NCT06212193 Innoventric Trillium™ Stent Graft Early Feasibility Study (EFS)
| NCT ID | NCT06212193 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Innoventric LTD |
| Condition | Tricuspid Regurgitation |
| Study Type | INTERVENTIONAL |
| Enrollment | 15 participants |
| Start Date | 2024-08-05 |
| Primary Completion | 2025-08 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 15 participants in total. It began in 2024-08-05 with a primary completion date of 2025-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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).
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06212193 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 85 Years, studying Tricuspid Regurgitation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06212193 currently recruiting?
Yes, NCT06212193 is actively recruiting participants. Contact the research team at chen@innoventric.com for enrollment information.
Where is the NCT06212193 trial being conducted?
This trial is being conducted at Thousand Oaks, United States, Detroit, United States, Rochester, United States, New York, United States and 8 additional locations.
Who is sponsoring the NCT06212193 clinical trial?
NCT06212193 is sponsored by Innoventric LTD. The trial plans to enroll 15 participants.