An interventional study of Innoventric Unica™ System in Tricuspid Regurgitation and Tricuspid Regurgitation Functional, sponsored by Innoventric LTD. Not yet recruiting. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-11-05.
Sponsored by Innoventric LTD · Not applicable, Interventional, and Treatment
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.
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.
226 studies on the registry are indexed under Tricuspid Valve Insufficiency; 109 are open to participants now.
This study's planned enrollment of 510 is above the median of 60 across 128 interventional studies indexed under Tricuspid Valve Insufficiency.
Browse Tricuspid Valve Insufficiency studies →Innoventric LTD is the lead sponsor of 3 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Echocardiographic parameters (Any of the following):
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Unica™ System and OMT
Device: Innoventric Unica™ System
OMT
The Unica™ heterotopic cross-caval transcatheter tricuspid valve replacement in conjunction with Optimal Medical Therapy
Rate of Major Adverse Events (MAE)
Proportion of subjects experiencing a Major Adverse Event (MAE) in the device arm.
Time frame: 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).
Time frame: 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
Time frame: 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
Time frame: 1 Year
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 to tricuspid valve (re-)intervention
Time frame: 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).
Time frame: 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
Time frame: Treatment
Rate of Major Adverse Events (MAE)
Proportion of subjects experiencing a Major Adverse Event (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
No study locations are listed for this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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