Tricuspid RegurgitationTRI-SUCCESSNCT07919366
TRI-SUCCESS - Tricuspid Regurgitation Study of the Unica™ Cross-Caval System for the Evaluation of Efficacy and Safety in Significant TR Subjects
A study testing Innoventric Unica™ System in people with Tricuspid Regurgitation and Tricuspid Regurgitation Functional, run by Innoventric LTD.
Trial summary
Prospective, multi-center, randomized, open-label, controlled pivotal study to assess the safety and effectiveness of the Innoventric Unica™ heterotopic cross-caval stent with OMT compared to OMT alone in the treatment of severe or greater TR. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Tricuspid Regurgitation, Tricuspid Regurgitation Functional
- What is being tested?
- Innoventric Unica™ System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 510 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2027to 1 Jan 2035
- 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 ≤ Age ≤ 85
- Clinically symptomatic severe or greater tricuspid regurgitation
- Symptomatic (NYHA functional classification of II-IVa), despite OMT.
- The subject is deemed unsuitable for tricuspid valve surgery, tricuspid transcatheter edge-to-edge repair (t-TEER), or orthotopic transcatheter tricuspid valve replacement (TTVR), as determined by a multidisciplinary Heart Team.
- Peak central venous pressure or peak RA pressure of ≥ 12mmHg
- HF hospitalizations ≥ 1 in the past year
Who cannot join
- Echocardiographic parameters (Any of the following):
- LVEF < 30%
- Severe RV dysfunction
- Anatomical suitability according to CT scan
- Systolic Pulmonary Artery Pressure (measured per RHC) > 65mmHg or PVR >4 WU
- Moderate or greater tricuspid or mitral valve stenosis, or greater than moderate mitral valve regurgitation or greater than moderate aortic valve stenosis/regurgitation
Show all 19Show fewer
- Moderate mitral valve regurgitation combined with moderate aortic valve stenosis/regurgitation
- A Patent Foramen Ovale (PFO) or an Atrial Septal Defect (ASD) that cannot be closed.
- A Ventricular Septal Defect (VSD)
- 6MWD < 100m
- Any therapeutic invasive cardiac procedure (excluding PFO/ASD closure and pericardiocentesis for pericardial effusion drainage) in the 30 days prior to enrollment
- Kidney dysfunction with estimated Glomerular Filtration Rate (eGFR) < 30 ml/min/1.73 m2 within 60 days, or the subject is on chronic dialysis
- Liver cirrhosis or moderate or severe liver disease (Child-Turcotte Pugh class C)
- Chronic anemia (Hb < 8.5 g/dL) within 14 days
- Thrombocytopenia (platelet count< 80,000/mm3) or thrombocytosis (platelet count > 750,000/mm3) within 14 days
- Active or history of malignancy that, is likely to result in cancer related morbidity or mortality, require systemic anti-cancer therapy during the study follow-up period, or otherwise confound assessment of study endpoints.
- Current or history of drug or alcohol abuse within the last 3 years.
- Subject's life expectancy < 12 months
- Presence of any prosthetic device in the SVC or IVC or RA that prevents proper device implantation
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Prospective, multi-center, randomized, open-label, controlled pivotal study to assess the safety and effectiveness of the Innoventric Unica™ heterotopic cross-caval stent with OMT compared to OMT alone in the treatment of severe or greater TR.
Read the detailed description
Prospective, multi-center, randomized, open-label, controlled pivotal study to assess the safety and effectiveness of the Innoventric Unica™ heterotopic cross-caval stent with OMT compared to OMT alone in the treatment of severe or greater TR. A maximum of 510 subjects, may be enrolled at up to 70 sites in the US, Canada, Europe, and Israel. All enrolled study subjects will be assessed at baseline, after 1 month, 3 months, 6 months, and yearly thereafter through 5 years. The device cohort subjects will also be assessed during the procedure and at discharge.
- Being tested
- Innoventric Unica™ System
- Keywords
- Tricuspid valve, Transcatheter, Tricuspid Regurgitation, Tricuspid valve insufficiency
- 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.
Innoventric Unica™ SystemDevice
The Unica™ heterotopic cross-caval transcatheter tricuspid valve replacement in conjunction with Optimal Medical Therapy
| Study group | Role | What they receive |
|---|---|---|
| Device | Experimental | Unica™ System and OMT Receives: Device: Innoventric Unica™ System |
| Control | No intervention | OMT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Major Adverse Events (MAE)
Proportion of subjects experiencing a Major Adverse Event (MAE) in the device arm.
