgitation to have a complete tricuspid valve replacement with a minimally invasive approach.
A total of 93 subjects will be enrolled at up to 20 institutions worldwide. No single institution will be allowed to register more than 25% of total subjects. There is no minimum number of subjects to be registered at any site.
Up to an additional 42 roll-in subjects, up to 3 per site, may be enrolled by operators without prior experience with the LuX-Valve Plus system to gain hands-on experience. The data of roll-in subjects will not count towards the overall enrollment cap. Safety and effectiveness results of roll-in subjects will be reported separately.
All subjects will be evaluated at baseline, discharge, 30 days, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years post-procedure
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Lei Xia
- Phone Number: +8618514254641
- Email: xialei@jenscare.com
Study Contact Backup
- Name: Xing Li
- Phone Number: +8615720625797
- Email: lixing@jenscare.com
Study Locations
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Gironde
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Bordeaux, Gironde, France, 33000
- Recruiting
- Unité Médico-Chirurgicale, Hôpital Haut Lévêque, CHU de Bordeaux
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Contact:
- PASCUAL Zoé
- Phone Number: 05 24 54 93 70 (49370)
- Email: zoe.pascual@chu-bordeaux.fr
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Principal Investigator:
- Thomas Modine
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age≥50 years at time of consent
- Severe or greater TR (≥3+) assessed on transthoracic echocardiography by Echo Core Lab (ECL) using a 5-grade classification
- New York Heart Association (NYHA) Class III or IV
- In the judgment of the Site Heart Team, the subject has been adequately treated per applicable standards, including optimal medical therapy with diuretics
- The Site Heart Team determined that the subject is appropriate for transcatheter tricuspid valve replacement, and the subject is at high risk for tricuspid valve surgery
- Subject must provide written informed consent prior to any trial related procedure
Exclusion Criteria:
- Systolic pulmonary artery pressure (sPAP) > 60 mmHg assessed by echocardiography
- Left Ventricular Ejection Fraction (LVEF) <40%
- Evidence of intracardiac mass, thrombus or vegetation
- Anatomical structures precluding proper device deployment or device vascular access, evaluated by echo or CT
- Ebstein Anomaly or congenital right ventricular dysplasia
- Surgical correction is indicated for other concomitant valvular disease (e.g., severe aortic, mitral and/or pulmonic valve stenosis and/or regurgitation) Subjects with concomitant valvular disease may treat their respective valve first, and wait 2 months before being reassessed for the trial.
- Pre-existing prosthetic valve(s) with clinically significant prosthetic dysfunction
- Sepsis or active endocarditis within 3 months, or infections requiring antibiotic therapy within 2 weeks prior to the planned procedure
- Untreated clinically significant coronary artery disease requiring revascularization
- Acute myocardial infarction or unstable ischemia-related angina within prior 30 days
- Any percutaneous coronary, intracardiac or carotid intervention within 30 days
- Cerebrovascular stroke (ischemic or bleeding) within prior 3 months to enrollment
- Active peptic ulcer or active gastrointestinal (GI) bleeding within prior 3 months to enrollment
- Inability to tolerate anticoagulation or antiplatelet therapy
- Cardiogenic shock manifested by low cardiac output, vasopressor dependence, or mechanical hemodynamic support
- Renal insufficiency (eGFR < 30 ml/min per the Cockcroft-Gault formula) and/or renal replacement therapy at the time of screening
- Chronic liver failure or cirrhosis with MELD-Albumin Score ≥ 12
- Severe lung disease or patient dependent on home oxygen and deemed unsuitable by the local heart team or eligibility committee for the study.
- Futility with 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: LuX-Valve Plus transvenous tricuspid valve and delivery system(LuX-Valve Plus System)
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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
A composite endpoint of Major Adverse Event (MAE) at 30 days post procedure
Time Frame: 30 days post procedure
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A composite endpoint of Major Adverse Event (MAE) at 30 days post procedure, as listed below: Cardiovascular Mortality Myocardial Infarction (MI) Stroke New onset renal failure requiring unplanned dialysis or renal replacement therapy Severe Bleeding (includes fatal, life-threatening and extensive bleeding as defined by MVARC) Non-selective tricuspid valve surgery or transcatheter re-intervention post procedure Major cardiac structural complications Major access site and vascular complications New pacemaker implantation due to AV block |
30 days post procedure
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Acute Secondary Endpoints-Device Success Rate
Time Frame: From the first skin incision for the investigational device to the time patient's exist from OR/Cath lab,assessed up to 24 hours post procedure.
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Device success is defined as successful deployment of the device and removal of the delivery system as planned, with no unplanned surgery related to the device or access procedure.
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From the first skin incision for the investigational device to the time patient's exist from OR/Cath lab,assessed up to 24 hours post procedure.
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Acute Secondary Endpoints-Procedural Success Rate
Time Frame: 7-day post procedure, or at discharge if the subjects are discharged within 7 days after the procedure
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Device success without clinically significant PVL, as determined by the Echo Core Lab (ECL) assessment of a discharge TTE.
Subjects who die or undergo tricuspid valve surgery before discharge are procedure failures.
