TRI-SUCCESS - Tricuspid Regurgitation Study of the Unica™ Cross-Caval System for the Evaluation of Efficacy and Safety in Significant TR Subjects
NCT07919366, Not applicable, Not yet recruiting, Innoventric LTD
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| 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 |
| NCT number | NCT07919366 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 510 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Innoventric LTD | ClinicalTrials.gov |
| Conditions | Tricuspid Regurgitation, Tricuspid Regurgitation Functional | ClinicalTrials.gov |
| Interventions | Innoventric Unica™ System | ClinicalTrials.gov |
| First posted | 2026-11-05 | ClinicalTrials.gov |
| Last updated | 2026-11-05 | ClinicalTrials.gov |
Registered outcomes 19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Rate of Major Adverse Events (MAE) | 30 Days | Proportion of subjects experiencing a Major Adverse Event (MAE) in the device arm. | ClinicalTrials.gov |
| Primary | Reduction of at least one grade in Caval Reflux | 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). | ClinicalTrials.gov |
| Primary | Hierarchical Composite Endpoint including: improvement in KCCQ overall score, improvement in NYHA classification, improvement in 6MWD | 6 months | Hierarchical Composite Endpoint analyzed using win-ratio - comparison of the number of wins between device and control arms | ClinicalTrials.gov |
| Primary | 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 | 1 Year | Hierarchical Composite Endpoint analyzed using win-ratio - comparison of the number of wins between device and control arms | ClinicalTrials.gov |
| Secondary | All-cause mortality | 1-year | ClinicalTrials.gov | |
| Secondary | Cardiovascular mortality | 1-year | ClinicalTrials.gov | |
| Secondary | Rate of HF hospitalizations | 1-year | ClinicalTrials.gov | |
| Secondary | Rate of HF hospitalizations combined with all-cause mortality | 1-year | ClinicalTrials.gov | |
| Secondary | Rate of HF hospitalizations combined with cardiovascular mortality | 1-year | ClinicalTrials.gov | |
| Secondary | Hierarchical composite endpoint consisting of all-cause death, RVAD implant or heart transplant, HF hospitalizations (total number), and TR (re-) intervention | 1-year | ClinicalTrials.gov | |
| Secondary | RVAD implant or heart transplant | 1-year | ClinicalTrials.gov | |
| Secondary | Tricuspid valve (re-)intervention | 1-year | Time to tricuspid valve (re-)intervention | ClinicalTrials.gov |
| Secondary | Reduction in Caval Reflux assessed by the imaging core laboratory | treatment, 30 days, 6 months, 1 year, 2 years, and 3 years | 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). | ClinicalTrials.gov |
| Secondary | Reduction in CVP v-wave | Treatment | Reduction in CVP v-wave measured by IVC catheterization | ClinicalTrials.gov |
| Secondary | Rate of Major Adverse Events (MAE) | 1 year, 2 years, 3 years, 4 years, 5 years | Proportion of subjects experiencing a Major Adverse Event (MAE) | ClinicalTrials.gov |
| Secondary | Change in NYHA functional from baseline | 6 months, 1 year, and 2 years | ClinicalTrials.gov | |
| Secondary | Change in leg edema grade from baseline | 6 months, 1 year, and 2 years | ClinicalTrials.gov | |
| Secondary | Change in quality of life (QOL) as assessed by KCCQ-12 overall score from baseline | 6 months, 1 year, and 2 years | ClinicalTrials.gov | |
| Secondary | Change in 6MWD from baseline | 6 months, 1 year, and 2 years | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)