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New treatment option for Tricuspid Regurgitation
Official title Innoventric Trillium™ Stent Graft Early Feasibility Study (EFS)
ClinicalTrials.gov ID: NCT06212193
What this study is testing
- What it's testing
- 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).
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 85
You may be able to join if
- 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 treatment therapy or has refused standard-of-care surgical and treatment therapy or has...
You likely can't join if
- 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
See the full eligibility 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 treatment therapy or has refused standard-of-care surgical and treatment therapy or has received standard-of-care TR therapy and remains symptomatic
- 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\ 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
The study team makes the final eligibility decision.
Where it's taking place
- Thousand Oaks, California, United States
- Detroit, Michigan, United States
- Rochester, Minnesota, United States
- New York, New York, United States
- Stony Brook, New York, United States
- Cincinnati, Ohio, United States
- Philadelphia, Pennsylvania, United States
- Nashville, Tennessee, United States
- Seattle, Washington, United States
- Mainz, Rhineland-Palatinate, Germany
- Leipzig, Saxony, Germany
- Berlin, State of Berlin, Germany
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Thousand Oaks, California, United States; Detroit, Michigan, United States; Rochester, Minnesota, United States; New York, New York, United States; Stony Brook, New York, United States; Cincinnati, Ohio, United States and 6 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.