Evaluation of the Innoventric Trillium™ Stent Graft for treating severe tricuspid regurgitation
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)
This study is testing a new stent graft to see if it can help people with severe tricuspid regurgitation feel better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Innoventric LTD Industry-sponsored |
| Locations | 12 sites (Thousand Oaks, California and 11 other locations) |
| Trial ID | NCT06212193 on ClinicalTrials.gov |
What this trial studies
This study is an early feasibility assessment of the Innoventric Trillium™ Stent Graft aimed at treating patients with severe or greater tricuspid regurgitation. It is a prospective, single-arm, multi-center study involving up to 15 patients across 10 sites in the US and 3 sites in Germany. Participants will undergo assessments at various intervals, including baseline, during the procedure, and at multiple follow-up points over five years to evaluate the safety and performance of the device.
Who should consider this trial
Good fit: Ideal candidates include patients with severe tricuspid regurgitation and significant symptoms who are not eligible for or have refused standard surgical interventions.
Not a fit: Patients with severe right ventricular dysfunction or significant mitral valve issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option for patients suffering from severe tricuspid regurgitation who are not candidates for standard therapies.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in treating other valvular heart diseases, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Thousand Oaks, California and 11 other locations
- Cardiovascular Institute of Los Robles Health System — Thousand Oaks, California, United States (Recruiting)
- Ascension St. John — Detroit, Michigan, United States (Recruiting)
- Mayo Clinic Hospital (Rochester) — Rochester, Minnesota, United States (Recruiting)
- Weill Cornell Medicine — New York, New York, United States (Recruiting)
- Stony Brook Heart Institute — Stony Brook, New York, United States (Recruiting)
- The Christ Hospital — Cincinnati, Ohio, United States (Recruiting)
- Lankenau Heart Institute — Philadelphia, Pennsylvania, United States (Recruiting)
- TriStar Centennial Medical Center — Nashville, Tennessee, United States (Recruiting)
- University of Washington Medical Center — Seattle, Washington, United States (Recruiting)
- University Medicine Mainz — Mainz, Rhineland-Palatinate, Germany (Recruiting)
- Helios Health Institute GmbH, Leipzig — Leipzig, Saxony, Germany (Recruiting)
- German Heart Center at Charité (DHZC) — Berlin, State of Berlin, Germany (Recruiting)
Study contacts
- Study coordinator: Chen Lereya
- Email: chen@innoventric.com
- Phone: +972-52-8981783
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.