Tricuspid Regurgitation (TR)NCT07705594
LuX-Valve Plus System for Severe or Greater Tricuspid Regurgitation
A study testing Transvenous Tricuspid Valve System implantation + OMT and OMT in people with Tricuspid Regurgitation (TR), run by Jenscare Scientific at 1 site in China.
Trial summary
This clinical trial aims to evaluate the safety and effectiveness of the Transvenous Artificial Tricuspid Valve System, LuX-Valve Plus System, Jenscare Scientific Co., Ltd. The study population consists of high-risk patients with severe or greater tricuspid regurgitation (TR) who are ineligible for surgical… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Tricuspid Regurgitation (TR)
- What is being tested?
- Transvenous Tricuspid Valve System implantation + OMT and OMT
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteChina
- Study dates
- 9 Oct 2024to 6 Aug 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age ≥ 65 years
- Severe or greater TR (TR ≥ 3+ / 4+ by echocardiography)
- High surgical risk or inoperable per heart team (TRI-SCORE ≥6, STS ≥8%, EuroSCORE II ≥3%, etc.) AND symptomatic despite GDMT (≥1 month diuretics, stable regimen for ≥2 weeks)
- Suitable for TTVR per heart team
- NYHA III-IV
- Signed ICF and willing to comply with follow-up
Who cannot join
- Anatomy unsuitable for device procedure
- LVEF < 50%
- SPAP > 60 mmHg by TTE (unless RHC confirms ≤60 mmHg)
- Aortic/mitral/pulmonary valve disease requiring surgery
- Prosthetic valve replacement within 6 months or moderate/severe dysfunction
- Ebstein anomaly or RV dysplasia
Show all 22Show fewer
- RVOT obstruction or intracardiac mass
- Active endocarditis within 90 days, or antibiotics for infection within 14 days
- CV/cardiac/cervical surgery within 30 days
- Stroke within 90 days
- Unable to tolerate anticoagulation/antiplatelet therapy
- eGFR < 30 mL/min/1.73m² or on RRT
- MELD-Albumin ≥ 12
- Severe respiratory dysfunction (unsuitable for general anesthesia)
- Active GI bleeding/ulcer within 90 days
- Cardiogenic shock or hemodynamic instability within 30 days
- Untreated severe CAD or ACS within 30 days
- Life expectancy ≤ 1 year
- Known allergy to device components or study drugs
- Pregnancy or lactation (or planned pregnancy)
- Enrolled in another interventional trial (not reached primary endpoint)
- Other conditions deemed unsuitable per investigator
Trial locations and contacts
1 site in 1 country.
China1 site
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200032
About this study
Official title: A Prospective, Multicenter, Randomized Controlled Clinical Trial to Evaluate the Safety and Efficacy of a Transvenous Artificial Tricuspid Valve System in Patients With Severe or Greater Tricuspid Regurgitation
This clinical trial aims to evaluate the safety and effectiveness of the Transvenous Artificial Tricuspid Valve System, LuX-Valve Plus System, Jenscare Scientific Co., Ltd. The study population consists of high-risk patients with severe or greater tricuspid regurgitation (TR) who are ineligible for surgical intervention and have demonstrated inadequate response to optimized medical therapy (OMT).
This is a prospective, multicenter, randomized controlled trial. A total of 111 subjects who meet all inclusion criteria and none of the exclusion criteria will be enrolled. Participants will be randomized in a 2:1 ratio to one of the following groups:
Read more
Treatment Group: Transvenous Artificial Tricuspid Valve System implantation + OMT Control Group: OMT alone
All subjects will undergo serial follow-up assessments pre-treatment, during the treatment period, and post-procedure at 30 days, 3 months, 6 months, 1 year, and annually through 2-5 years. A summary report will be submitted to the regulatory authority at the 6-month time point.
Subjects in the treatment group will have one extra follow-up visit at 7 days ± 3 days post-procedure or prior to discharge (whichever occurs first).
- Conditions
- Tricuspid Regurgitation (TR)
- Being tested
- Transvenous Tricuspid Valve System implantation + OMT, OMT
- Keywords
- Tricuspid Regurgitation (TR), Transcatheter tricuspid valve replacement, TTVR
- 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.
Transvenous Tricuspid Valve System implantation + OMTDevice
Transvenous tricuspid valve replacement with Lux-Valve Plus System in patients with severe or greater Tricuspid Regurgitation despite optimal medical therapy (OMT)
OMTDrug
Optimal medical therapy (OMT) as the control group for patients with severe or greater tricuspid regurgitation
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | LuX-Valve Plus System+OMT Receives: Device: Transvenous Tricuspid Valve System implantation + OMT |
| Control Group | Other | OMT only Receives: Drug: OMT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence rate of composite endpoint events
Percentage (%) of participants achieving composite clinical success at 6 months. Composite clinical success is defined as meeting all of the following criteria:
- Alive;
- No heart failure rehospitalization;
- Reduction in tricuspid regurgitation severity by ≥1 grade from baseline;
- Improvement in New York Heart Association (NYHA) functional class by ≥1 class from baseline.
