Tricuspid Regurgitation
Conditions
Keywords
Tricuspid Valve, Tricuspid Valve Insufficiency, Tricuspid Regurgitation
Brief summary
A prospective, single-arm, multi-center first-in-human (FIH) study to evaluate the safety and performance of the Innoventric Trillium™ Stent Graft System. Twenty (20) patients in 8 investigational sites will be enrolled. All enrolled study patients will be assessed at baseline, during the procedure, at discharge, after 1 month, 3 months, 6 months, 1 year, 1.5 years, 2 years, and 3 years following the index procedure.
Interventions
DEVICETrillium™
Trillium™ Stent Graft for Functional Tricuspid Valve Replacement
Sponsors
Innoventric LTD
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
First In Human study
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Enrolled patients must meet ALL the following criteria: 1. Age \>40 (no upper limit) 2. Patient has clinically significant TR graded as severe based on the presence of systolic hepatic vein flow reversal, and VCW≥7mm or EROA≥40mm\^2 3. Symptomatic despite medical therapy; patient must be on diuretic therapy. 4. Peak central venous pressure of ≥ 15mmHg 5. The local site Heart Team determines that the patient is appropriate for transcatheter tricuspid intervention 6. Patient is willing and able to comply with all specified study evaluations. 7. Patient has NYHA functional classification of III or IV 8. Patient is not eligible for standard-of-care surgical or interventional therapy assessed by the central heart team or has refused standard-of-care surgical and interventional therapy or has received standard-of-care TR therapy and remains symptomatic 9. Patient understands the nature of the study and study requirements and is willing to provide written Informed Consent prior to any study-specific procedures.
Exclusion criteria
Patients will be excluded from participation if ANY of the following criteria apply: 1. Echocardiographic parameters (Any of the following): I. LVEF \< 20% II. Evidence of severe right ventricular dysfunction (e.g. right ventricular TAPSE \< 13.0mm) III. IVC or SVC anatomy that precludes proper device deployment and function 2. Systolic Pulmonary Artery Pressure \> 70mmHg 3. Severe aortic, mitral, and/or pulmonic valve stenosis and/or regurgitation 4. Active endocarditis within 90 days of the scheduled implant 5. Significant pericardial effusion 6. Intra-cardiac masses, thrombi, or vegetation 7. Thrombosis of the venous system 8. Space-consuming lesion in the heart or on the valves, thrombus, or microbial colonization of the valves 9. Untreated clinically significant coronary artery disease requiring immediate revascularization 10. MI or known unstable angina within 30 days prior to the index procedure 11. Any therapeutic invasive cardiac procedure within 30 days prior to the index procedure 12. Any prior cardiac surgery, within 3 months of the index procedure 13. Hemodynamic instability or treated with IV inotropes within 30 days of the index procedure 14. Severe uncontrolled hypertension (SBP ≥ 180 mmHg and/or DBP ≥ 110 mm Hg) 15. Severe uncontrolled hypotension (SBP≤80 mmHg and/or DBP≤40 mmHg) 16. Cerebrovascular Accident (CVA) within the past 90 days 17. Kidney dysfunction with estimated Glomerular Filtration Rate (eGFR) \< 30 ml/min/1.73 m\^2 or patient is on chronic dialysis 18. Significant frailty (i.e. Clinical Frailty Scale© (CFS) ≥ 7) within 90 days of the scheduled implant procedure 19. Chronic liver disease with a MELD score of 20 or greater 20. Chronic anemia (Hb \< 9 g/L) not corrected by transfusion 21. Thrombocytopenia (Platelet count\< 100,000/mm3) or thrombocytosis (Platelet count \> 750,000/mm3) 22. Bleeding disorders or hypercoagulable state 23. Active peptic ulcer or active gastrointestinal (GI) bleeding within 90 days of the scheduled implant 24. Contraindication to anticoagulants or antiplatelet agents 25. Currently or history of IV drug use 26. Pregnant or lactating; or female of childbearing potential with a positive pregnancy test 24 hours before any study-related radiation exposure. 