Innoventric Trillium™ Stent Graft Early Feasibility Study (EFS)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorInnoventric LTD
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Trillium™
DeviceTrillium™ Stent Graft for Cross-Caval Tricuspid Valve Replacement
Treatment groups
15 Participants
are divided into 1 treatment groupGroup A: Innoventric Trillium™ Stent GraftExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Rate of Major Adverse Events [Safety endpoint]
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
Time frame
at the end of the procedure, at discharge - typically within a week, and 30 days2
Technical Performance
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 \[at discharge, and 30 days\]
Time frame
at the end of the procedure, at discharge - typically within a week, and 30 daysSecondary outcomes
1
Rate of Major Adverse Events [Safety endpoint]
* 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 \[at 6 months\]
Time frame
at 3 months, 6 months, 1, 2, 3, 4, and 5 years2
Efficacy endpoint
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 \[at 30 days, 3-month, 6-month, 1-year, 2-year, 3-year, 4-year, and 5-year\]
Time frame
at 30 days, 3-month, 6-month, 1-year, 2-year, 3-year, 4-year, and 5-yearOther outcomes
1
Observational endpoint
All-cause mortality
Time frame
at 30 days, 3 months, 6 months, 1, 2, 3, 4, and 5 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Innoventric LTD
Lead sponsor
Innoventric Inc.
Collaborator
Source ClinicalTrials.gov