Tricuspid RegurgitationNCT05436028
A Study to Evaluate the Safety and Performance of LuX-Valve Plus System for Tricuspid Replacement
A study testing Transcatheter Tricuspid Valve Intervention in people with Tricuspid Regurgitation, run by Jenscare Scientific at 1 site in France.
Trial summary
This is a prospective, single-arm, multi-center trial to evaluate the LuX-Valve Plus system for treating symptomatic at least severe TR in patients who are deemed high risk for tricuspid surgery. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Tricuspid Regurgitation
- What is being tested?
- Transcatheter Tricuspid Valve Intervention
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 161 participants
- Where
- 1 siteFrance
- Study dates
- 23 May 2023to 30 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 II-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 concur the benefit-risk analysis supports transcatheter tricuspid valve replacement per current guidelines for the management of valvular heart disease, and the subject is at high risk for tricuspid valve surgery.
- 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
- In France, patient is affiliated to a health social security regimen or equivalent
Who cannot join
- Pulmonary arterial systolic pressure (PASP) > 60 mmHg by echo Doppler (unless right heart catheterization [RHC] demonstrates PASP ≤60 mmHg) or R 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.
- Left Ventricular Ejection Fraction (LVEF) <35%
- 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.
Show all 23Show fewer
- Patients with valve prostheses implanted in the tricuspid valve
- Pre-existing prosthetic valve(s) (other than tricuspid ones) 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 30 days prior to the planned procedure
- Any percutaneous coronary, intracardiac or carotid intervention within 30 days prior to the planned procedure
- 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.
- Pregnant or lactating; or female of childbearing potential with a positive pregnancy test within 14 days prior to intervention (contraceptive requirement is shown in Appendix XI)
- Allergic to one or more of the substances contained in the implant and/or delivery system, including nitinol, tantalum, PET, PTFE, bovine pericardium, Pebax, PA, Polyurethane, Stainless steel.
Trial locations and contacts
1 site in 1 country.
France1 site
Unité Médico-Chirurgicale, Hôpital Haut Lévêque, CHU de Bordeaux
Bordeaux, Gironde, 33000
About this study
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
This is a prospective, single-arm, multi-center trial to evaluate the LuX-Valve Plus system for treating symptomatic at least severe 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.
Read more
Up to 150 subjects will be implanted at up to 24 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 to3 per site, may be implanted by operators without prior experience using the LuX-Valve Plus device to gain hands-on experience.Each site has a maximum of 3 roll-in cases. The data of roll-in subjects will not count towards the overall enrollment cap. Safety and performance results of roll-in subjects will be analyzed in subgroups.
All subjects will be evaluated at baseline, procedure, discharge, 30 days, 6 months, 1 year, 2 years, 3 years, 4 years, and 5 years post-procedure.
- Conditions
- Tricuspid Regurgitation
- Being tested
- Transcatheter Tricuspid Valve Intervention
- Medical subject headings
- Tricuspid Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcatheter Tricuspid Valve InterventionDevice
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).
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.
| Study group | Role | What they receive |
|---|---|---|
| LuX-Valve Plus transvenous tricuspid valve and delivery system（LuX-Valve Plus System） | Experimental | The LuX-Valve Plus System is intended for the treatment of patients with at least severe TR who are determined by a Heart Team to be at high risk of traditional open-heart surgery. Receives: Device: Transcatheter Tricuspid Valve Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
A composite endpoint of Major Adverse Event (MAE) at 30 days post procedure
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 Device-related pulmonary embolism New pacemaker implantation due to AV block
Measured: 30 days post procedure
Secondary outcomes (27)
Acute Secondary Endpoints-Device Success Rate
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.
Measured: 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.
Acute Secondary Endpoints-Procedural Success Rate
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.
Measured: 7-day post procedure, or at discharge if the subjects are discharged within 7 days after the procedure
Acute Secondary Endpoints-Clinical Success Rate at 30 days
Procedural success without MAEs at 30 days.
Measured: at 30 days
Clinical and Functional Endpoints-All-cause mortality
All-cause mortality
Measured: at 30 days, 6 months, 12 months and annually until 5 years post-procedure
Clinical and Functional Endpoints-Cardiovascular mortality
Cardiovascular mortality
Measured: at 30 days, 6 months, 12 months and annually until 5 years post-procedure
Clinical and Functional Endpoints-Heart failure hospitalization
Heart failure hospitalization
Measured: at 30 days, 6 months, 12 months and annually until 5 years post-procedure
Clinical and Functional Endpoints-Tricuspid valve surgery or transcatheter re-intervention
Tricuspid valve surgery or transcatheter re-intervention
Measured: at 30 days, 6 months, 12 months and annually until 5 years post-procedure
Clinical and Functional Endpoints-NYHA Functional Class
NYHA Functional Class
Measured: at 30 days, 6 months, 12 months and annually until 5 years post-procedure
Clinical and Functional Endpoints-Distance of 6-Minute Walk Test (6MWT)
Distance of 6-Minute Walk Test (6MWT)
Measured: at 30 days, 6 months, 12 months and annually until 5 years post-procedure
Clinical and Functional Endpoints-Kansas City Cardiomyopathy Questionnaire (KCCQ)
Kansas City Cardiomyopathy Questionnaire (KCCQ)：Scores are transformed to a range of 0-100,in which higher scores reflect better health status.