Measured: 6 months post-treatment
Rate of Major Adverse Events (MAE)
The major adverse event (MAE) rate is defined as the occurrence of any of the following:
Cardiac death
Myocardial infarction
Stroke
New-onset renal failure requiring renal replacement therapy after the procedure
Major bleeding (Grade ≥3b according to TVARC)
Tricuspid valve re-intervention
Device puncture site and vascular access complications
Major cardiac structural complications
Device-related pulmonary embolism
Arrhythmia or conduction block requiring permanent pacemaker implantation
Measured: 30 Day Post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2026
- Study start9 Oct 2024
- Primary completion6 Mar 2026
- Study completion6 Aug 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tricuspid Regurgitation (TR)Studies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 126 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
- NCT07705594
- Sponsor's protocol ID
- CP-TVS02-C2401
- Status last verified
- Jul 2026
- First submitted
- 7 Jul 2026
- Last updated
- 15 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Randomized Controlled Clinical Trial to Evaluate the Safety and Efficacy of a Transvenous Artificial Tricuspid Valve System in Patients With Severe or Greater Tricuspid Regurgitation
- ClinicalTrials.gov ID
- NCT07705594
- Acronym / sponsor ID
- CP-TVS02-C2401
- Conditions
- Tricuspid Regurgitation (TR)
- Keywords
- Tricuspid Regurgitation (TR), Transcatheter tricuspid valve replacement, TTVR
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Jenscare ScientificIndustry (pharma, biotech, devices)
- Study start
- 9 Oct 2024 (actual)
- Primary completion
- 6 Mar 2026 (actual)
- Study completion
- 6 Aug 2030 (estimated)
- First posted
- 15 Jul 2026 (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 clinical trial aims to evaluate the safety and effectiveness of the Transvenous Artificial Tricuspid Valve System, LuX-Valve Plus System, Jenscare Scientific Co., Ltd. The study population consists of high-risk patients with severe or greater tricuspid regurgitation (TR) who are ineligible for surgical intervention and have demonstrated inadequate response to optimized medical therapy (OMT).
This is a prospective, multicenter, randomized controlled trial. A total of 111 subjects who meet all inclusion criteria and none of the exclusion criteria will be enrolled. Participants will be randomized in a 2:1 ratio to one of the following groups:
Treatment Group: Transvenous Artificial Tricuspid Valve System implantation + OMT Control Group: OMT alone
All subjects will undergo serial follow-up assessments pre-treatment, during the treatment period, and post-procedure at 30 days, 3 months, 6 months, 1 year, and annually through 2-5 years. A summary report will be submitted to the regulatory authority at the 6-month time point.
Subjects in the treatment group will have one extra follow-up visit at 7 days ± 3 days post-procedure or prior to discharge (whichever occurs first).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Device: Transvenous Tricuspid Valve System implantation + OMTLuX-Valve Plus System+OMT |
| Control Group | Other | Drug: OMTOMT only |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- Age ≥ 65 years
- Severe or greater TR (TR ≥ 3+ / 4+ by echocardiography)
- High surgical risk or inoperable per heart team (TRI-SCORE ≥6, STS ≥8%, EuroSCORE II ≥3%, etc.) AND symptomatic despite GDMT (≥1 month diuretics, stable regimen for ≥2 weeks)
- Suitable for TTVR per heart team
- NYHA III-IV
Key exclusion criteria (22 listed)
- Anatomy unsuitable for device procedure
- LVEF < 50%
- SPAP > 60 mmHg by TTE (unless RHC confirms ≤60 mmHg)
- Aortic/mitral/pulmonary valve disease requiring surgery
- Prosthetic valve replacement within 6 months or moderate/severe dysfunction
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 |
|---|---|---|
| Transvenous Tricuspid Valve System implantation + OMTTransvenous tricuspid valve replacement with Lux-Valve Plus System in patients with severe or greater Tricuspid Regurgitation despite optimal medical therapy (OMT) | Device | Treatment Group |
| OMTOptimal medical therapy (OMT) as the control group for patients with severe or greater tricuspid regurgitation | Drug | Control Group |
Primary outcome
Incidence rate of composite endpoint events
Time frame: 6 months post-treatment
Percentage (%) of participants achieving composite clinical success at 6 months. Composite clinical success is defined as meeting all of the following criteria: 1. Alive; 2. No heart failure rehospitalization; 3. Reduction in tricuspid regurgitation severity by ≥1 grade from baseline; 4. Improvement in New York Heart Association (NYHA) functional class by ≥1 class from baseline.
Rate of Major Adverse Events (MAE)
Time frame: 30 Day Post-treatment
The major adverse event (MAE) rate is defined as the occurrence of any of the following: Cardiac death Myocardial infarction Stroke New-onset renal failure requiring renal replacement therapy after the procedure Major bleeding (Grade ≥3b according to TVARC) Tricuspid valve re-intervention Device puncture site and vascular access complications Major cardiac structural complications Device-related pulmonary embolism Arrhythmia or conduction block requiring permanent pacemaker implantation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2026.
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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 Transvenous Tricuspid Valve System implantation + OMT and OMT in people with Tricuspid Regurgitation (TR), run by Jenscare Scientific at 1 site in China.
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 6 inclusion and 22 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: under way, not looking for participants, as of the sponsor's last update on 15 Jul 2026. 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 China. 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?
This study is still under way. Results are not available in the source record yet.
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?
Incidence rate of composite endpoint events (time frame: 6 months post-treatment). The study lists 2 primary outcomes in all. 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 15 Jul 2026.