Transcatheter Treatment of Tricuspid Valve Regurgitation

Launched by TRIFLO CARDIOVASCULAR, INC. · Oct 16, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment option for people with a condition called severe tricuspid regurgitation (TR), which happens when the tricuspid valve in the heart doesn’t close properly, causing blood to flow backward. The trial is testing the TriFlo TFO System, a device designed to help fix this problem by supporting the valve while keeping its natural movement intact. This treatment could be especially helpful for patients who have symptoms from TR and may be at high risk for traditional surgery.

To participate in this trial, individuals must be at least 18 years old and have been diagnosed with severe TR. They should also be able to return for follow-up visits after the procedure. However, there are certain conditions that might exclude someone from participating, such as having had recent heart surgery, specific heart conditions, or other serious health issues. Those who join the trial can expect close monitoring throughout the process to ensure their safety and to evaluate how well the treatment works. It's important to note that the trial is not yet recruiting participants, so interested individuals will need to wait for it to start.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age 18 years or older
• • 2. Symptomatic severe tricuspid regurgitation 3+ on a scale of 0+ to 5+, according to semi-quantitative echocardiographic color flow doppler evaluation
• • 3. Tricuspid valve (TV) morphology which fulfills anatomic criteria of eligibility for the device according to Imaging Core Lab assessment
• • 4. Signed (by subject or legal representative) and dated approved subject informed consent form prior to any study related procedure
• • 5. Available and able to return to the study site for post-procedural follow-up examination
• Exclusion Criteria:
• • CARDIOVASCULAR EXCLUSION CRITERIA
• • 1. Requirement for an interventional percutaneous procedure or cardiac surgical procedure \<30 days before or after index procedure
• • 2. Prior tricuspid repair or replacement, implantation of an artificial heart valve.
• • 3. Active endocarditis or history of endocarditis within the previous 12 months.
• • 4. Left Ventricular Ejection Fraction \<30%
• • 5. Severe aortic and mitral stenosis and/or regurgitation
• • 6. Severe tricuspid valve stenosis
• • 7. Severe right ventricular failure
• • 8. Systolic Pulmonary Artery pressure \>70 mmHg
• • 9. Echocardiographic evidence of intracardiac mass, thrombus, tumor, myxoma or vegetation
• • 10. Femoral vein, inferior vena cava or evidence of intracardiac thrombus not adequately treated
• • 11. Presence of an occluded or thrombosed inferior vena cava (IVC) filter that would interfere with the delivery catheter, or ipsilateral deep vein thrombosis is present.
• • 12. Trans-tricuspid Pacemaker leads implanted within 90 days before the index procedure.
• • EXCLUSION DUE TO COMORBIDITIES
• • 13. Cerebrovascular event within the previous 6 months.
• • 14. Myocardial infarction within 30 days prior to enrollment.
• • 15. Bleeding disorders or hypercoagulable state, thrombocytopenia (platelet count \<100,000/mm3), thrombocytosis (\>750,000/mm3) or patient who refuses blood transfusions.
• • 16. Acute anemia Hb\<8 g/dl not adequately treated or white blood cell count\<1000.
• • 17. Severe renal failure requiring chronic dialysis or eGFR\<25.
• • 18. Severe Liver disfunction - class C cirrhosis.
• • 19. Severe CLD with oxygen dependent COPD.
• • 20. Coronary artery disease requiring revascularization
• • EXCLUSION DUE TO CONTRAINDICATIONS
• • 21. Unable to undergo transesophageal echocardiogram (TEE) and cardiac computed tomography (CT) or screening TEE is unsuccessful.
• • 22. Contraindication, hypersensitivity or known allergy to device's components (nickel or titanium), aspirin, anti-coagulation and antiplatelet therapy or contrast media that cannot be adequately pre-medicated.
• • 23. Known intolerance to anti-coagulation treatments.
• • GENERAL EXCLUSION CRITERIA
• • 24. Female patient pregnant (urine HCG test result positive) or lactating.
• • 25. Known alcohol or drug abuser.
• • 26. Currently participating in the study of an investigational drug or device.
• • 27. Neoplasia with Life expectancy \< 12 months