27. Inability to access the femoral vein with a 24 FR guide (e.g., DVT, occluded femoral veins). 28. Known allergy to stainless steel, nickel, titanium, PET or contrast agents that cannot be adequately pre-medicated. 29. Known hypersensitivity or contraindication to procedural medications which cannot be adequately managed medically 30. Impaired judgment 31. Undergoing emergent or urgent treatment for tricuspid insufficiency 32. Currently participating in another investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the endpoints of this study 33. Co-morbid condition(s) that, in the opinion of the Investigator, limit life expectancy to \< 12 months 34. Cardiac cachexia 35. In the judgment of the Investigator, co-morbid condition(s) that could limit the patient's ability to participate in the study, including compliance with follow-up requirements, or that could impact the scientific integrity of the study 36. Patient is under guardianship 37. Presence of any prosthetic device in the SVC or IVC (excluding pace-maker, ICD and CRT leads) 38. Elevated inflammatory markers within 2 weeks of the scheduled procedure (e.g. CRP\>1.5mg/dL).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety Endpoint | Evaluated immediately after intervention, discharge and 30 days | Rate of device or procedure-related MAEs and Freedom from unplanned surgery or re-intervention, due to life-threatening device or procedure failure |
| Technical performance | Evaluated immediately after intervention | Successful access, delivery, and retrieval of the Trillium delivery system, the device is anchored both in SVC and IVC. |
| Efficacy Endpoint | Evaluated immediately after intervention | TR grade as measured on the device valves (Echocardiography), or by hepatic vein systolic backflow (Echocardiography), or reduction in peak central venous pressure (Invasive hemodynamic measurement). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety Endpoint | Assessment at 3-month, 6-month and 1-year | Composite of all device or procedure-related MAEs. |
| Efficacy Endpoint | Assessment at 30 days, 3-month, 6-month and 1-year | One or more of the following- * TR grade measured on the device valves (Echocardiography), or by hepatic vein systolic backflow (Echocardiography), or measured by a regurgitant fraction (CMR) \[at 30 days, 3-month, 6-month, and 1-year\] * Rate of hospitalizations for HF \[at 30 days, 3-month, 6-month, and 1-year\] Or one or more of the following- * Clinical Frailty Scale (CFS) \[at 30 days, 3-month, 6-month, and 1-year\] * HF functional class (NYHA) \[at 30 days, 3-month, 6-month, and 1-year\] * Six-minute walk test (6MWT) \[at 30 days, 3-month, 6-month, and 1-year\] * The Kansas City Cardiomyopathy Questionnaire (KCCQ) \[at 30 days, 3-month, 6-month, and 1-year\] |
Other
| Measure | Time frame | Description |
|---|---|---|
| Other Endpoints | Assessment at 30 days, 3-month, 6-month and 1-year | transthoracic echocardiography (TTE) will be performed to determine acceptable performance of the device defined as a reduction in hepatic vein systolic backflow to moderate (systolic blunting) or better. In addition, the tricuspid valve complex will be imaged to capture the following parameters for comparison to baseline: Page 46 of 118 -Confidential- 1. TR grade (qualitative) 2. Jet area 3. EROA and regurgitant volume 4. RV and LV dimensions 5. RA area/volume 6. LVEF 7. Tricuspid annular plane systolic excursion (TAPSE) 8. IVC dimensions/respiratory variations 9. Pulmonary artery pressure (PAP) 10. Right atrial pressure (RAP) 11. RV pressure 12. IVC/SVC pressure It should be noted that the above-mentioned parameters are primarily being captured for research purposes and may not be affected by the device. The following clinical and laboratory parameters will be captured for comparison to baseline values: 1. Mini Nutrition Assessment (MNA)® 2. Clinical Frailty Scale© |
Countries
Belgium, Germany, Israel, Spain
Outcome results
None listed