Innoventric Trillium™ Stent Graft Early Feasibility Study (EFS)
- Conditions
- Tricuspid Regurgitation FunctionalTricuspid Regurgitation
- Interventions
- Device: Trillium™
- Registration Number
- NCT06212193
- Lead Sponsor
- Innoventric LTD
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 15
- 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
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Innoventric Trillium™ Stent Graft Trillium™ Transcatheter cross-caval tricuspid valve replacement with the Innoventric Trillium™ Stent Graft
- Primary Outcome Measures
Name Time Method 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 failureTechnical 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 Outcome Measures
Name Time Method 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 \[at 30 days, 3-month, 6-month, 1-year, 2-year, 3-year, 4-year, and 5-year\]
Related Research Topics
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Trial Locations
- Locations (12)
Cardiovascular Institute of Los Robles Health System
🇺🇸Thousand Oaks, California, United States
Ascension St. John
🇺🇸Detroit, Michigan, United States
Mayo Clinic Hospital (Rochester)
🇺🇸Rochester, Minnesota, United States
Weill Cornell Medicine
🇺🇸New York, New York, United States
Stony Brook Heart Institute
🇺🇸Stony Brook, New York, United States
The Christ Hospital
🇺🇸Cincinnati, Ohio, United States
Lankenau Heart Institute
🇺🇸Philadelphia, Pennsylvania, United States
TriStar Centennial Medical Center
🇺🇸Nashville, Tennessee, United States
University of Washington Medical Center
🇺🇸Seattle, Washington, United States
University Medicine Mainz
🇩🇪Mainz, Rhineland-Palatinate, Germany
German Heart Center at Charité (DHZC)
🇩🇪Berlin, Germany
Helios Health Institute GmbH, Leipzig
🇩🇪Leipzig, Saxony, Germany