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7-day post procedure, or at discharge if the subjects are discharged within 7 days after the procedure
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Acute Secondary Endpoints-Clinical Success Rate at 30 days
Time Frame: at 30 days
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Procedural success without MAEs at 30 days.
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at 30 days
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Clinical and Functional Endpoints-All-cause mortality
Time Frame: at 30 days, 6 months, 12 months and annually until 5 years post-procedure
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All-cause mortality
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at 30 days, 6 months, 12 months and annually until 5 years post-procedure
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Clinical and Functional Endpoints-Cardiovascular mortality
Time Frame: at 30 days, 6 months, 12 months and annually until 5 years post-procedure
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Cardiovascular mortality
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at 30 days, 6 months, 12 months and annually until 5 years post-procedure
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Clinical and Functional Endpoints-Heart failure hospitalization
Time Frame: at 30 days, 6 months, 12 months and annually until 5 years post-procedure
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Heart failure hospitalization
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at 30 days, 6 months, 12 months and annually until 5 years post-procedure
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Clinical and Functional Endpoints-Tricuspid valve surgery or transcatheter re-intervention
Time Frame: at 30 days, 6 months, 12 months and annually until 5 years post-procedure
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Tricuspid valve surgery or transcatheter re-intervention
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at 30 days, 6 months, 12 months and annually until 5 years post-procedure
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Clinical and Functional Endpoints-NYHA Functional Class
Time Frame: at 30 days, 6 months, 12 months and annually until 5 years post-procedure
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NYHA Functional Class
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at 30 days, 6 months, 12 months and annually until 5 years post-procedure
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Clinical and Functional Endpoints-Distance of 6-Minute Walk Test (6MWT)
Time Frame: at 30 days, 6 months, 12 months and annually until 5 years post-procedure
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Distance of 6-Minute Walk Test (6MWT)
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at 30 days, 6 months, 12 months and annually until 5 years post-procedure
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Clinical and Functional Endpoints-Kansas City Cardiomyopathy Questionnaire (KCCQ)
Time Frame: at 30 days, 6 months, 12 months and annually until 5 years post-procedure
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Kansas City Cardiomyopathy Questionnaire (KCCQ):Scores are transformed to a range of 0-100,in which higher scores reflect better health status.
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at 30 days, 6 months, 12 months and annually until 5 years post-procedure
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Clinical and Functional Endpoints-Edema assessment
Time Frame: at 30 days, 6 months, 12 months and annually until 5 years post-procedure
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Edema assessment (1+ to 4+)
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at 30 days, 6 months, 12 months and annually until 5 years post-procedure
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Echocardiographic Endpoints-TR Severity Grade
Time Frame: at baseline, 7-day post procedure, or at discharge if the subjects are discharged within 7 days after the procedure, 30 days, 6 months, 12 months and annually until 5 years post-procedure
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TR Severity Grade
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at baseline, 7-day post procedure, or at discharge if the subjects are discharged within 7 days after the procedure, 30 days, 6 months, 12 months and annually until 5 years post-procedure
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Echocardiographic Endpoints-Vena Contracta Width
Time Frame: at baseline, 7-day post procedure, or at discharge if the subjects are discharged within 7 days after the procedure, 30 days, 6 months, 12 months and annually until 5 years post-procedure
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Vena Contracta Width
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at baseline, 7-day post procedure, or at discharge if the subjects are discharged within 7 days after the procedure, 30 days, 6 months, 12 months and annually until 5 years post-procedure
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Echocardiographic Endpoints-Regurgitation Jet Area
Time Frame: at baseline, 7-day post procedure, or at discharge if the subjects are discharged within 7 days after the procedure, 30 days, 6 months, 12 months and annually until 5 years post-procedure
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Regurgitation Jet Area
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at baseline, 7-day post procedure, or at discharge if the subjects are discharged within 7 days after the procedure, 30 days, 6 months, 12 months and annually until 5 years post-procedure
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Echocardiographic Endpoints-Effective Regurgitant Orifice Area (EROA)
Time Frame: at baseline, 7-day post procedure, or at discharge if the subjects are discharged within 7 days after the procedure, 30 days, 6 months, 12 months and annually until 5 years post-procedure
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Effective Regurgitant Orifice Area (EROA)
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at baseline, 7-day post procedure, or at discharge if the subjects are discharged within 7 days after the procedure, 30 days, 6 months, 12 months and annually until 5 years post-procedure
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Echocardiographic Endpoints-Regurgitant Volume
Time Frame: at baseline, 7-day post procedure, or at discharge if the subjects are discharged within 7 days after the procedure, 30 days, 6 months, 12 months and annually until 5 years post-procedure
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Regurgitant Volume
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at baseline, 7-day post procedure, or at discharge if the subjects are discharged within 7 days after the procedure, 30 days, 6 months, 12 months and annually until 5 years post-procedure
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Echocardiographic Endpoints-Mean Tricuspid valve inflow gradient
Time Frame: at baseline, 7-day post procedure, or at discharge if the subjects are discharged within 7 days after the procedure, 30 days, 6 months, 12 months and annually until 5 years post-procedure