Measured: 30 Days
Reduction of at least one grade in Caval Reflux
Reduction of at least one grade in Caval Reflux assessed by the imaging core laboratory. The caval reflux will be assessed using the 3-grade scale
- 1- no reflux, reflux extending for less than 1 cm below the diaphragm (RA-IVC junction)
- 2- reflux extending for less than 3 cm from the diaphragm (RA-IVC junction)
- 3- reflux of 3 cm or more from the diaphragm (RA-IVC junction).
Measured: 6 months
Hierarchical Composite Endpoint including: improvement in KCCQ overall score, improvement in NYHA classification, improvement in 6MWD
Hierarchical Composite Endpoint analyzed using win-ratio - comparison of the number of wins between device and control arms
Measured: 6 months
Hierarchical Composite Endpoint including: all-cause mortality, RVAD implant or heart transplant, HF hospitalizations (total number), TR (re-)intervention, change in KCCQ-12 overall score, change in NYHA classification, change in 6MWD
Hierarchical Composite Endpoint analyzed using win-ratio - comparison of the number of wins between device and control arms
Measured: 1 Year
Secondary outcomes (15)
All-cause mortality
Measured: 1-year
Cardiovascular mortality
Measured: 1-year
Rate of HF hospitalizations
Measured: 1-year
Rate of HF hospitalizations combined with all-cause mortality
Measured: 1-year
Rate of HF hospitalizations combined with cardiovascular mortality
Measured: 1-year
Hierarchical composite endpoint consisting of all-cause death, RVAD implant or heart transplant, HF hospitalizations (total number), and TR (re-) intervention
Measured: 1-year
RVAD implant or heart transplant
Measured: 1-year
Tricuspid valve (re-)intervention
Time to tricuspid valve (re-)intervention
Measured: 1-year
Reduction in Caval Reflux assessed by the imaging core laboratory
Reduction of at least one grade in Caval Reflux assessed by the imaging core laboratory. The caval reflux will be assessed using the 3-grade scale
- 1- no reflux, reflux extending for less than 1 cm below the diaphragm (RA-IVC junction)
- 2- reflux extending for less than 3 cm from the diaphragm (RA-IVC junction)
- 3- reflux of 3 cm or more from the diaphragm (RA-IVC junction).
Measured: treatment, 30 days, 6 months, 1 year, 2 years, and 3 years
Reduction in CVP v-wave
Reduction in CVP v-wave measured by IVC catheterization
Measured: Treatment
Rate of Major Adverse Events (MAE)
Proportion of subjects experiencing a Major Adverse Event (MAE)
Measured: 1 year, 2 years, 3 years, 4 years, 5 years
Change in NYHA functional from baseline
Measured: 6 months, 1 year, and 2 years
Change in leg edema grade from baseline
Measured: 6 months, 1 year, and 2 years
Change in quality of life (QOL) as assessed by KCCQ-12 overall score from baseline
Measured: 6 months, 1 year, and 2 years
Change in 6MWD from baseline
Measured: 6 months, 1 year, and 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2026
- Study start1 Jan 2027 (estimated)
- Primary completion1 Jan 2031 (estimated)
- Study completion1 Jan 2035 (estimated)
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 510 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Innoventric LTD
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Innoventric Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07919366
- Sponsor's protocol ID
- CLD-U-101
- Acronym
- TRI-SUCCESS
- Status last verified
- Nov 2026
- First submitted
- 1 Nov 2026
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TRI-SUCCESS - Tricuspid Regurgitation Study of the Unica™ Cross-Caval System for the Evaluation of Efficacy and Safety in Significant TR Subjects
- ClinicalTrials.gov ID
- NCT07919366
- Acronym / sponsor ID
- TRI-SUCCESS / CLD-U-101
- Keywords
- Tricuspid valve, Transcatheter, Tricuspid Regurgitation, Tricuspid valve insufficiency
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 510 participants (estimated)
- Lead sponsor
- Innoventric LTDIndustry (pharma, biotech, devices)
- Collaborators
- Innoventric Inc.
- Study start
- 1 Jan 2027 (estimated)
- Primary completion
- 1 Jan 2031 (estimated)
- Study completion
- 1 Jan 2035 (estimated)
- First posted
- 5 Nov 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.
Prospective, multi-center, randomized, open-label, controlled pivotal study to assess the safety and effectiveness of the Innoventric Unica™ heterotopic cross-caval stent with OMT compared to OMT alone in the treatment of severe or greater TR.
