Innoventric Trillium™ Stent Graft Early Feasibility Study (EFS)

Not Applicable

Recruiting

• Conditions: Tricuspid Regurgitation Functional; Tricuspid Regurgitation

• 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.

Study Timeline

• Study First Submitted: 2023-12-20
• Study First Submitted QC: 2024-01-17
• Study First Posted: 2024-01-18
• Study Start: 2024-08-05
• Status Verified: 2024-11
• Last Update Submitted: 2025-03-05
• Last Update Posted: 2025-03-07
• Primary Completion: 2025-08
• Study Completion: 2030-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

• 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 Criteria

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

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 failure
Technical 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 \[at 30 days, 3-month, 6-month, 1-year, 2-year, 3-year, 4-year, and 5-year\]

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

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