Innoventric Trillium™ Stent Graft Early Feasibility Study (EFS)
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)
1 other identifier
interventional
15
2 countries
12
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Aug 2024
Longer than P75 for not_applicable
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 20, 2023
CompletedFirst Posted
Study publicly available on registry
January 18, 2024
CompletedStudy Start
First participant enrolled
August 5, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2030
ExpectedMarch 7, 2025
November 1, 2024
12 months
December 20, 2023
March 5, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
at the end of the procedure, at discharge - typically within a week, and 30 days
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 \[at discharge, and 30 days\]
at the end of the procedure, at discharge - typically within a week, and 30 days
Secondary Outcomes (2)
Rate of Major Adverse Events [Safety endpoint]
at 3 months, 6 months, 1, 2, 3, 4, and 5 years
Efficacy endpoint
at 30 days, 3-month, 6-month, 1-year, 2-year, 3-year, 4-year, and 5-year
Other Outcomes (1)
Observational endpoint
at 30 days, 3 months, 6 months, 1, 2, 3, 4, and 5 years
Study Arms (1)
Innoventric Trillium™ Stent Graft
EXPERIMENTALTranscatheter cross-caval tricuspid valve replacement with the Innoventric Trillium™ Stent Graft
Interventions
Trillium™ Stent Graft for Cross-Caval Tricuspid Valve Replacement
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Innoventric LTDlead
- Innoventric Inc.collaborator
Study Sites (12)
Cardiovascular Institute of Los Robles Health System
Thousand Oaks, California, 91360, United States
Ascension St. John
Detroit, Michigan, 48236, United States
Mayo Clinic Hospital (Rochester)
Rochester, Minnesota, 55902, United States
Weill Cornell Medicine
New York, New York, 10065, United States
Stony Brook Heart Institute
Stony Brook, New York, 11794, United States
The Christ Hospital
Cincinnati, Ohio, 45219, United States
Lankenau Heart Institute
Philadelphia, Pennsylvania, 19096, United States
TriStar Centennial Medical Center
Nashville, Tennessee, 37203, United States
University of Washington Medical Center
Seattle, Washington, 98195, United States
University Medicine Mainz
Mainz, Rhineland-Palatinate, 55131, Germany
Helios Health Institute GmbH, Leipzig
Leipzig, Saxony, 04103, Germany
German Heart Center at Charité (DHZC)
Berlin, State of Berlin, 13353, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 20, 2023
First Posted
January 18, 2024
Study Start
August 5, 2024
Primary Completion
August 1, 2025
Study Completion (Estimated)
August 1, 2030
Last Updated
March 7, 2025
Record last verified: 2024-11