Detailed description
Prospective, multi-center, randomized, open-label, controlled pivotal study to assess the safety and effectiveness of the Innoventric Unica™ heterotopic cross-caval stent with OMT compared to OMT alone in the treatment of severe or greater TR. A maximum of 510 subjects, may be enrolled at up to 70 sites in the US, Canada, Europe, and Israel. All enrolled study subjects will be assessed at baseline, after 1 month, 3 months, 6 months, and yearly thereafter through 5 years. The device cohort subjects will also be assessed during the procedure and at discharge.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Device | Experimental | Device: Innoventric Unica™ SystemUnica™ System and OMT |
| Control | No intervention | –OMT |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18 ≤ Age ≤ 85
- Clinically symptomatic severe or greater tricuspid regurgitation
- Symptomatic (NYHA functional classification of II-IVa), despite OMT.
- The subject is deemed unsuitable for tricuspid valve surgery, tricuspid transcatheter edge-to-edge repair (t-TEER), or orthotopic transcatheter tricuspid valve replacement (TTVR), as determined by a multidisciplinary Heart Team.
- Peak central venous pressure or peak RA pressure of ≥ 12mmHg
Key exclusion criteria (19 listed)
- Echocardiographic parameters (Any of the following):
- Anatomical suitability according to CT scan
- Systolic Pulmonary Artery Pressure (measured per RHC) > 65mmHg or PVR >4 WU
- Moderate or greater tricuspid or mitral valve stenosis, or greater than moderate mitral valve regurgitation or greater than moderate aortic valve stenosis/regurgitation
- Moderate mitral valve regurgitation combined with moderate aortic valve stenosis/regurgitation
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 |
|---|---|---|
| Innoventric Unica™ SystemThe Unica™ heterotopic cross-caval transcatheter tricuspid valve replacement in conjunction with Optimal Medical Therapy | Device | Device |
Primary outcome
Rate of Major Adverse Events (MAE)
Time frame: 30 Days
Proportion of subjects experiencing a Major Adverse Event (MAE) in the device arm.
Reduction of at least one grade in Caval Reflux
Time frame: 6 months
Reduction of at least one grade in Caval Reflux assessed by the imaging core laboratory. The caval reflux will be assessed using the 3-grade scale * 1- no reflux, reflux extending for less than 1 cm below the diaphragm (RA-IVC junction) * 2- reflux extending for less than 3 cm from the diaphragm (RA-IVC junction) * 3- reflux of 3 cm or more from the diaphragm (RA-IVC junction).
Hierarchical Composite Endpoint including: improvement in KCCQ overall score, improvement in NYHA classification, improvement in 6MWD
Time frame: 6 months
Hierarchical Composite Endpoint analyzed using win-ratio - comparison of the number of wins between device and control arms
Hierarchical Composite Endpoint including: all-cause mortality, RVAD implant or heart transplant, HF hospitalizations (total number), TR (re-)intervention, change in KCCQ-12 overall score, change in NYHA classification, change in 6MWD
Time frame: 1 Year
Hierarchical Composite Endpoint analyzed using win-ratio - comparison of the number of wins between device and control arms
15 secondary outcomes
All-cause mortality
Time frame: 1-year
Cardiovascular mortality
Time frame: 1-year
Rate of HF hospitalizations
Time frame: 1-year
Rate of HF hospitalizations combined with all-cause mortality
Time frame: 1-year
Rate of HF hospitalizations combined with cardiovascular mortality
Time frame: 1-year
Hierarchical composite endpoint consisting of all-cause death, RVAD implant or heart transplant, HF hospitalizations (total number), and TR (re-) intervention
Time frame: 1-year
RVAD implant or heart transplant
Time frame: 1-year
Tricuspid valve (re-)intervention
Time frame: 1-year
Reduction in Caval Reflux assessed by the imaging core laboratory
Time frame: treatment, 30 days, 6 months, 1 year, 2 years, and 3 years
Reduction in CVP v-wave
Time frame: Treatment
Rate of Major Adverse Events (MAE)
Time frame: 1 year, 2 years, 3 years, 4 years, 5 years
Change in NYHA functional from baseline
Time frame: 6 months, 1 year, and 2 years
Change in leg edema grade from baseline
Time frame: 6 months, 1 year, and 2 years
Change in quality of life (QOL) as assessed by KCCQ-12 overall score from baseline
Time frame: 6 months, 1 year, and 2 years
Change in 6MWD from baseline
Time frame: 6 months, 1 year, and 2 years
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 5 Nov 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.
Questions about this trial
What is this clinical trial studying?
A study testing Innoventric Unica™ System in people with Tricuspid Regurgitation and Tricuspid Regurgitation Functional, run by Innoventric LTD.
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 19 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: opening soon, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Chen Lereya, VP of Clinical Affairs (+972-528981783, chen@innoventric.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Major Adverse Events (MAE) (time frame: 30 Days). The study lists 4 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 5 Nov 2026.