Evaluating the Trisol system for treating tricuspid regurgitation

Early Feasibility Study of the Trisol System

This study is testing a new device called the Trisol system to see if it can safely help people with moderate to severe tricuspid regurgitation feel better.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Trisol Medical (Industry-sponsored)
• Locations: 7 sites (Los Angeles, California and 6 other locations)
• Trial ID: NCT04905017 on ClinicalTrials.gov

What this trial studies

This early feasibility study aims to assess the safety and performance of the Trisol system in patients with moderate or greater tricuspid regurgitation. It is a prospective, single-arm, open-label, multi-center clinical study that will involve transcatheter tricuspid valve replacement procedures. Participants will be evaluated based on their echocardiographic assessments and functional classifications to determine eligibility. The study seeks to provide early clinical insights into this innovative treatment approach.

Who should consider this trial

Good fit: Ideal candidates include adults over 18 with symptomatic moderate or greater tricuspid regurgitation who are at high surgical risk.

Not a fit: Patients with mild tricuspid regurgitation or those who are not at high surgical risk may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could offer a new minimally invasive treatment option for patients suffering from significant tricuspid regurgitation.

How similar studies have performed: Other studies have shown promise with transcatheter approaches for heart valve interventions, suggesting potential for success in this novel application.

Eligibility criteria

Inclusion Criteria:

1. Age \>18 years.
2. Subject meets the legal minimum age to provide informed consent based on local regulatory requirements.
3. Participant has symptomatic, moderate or greater functional or degenerative tricuspid regurgitation (TR) as determined by the Echocardiography Core Lab assessment of a qualifying transthoracic echocardiogram (TTE) and/or transesophageal echocardiogram (TEE).
4. New York Heart Association (NYHA) Functional Class II to IVa.
5. Participant is deemed at high surgical risk or greater for tricuspid valve surgery and appropriate for transcatheter tricuspid valve replacement as determined by the local Heart Team.
6. Participant adequately treated based upon medical standards, including for coronary artery disease, mitral regurgitation, and Guideline-Directed Medical Therapy (GDMT) for heart failure for at least 30-days prior to index procedure.
7. Male or non-pregnant female.
8. Participant understands the nature of the procedure and provides written informed consent prior to any study specific assessments.
9. Participant is willing and able to comply with the specified study requirements and follow-up evaluations.
10. Participant is anatomically suitable for the Trisol system, including trans-jugular access as per imaging requirements, and is approved by the Subject Screening Committee

Exclusion Criteria:

1. Previous tricuspid valve repair or replacement which may impede proper study device delivery or deployment.
2. Stroke or transient ischemic event within the previous 90 days.
3. Acute myocardial infarction within the previous 90 days.
4. Hemodynamic instability requiring inotropic therapy or mechanical hemodynamic support devices.
5. Untreated clinically significant coronary artery disease requiring revascularization.
6. Implant or revision of any rhythm management device (CRT or CRT-D) or implantable cardioverter-defibrillator within the previous 30 days.
7. New or untreated right heart chamber or/and superior vena cava intracardiac mass, thrombus, or vegetation.
8. Systolic pulmonary arterial pressure (sPAP) \> 80 mmHg as measured by pulmonary pressure catheter.
9. Severe RV dysfunction with RV Stroke Work Index (RVSWI) g/m2/beat \<400 and Pulmonary Artery Pulsatile index (PAPi) \<2.
10. Ongoing sepsis, including active endocarditis.
11. Active infection requiring current antibiotic therapy.
12. Known bleeding diathesis or hypercoagulable state.
13. Blood dyscrasias as defined: leukopenia (WBC \<3000 cells/mm3), thrombocytopenia (platelet count \<50,000 cells/mm3).
14. Active gastrointestinal (GI) bleeding or history of GI bleed within the previous 60 days that would preclude anticoagulation.
15. LVEF \<25% as measured by resting echocardiogram within 30 days prior to index procedure.
16. Patients in whom transesophageal echocardiography is contraindicated.
17. Aortic, mitral or pulmonary valve disease (severe stenosis or severe regurgitation) requiring intervention or performed within 90 days prior to enrollment.
18. Severe tricuspid valve stenosis.
19. Need for any percutaneous cardiovascular intervention, cardiovascular surgery, or carotid surgery within 30 days prior to index procedure.
20. Need for emergent or urgent non cardiac surgery for any reason.
21. Contraindication or known allergy to device components, anticoagulation therapy with a vitamin K antagonist, or to contrast media that cannot be adequately premedicated.
22. History of cardiac transplantation, or participant currently listed for urgent transplant (e.g., UNOS Status 1).
23. Presence of any known life-threatening non-cardiac disease that will limit the subject's life expectancy to less than one year.
24. Contraindication or known hypersensitivity to anticoagulant therapy and/or antiplatelet therapy.
25. Venous anatomy unsuitable for implant delivery.
26. Pacemaker or ICD lead present that would prevent appropriate valve placement.
27. Active COVID-19 infection.
28. Comorbid condition(s) that, in the opinion of the investigator, could limit the patient's ability to participate in the study, including compliance with follow-up requirements, or that could impact the scientific integrity of the study.
29. Previously enrolled in this study or currently participating in another investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the endpoints of this study.

Where this trial is running

Los Angeles, California and 6 other locations

• Cedars-Sinai Medical Center — Los Angeles, California, United States (Recruiting)
• Piedmont Heart Institute — Atlanta, Georgia, United States (Recruiting)
• Columbia University Medical Center/NYPH — New York, New York, United States (Recruiting)
• Cleveland Clinic — Cleveland, Ohio, United States (Recruiting)
• Main Line Health / Lankenau Institute for Medical Research — Wynnewood, Pennsylvania, United States (Not_yet_recruiting)
• Vanderbilt University Medical Center — Nashville, Tennessee, United States (Recruiting)
• University of Virginia Cardiology — Charlottesville, Virginia, United States (Recruiting)

Study contacts

• Principal investigator: Isaac George, MD — Columbia University
• Study coordinator: Ron Davidson, B. Sc., MBA

Conditions Tricuspid Regurgitation