Status:
RECRUITING
Innoventric Trillium™ Stent Graft Early Feasibility Study (EFS)
Lead Sponsor:
Innoventric LTD
Collaborating Sponsors:
Innoventric Inc.
Conditions:
Tricuspid Regurgitation
Tricuspid Regurgitation Functional
Eligibility:
All Genders
18-85 years
Phase:
NA
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 regur...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 5 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2030
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT06212193
Start Date
August 5 2024
End Date
August 1 2030
Last Update
March 7 2025
Active Locations (12)
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1
Cardiovascular Institute of Los Robles Health System
Thousand Oaks, California, United States, 91360
2
Ascension St. John
Detroit, Michigan, United States, 48236
3
Mayo Clinic Hospital (Rochester)
Rochester, Minnesota, United States, 55902
4
Weill Cornell Medicine
New York, New York, United States, 10065