Measured: at 30 days, 6 months, 12 months and annually until 5 years post-procedure
Clinical and Functional Endpoints-Edema assessment
Edema assessment (1+ to 4+)
Measured: at 30 days, 6 months, 12 months and annually until 5 years post-procedure
Echocardiographic Endpoints-TR Severity Grade
TR Severity Grade
Measured: 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
Echocardiographic Endpoints-Vena Contracta Width
Vena Contracta Width
Measured: 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
Echocardiographic Endpoints-Regurgitation Jet Area
Regurgitation Jet Area
Measured: 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
Echocardiographic Endpoints-Effective Regurgitant Orifice Area (EROA)
Effective Regurgitant Orifice Area (EROA)
Measured: 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
Echocardiographic Endpoints-Regurgitant Volume
Regurgitant Volume
Measured: 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
Echocardiographic Endpoints-Mean Tricuspid valve inflow gradient
Mean Tricuspid valve inflow gradient
Measured: 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
Echocardiographic Endpoints-Right Atrial Volume
Right Atrial Volume
Measured: 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
Echocardiographic Endpoints-Right ventricular functions assessments:TAPSE
Right ventricular functions assessments:TAPSE
Measured: 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
Echocardiographic Endpoints-Right ventricular functions assessments:fractional area change（FAC）
Right ventricular functions assessments:fractional area change（FAC）
Measured: 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
Echocardiographic Endpoints-Right ventricular functions assessments:systolic tricuspid lateral annular tissue velocity S'
Right ventricular functions assessments:systolic tricuspid lateral annular tissue velocity S'
Measured: 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
Echocardiographic Endpoints-Right ventricular functions assessments:Hepatic vein flow reversal
Right ventricular functions assessments:Hepatic vein flow reversal
Measured: 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
Echocardiographic Endpoints-Right ventricular functions assessments:Inferior Cava Vein Diameter/respiratory variations
Right ventricular functions assessments:Inferior Cava Vein Diameter/respiratory variations
Measured: 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
Echocardiographic Endpoints-Systolic pulmonary artery pressure
Systolic pulmonary artery pressure
Measured: 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
Echocardiographic Endpoints-Cardiac Output
Cardiac Output
Measured: 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
Echocardiographic Endpoints-Left Ventricular Ejection Fraction (LVEF)
Left Ventricular Ejection Fraction (LVEF)
Measured: 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
Echocardiographic Endpoints-Paravalvular leak severity
Paravalvular leak severity
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2022
- Study start23 May 2023
- Primary completion30 Nov 2024
- Study completion30 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tricuspid RegurgitationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 161 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jenscare Scientific
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05436028
- Sponsor's protocol ID
- JSNL-CIP-TVS02-01CE
- Status last verified
- May 2025
- First submitted
- 8 Jun 2022
- Last updated
- 21 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05436028
- Acronym / sponsor ID
- JSNL-CIP-TVS02-01CE
- Conditions
- Tricuspid Regurgitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 161 participants (actual)
- Lead sponsor
- Jenscare ScientificIndustry (pharma, biotech, devices)
- Study start
- 23 May 2023 (actual)
- Primary completion
- 30 Nov 2024 (actual)
- Study completion
- 30 Nov 2024 (actual)
- First posted
- 28 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective, single-arm, multi-center trial to evaluate the LuX-Valve Plus system for treating symptomatic at least severe 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.
Up to 150 subjects will be implanted at up to 24 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 to3 per site, may be implanted by operators without prior experience using the LuX-Valve Plus device to gain hands-on experience.Each site has a maximum of 3 roll-in cases. The data of roll-in subjects will not count towards the overall enrollment cap. Safety and performance results of roll-in subjects will be analyzed in subgroups.
All subjects will be evaluated at baseline, procedure, discharge, 30 days, 6 months, 1 year, 2 years, 3 years, 4 years, and 5 years post-procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LuX-Valve Plus transvenous tricuspid valve and delivery system（LuX-Valve Plus System） | Experimental | Device: Transcatheter Tricuspid Valve InterventionThe LuX-Valve Plus System is intended for the treatment of patients with at least severe TR who are determined by a Heart Team to be at high risk of traditional open-heart surgery. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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 II-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 concur the benefit-risk analysis supports transcatheter tricuspid valve replacement per current guidelines for the management of valvular heart disease, and the subject is at high risk for tricuspid valve surgery.
Key exclusion criteria (23 listed)
- Pulmonary arterial systolic pressure (PASP) > 60 mmHg by echo Doppler (unless right heart catheterization [RHC] demonstrates PASP ≤60 mmHg) or R 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.
- Left Ventricular Ejection Fraction (LVEF) <35%
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcatheter Tricuspid Valve InterventionDue 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). 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. | Device | LuX-Valve Plus transvenous tricuspid valve and delivery system（LuX-Valve Plus System） |
Primary outcome
A composite endpoint of Major Adverse Event (MAE) at 30 days post procedure
Time frame: 30 days post procedure
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 Device-related pulmonary embolism New pacemaker implantation due to AV block
27 secondary outcomes
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.
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
Acute Secondary Endpoints-Clinical Success Rate at 30 days
Time frame: at 30 days
Clinical and Functional Endpoints-All-cause mortality
Time frame: at 30 days, 6 months, 12 months and annually until 5 years post-procedure
Clinical and Functional Endpoints-Cardiovascular mortality
Time frame: at 30 days, 6 months, 12 months and annually until 5 years post-procedure
Clinical and Functional Endpoints-Heart failure hospitalization
Time frame: at 30 days, 6 months, 12 months and annually until 5 years post-procedure
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
Clinical and Functional Endpoints-NYHA Functional Class
Time frame: at 30 days, 6 months, 12 months and annually until 5 years post-procedure
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
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
Clinical and Functional Endpoints-Edema assessment
Time frame: at 30 days, 6 months, 12 months and annually until 5 years post-procedure
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcatheter Tricuspid Valve Intervention in people with Tricuspid Regurgitation, run by Jenscare Scientific at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A composite endpoint of Major Adverse Event (MAE) at 30 days post procedure (time frame: 30 days post procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2025.