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Mean Tricuspid valve inflow gradient
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at baseline, 7-day post procedure, or at discharge if the subjects are discharged within 7 days after the procedure, 30 days, 6 months, 12 months and annually until 5 years post-procedure
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Echocardiographic Endpoints-Right Atrial Volume
Time Frame: at baseline, 7-day post procedure, or at discharge if the subjects are discharged within 7 days after the procedure, 30 days, 6 months, 12 months and annually until 5 years post-procedure
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Right Atrial Volume
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at baseline, 7-day post procedure, or at discharge if the subjects are discharged within 7 days after the procedure, 30 days, 6 months, 12 months and annually until 5 years post-procedure
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Echocardiographic Endpoints-Right ventricular functions assessments:TAPSE
Time Frame: at baseline, 7-day post procedure, or at discharge if the subjects are discharged within 7 days after the procedure, 30 days, 6 months, 12 months and annually until 5 years post-procedure
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Right ventricular functions assessments:TAPSE
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at baseline, 7-day post procedure, or at discharge if the subjects are discharged within 7 days after the procedure, 30 days, 6 months, 12 months and annually until 5 years post-procedure
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Echocardiographic Endpoints-Right ventricular functions assessments:fractional area change(FAC)
Time Frame: at baseline, 7-day post procedure, or at discharge if the subjects are discharged within 7 days after the procedure, 30 days, 6 months, 12 months and annually until 5 years post-procedure
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Right ventricular functions assessments:fractional area change(FAC)
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at baseline, 7-day post procedure, or at discharge if the subjects are discharged within 7 days after the procedure, 30 days, 6 months, 12 months and annually until 5 years post-procedure
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Echocardiographic Endpoints-Right ventricular functions assessments:systolic tricuspid lateral annular tissue velocity S'
Time Frame: at baseline, 7-day post procedure, or at discharge if the subjects are discharged within 7 days after the procedure, 30 days, 6 months, 12 months and annually until 5 years post-procedure
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Right ventricular functions assessments:systolic tricuspid lateral annular tissue velocity S'
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at baseline, 7-day post procedure, or at discharge if the subjects are discharged within 7 days after the procedure, 30 days, 6 months, 12 months and annually until 5 years post-procedure
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Echocardiographic Endpoints-Right ventricular functions assessments:Hepatic vein flow reversal
Time Frame: at baseline, 7-day post procedure, or at discharge if the subjects are discharged within 7 days after the procedure, 30 days, 6 months, 12 months and annually until 5 years post-procedure
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Right ventricular functions assessments:Hepatic vein flow reversal
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at baseline, 7-day post procedure, or at discharge if the subjects are discharged within 7 days after the procedure, 30 days, 6 months, 12 months and annually until 5 years post-procedure
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Echocardiographic Endpoints-Right ventricular functions assessments:Inferior Cava Vein Diameter/respiratory variations
Time Frame: at baseline, 7-day post procedure, or at discharge if the subjects are discharged within 7 days after the procedure, 30 days, 6 months, 12 months and annually until 5 years post-procedure
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Right ventricular functions assessments:Inferior Cava Vein Diameter/respiratory variations
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at baseline, 7-day post procedure, or at discharge if the subjects are discharged within 7 days after the procedure, 30 days, 6 months, 12 months and annually until 5 years post-procedure
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Echocardiographic Endpoints-Systolic pulmonary artery pressure
Time Frame: at baseline, 7-day post procedure, or at discharge if the subjects are discharged within 7 days after the procedure, 30 days, 6 months, 12 months and annually until 5 years post-procedure
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Systolic pulmonary artery pressure
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at baseline, 7-day post procedure, or at discharge if the subjects are discharged within 7 days after the procedure, 30 days, 6 months, 12 months and annually until 5 years post-procedure
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Echocardiographic Endpoints-Cardiac Output
Time Frame: at baseline, 7-day post procedure, or at discharge if the subjects are discharged within 7 days after the procedure, 30 days, 6 months, 12 months and annually until 5 years post-procedure
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Cardiac Output
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at baseline, 7-day post procedure, or at discharge if the subjects are discharged within 7 days after the procedure, 30 days, 6 months, 12 months and annually until 5 years post-procedure
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Echocardiographic Endpoints-Left Ventricular Ejection Fraction (LVEF)
Time Frame: at baseline, 7-day post procedure, or at discharge if the subjects are discharged within 7 days after the procedure, 30 days, 6 months, 12 months and annually until 5 years post-procedure
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Left Ventricular Ejection Fraction (LVEF)
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at baseline, 7-day post procedure, or at discharge if the subjects are discharged within 7 days after the procedure, 30 days, 6 months, 12 months and annually until 5 years post-procedure
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Echocardiographic Endpoints-Paravalvular leak severity
Time Frame: at baseline, 7-day post procedure, or at discharge if the subjects are discharged within 7 days after the procedure, 30 days, 6 months, 12 months and annually until 5 years post-procedure
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Paravalvular leak severity
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at baseline, 7-day post procedure, or at discharge if the subjects are discharged within 7 days after the procedure, 30 days, 6 months, 12 months and annually until 5 years post-procedure
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- JSNL-CIP-TVS02-01CE
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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