Tricuspid Regurgitation, Tricuspid Regurgitation Functional
Conditions
Keywords
Tricuspid valve, Transcatheter, Tricuspid Regurgitation, Tricuspid valve insufficiency
Brief summary
Early Feasibility Study to evaluate the safety and performance of the Innoventric Trillium™ Stent Graft in the treatment of severe or greater tricuspid regurgitation (TR).
Detailed description
Prospective, single arm, multi-center, Early Feasibility Study (EFS) to assess the safety and performance of the Innoventric Trillium™ Stent Graft in the treatment of severe or greater tricuspid regurgitation (TR). Up to fifteen (15) patients at up to 10 US investigational sites and 3 German investigational sites will be enrolled. All enrolled study patients will be assessed at baseline, during the procedure, at discharge, and after 1 month, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, and 5 years following the index procedure.
Interventions
DEVICETrillium™
Trillium™ Stent Graft for Cross-Caval Tricuspid Valve Replacement
Sponsors
Innoventric Inc.
Innoventric LTD
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Patient has clinically significant TR graded as severe or greater * Peak central venous pressure of ≥ 15mmHg * Patient has NYHA functional classification of III or IV * Patient is not eligible for standard-of-care surgical or interventional therapy or has refused standard-of-care surgical and interventional therapy or has received standard-of-care TR therapy and remains symptomatic
Exclusion criteria
Patients will be excluded from participation if ANY of the following criteria apply: * Severe RV dysfunction defined by TAPSE, RVEF, or RVFAC. * Anatomical suitability according to CT scan. * Systolic Pulmonary Artery Pressure \> 65mmHg * Moderate or more mitral valve stenosis * Greater than moderate mitral valve regurgitation or aortic valve stenosis/regurgitation * Moderate mitral valve regurgitation combined with moderate aortic valve stenosis/regurgitation * Kidney dysfunction with estimated Glomerular Filtration Rate (eGFR) \< 35 ml/min/1.73 m2 within 60 days prior to the index procedure or patient is on chronic dialysis * Liver cirrhosis or moderate or severe liver disease (Child-Turcotte-Pugh class B or C, or a score of 7 or higher) * Thrombocytopenia (Platelet count\< 80,000/mm3) or thrombocytosis (Platelet count \> 750,000/mm3) within 14 days of the index procedure * In the opinion of the Investigator or the study eligibility committee, the patient's life expectancy \< 12 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Major Adverse Events [Safety endpoint] | at the end of the procedure, at discharge - typically within a week, and 30 days | Rate of device or procedure-related Major Adverse Events (MAEs) And Rate of unplanned surgery or re-intervention due to a life-threatening device or procedure failure |
| Technical Performance | at the end of the procedure, at discharge - typically within a week, and 30 days | Successful access, delivery, and retrieval of the Trillium™ delivery system, device is anchored both in SVC and IVC \[at the end of the procedure\] And No need for re-intervention due to device valve regurgitation or para-stent leak \[at discharge, and 30 days\] |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Major Adverse Events [Safety endpoint] | at 3 months, 6 months, 1, 2, 3, 4, and 5 years | * Composite of all device or procedure-related MAEs \[at 3 months, 6 months, 1, 2, 3, 4, and 5 years\]. * Device thrombosis, evaluated by Echocardiography \[at 30 days, 6 months, 1, 2, and 4 years\]. * Device Migration as evaluated by Echocardiography or CMR \[at 6 months\] |
| Efficacy endpoint | at 30 days, 3-month, 6-month, 1-year, 2-year, 3-year, 4-year, and 5-year | One or more of the following- * TR grade as measured on the device valves by Echocardiography, or reduction in peak CVP as measured by right heart catheterization \[at the end of the procedure\] * TR grade as measured on the device valves by Echocardiography \[at 30 days, 6-month, 1-year, 2-year, and 4-year\] * Rate of hospitalizations for HF \[at 6-month, and 1-year\] * HF functional class (NYHA) \[at 30 days, 3-month, 6-month,1-year, 2-year, 3-year, 4-year, and 5-year\] * Six-minute walk test (6MWT) \[at 30 days, 6-month, 1-year, 2-year, and 4-year\] * The Kansas City Cardiomyopathy Questionnaire (KCCQ) \[at 30 days, 3-month, 6-month, 1-year, 2-year, 3-year, 4-year, and 5-year\] * Patient Global Assessment (PGA) for Tricuspid Regurgitation Valve Treatment \[at 30 days, 3-month, 6-month, 1-year, 2-year, 3-year, 4-year, and 5-year\] |
Other
| Measure | Time frame | Description |
|---|---|---|
| Observational endpoint | at 30 days, 3 months, 6 months, 1, 2, 3, 4, and 5 years | All-cause mortality |
Countries
Germany, United States
Contacts
Primary ContactChen Lereya
Backup ContactAmir Danino
Outcome results
None listed