Innoventric Trillium™ Stent Graft Early Feasibility Study (EFS)

Launched by INNOVENTRIC LTD · Jan 17, 2024

Keywords

ClinConnect Summary

The Innoventric Trillium™ Stent Graft Early Feasibility Study is a clinical trial designed to test a new treatment for patients with severe tricuspid regurgitation (TR), a condition where the heart's tricuspid valve does not close properly, causing blood to flow backward into the heart. The goal of this study is to evaluate the safety and effectiveness of the Innoventric Trillium™ Stent Graft, a device that may help improve symptoms for those who cannot have standard surgical treatments. The trial is currently recruiting participants aged 65 to 74 who have significant TR, a high central venous pressure, and are experiencing severe symptoms that limit their daily activities.

To be eligible for the study, patients should have been diagnosed with severe TR and cannot undergo traditional surgery or have already received treatment but still feel unwell. However, certain health conditions will exclude patients from participating, such as severe heart dysfunction, significant issues with other heart valves, or severe liver or kidney disease. Participants in the trial will receive close monitoring and care while using this new stent graft, and their progress will be carefully tracked to see how well the treatment works. This trial is an important step in finding better options for people with this challenging heart condition.

Gender

ALL

Eligibility criteria

• 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