RecruitingNot ApplicableNCT06212193
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)
Sponsor
Innoventric LTD
Enrollment
15 participants
Start Date
Aug 5, 2024
Study Type
INTERVENTIONAL
Conditions
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).
Eligibility
Min Age: 18 YearsMax Age: 85 Years
Inclusion Criteria4
- 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 Criteria11
- 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
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
DEVICETrillium™
Trillium™ Stent Graft for Cross-Caval Tricuspid Valve Replacement
Locations(12)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06212193
Related Trials
TriClip Japan Post-Approval Study
NCT075096581 location
Edwards PASCAL Transcatheter Valve Repair System Pivotal Clinical Trial
NCT0409714579 locations
Clinical Safety and Efficacy of the VDyne Transcatheter Tricuspid Valve Replacement System for the Treatment of Tricuspid Regurgitation ( VISTA-US)
NCT0584828411 locations
Berlin Registry of Right Heart Interventions
NCT045701631 location
Evaluation of the Impact of Interventional Treatments for Symptomatic, Severe Tricuspid Valve Insufficiency on Renal Integrity and Function, as Well as on Physical Function and Activity in Older Adults.
NCT074641061 location