| NCT ID | NCT04905017 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Trisol Medical |
| Condition | Tricuspid Regurgitation |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2022-03-02 |
| Primary Completion | 2026-01-01 |
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 30 participants in total. It began in 2022-03-02 with a primary completion date of 2026-01-01.
⚠ 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
The objective of this early feasibility study is to gain early clinical insight into Trisol system safety and performance to treat patients with moderate or greater tricuspid regurgitation (TR).
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.
Contact & Investigator
Isaac George, MD
PRINCIPAL INVESTIGATOR
Columbia University
Frequently Asked Questions
Who can join the NCT04905017 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, 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 NCT04905017 currently recruiting?
Yes, NCT04905017 is actively recruiting participants. Contact the research team at rond@trisol-medical.com for enrollment information.
Where is the NCT04905017 trial being conducted?
This trial is being conducted at Los Angeles, United States, Atlanta, United States, New York, United States, Cleveland, United States and 3 additional locations.
Who is sponsoring the NCT04905017 clinical trial?
NCT04905017 is sponsored by Trisol Medical. The principal investigator is Isaac George, MD at Columbia University. The trial plans to enroll 30 participants.