Early Feasibility of 'Pivot Extend' for Tricuspid Regurgitation Treatment

Launched by TAU-MEDICAL CO., LTD. · Mar 10, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new device called "Pivot Extend" to help treat patients with a heart condition known as tricuspid regurgitation (TR). TR occurs when the heart's tricuspid valve doesn’t close properly, leading to symptoms like shortness of breath or swelling in the legs. The goal of the trial is to see if this device is safe to use over a long period and if it can improve the symptoms of severe TR in patients who haven’t found relief with standard medications.

To participate, individuals must be at least 18 years old and have had symptoms of TR despite taking medications for at least a month. They should also have a diagnosis of severe TR based on an ultrasound of the heart. Patients will be monitored throughout the study to check the safety and effectiveness of the device. Before joining, participants will need to undergo tests to ensure they are suitable for the procedure. It’s important to know that there are certain health conditions that may exclude someone from participating, so potential participants should discuss their specific situation with their doctor.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Adults 18 years of age or older at the time of screening
• • 2. Those with symptoms despite medical therapy (OMT, diuretics/medications) for TR for at least 1 month at screening
• • 3. Those who meet the criteria of severe (3+) or worse on the TR grade classification table on echocardiography performed at the screening visit
• • 4. Those with clinical symptoms of New York Heart Association (NYHA) class 2 or worse
• • 5. Those deemed suitable for percutaneous valve intervention by a Heart Team that includes at least one cardiologist, one cardiac surgeon and one anesthesiologist.
• • 6. Those who have voluntarily decided to participate in this clinical trial and have provided written informed consent
• • 7. Those who can understand and follow the investigator's instructions and are able to participate for the entire duration of the study
• Exclusion Criteria:
• • 1. Those with blood clots, emboli, masses, or growths in the vascular system of the heart or lungs on an echocardiogram and cardiac CT scan performed at the screening visit
• • 2. Those with uncorrected blood clotting disorders based on hemanalysis performed at the screening visit
• • 3. Those who are unable to use anticoagulant agents (NOAC ex.Xarelto)
• • 4. Those who have had major bleeding (not including minor bleeding, such as a nosebleed that can be hemostasized) treated with anticoagulants prior to participation in this clinical trial
• • 5. Those with severe anemia (hemoglobin ≦10g/dL) that requires hospitalization
• • 6. Those who have an implanted device such as an implantable cardioverter defibrillator (ICD) or pacemaker prior to participation in this clinical trial
• • 7. Those whose anatomy, in the opinion of the investigator, is not suitable for implantation of an investigational medical device based on echocardiogram and cardiac CT scan performed at the screening visit
• • 8. Those who require surgery or interventional procedures (coronary artery bypass graft (CABG) or surgery for atrial septal defect (ASD)) based on an echocardiogram performed at the screening visit
• • 9. Those with a platelet count of 80,000/uL or less based on hemanalysis performed at the screening visit
• • 10. Patients with pulmonary arterial hypertension with a TR Vmax greater than 3.5 m/s on echocardiography performed at the screening visit or a pulmonary vascular resistance of more than 3 Wood Units on right heart catheterization
• • 11. Those with a left ventricular ejection fraction (LVEF) of less than 50% on echocardiogram performed at the screening visit
• • 12. Those who have had active gastrointestinal bleeding or a digestive procedure within 3 months prior to participation in this study (those with the potential for gastrointestinal bleeding)
• • 13. Those with a history of cerebrovascular accident (CVA) or transient ischemic attacks (TIA) within 30 days prior to participation in this clinical trial
• • 14. Those with a history of myocardial infarction (MI) within 30 days prior to participation in this study
• • 15. Those with active endocarditis requiring antibiotic treatment
• • 16. Those with malignancies with end-stage renal failure requiring hemodialysis and other chronic conditions who have a life expectancy of less than one year
• • 17. Those with moderate or severe aortic, pulmonary artery, or mitral stenosis on echocardiogram performed at the screening visit
• • 18. Those with moderate or worse mitral valve regurgitation or severe aortic valve regurgitation on the echocardiogram performed at the screening visit
• • 19. Those with calcification of the tricuspid valve lobes affecting the procedure on an echocardiogram performed at the screening visit
• • 20. Those who have participated in another clinical trial within 30 days prior to participation in this clinical trial
• • 21. Pregnant or nursing women, or women planning to become pregnant during the clinical trial period
• • 22. Women of childbearing potential who are not using a medically accepted birth control method
• • 23. Those with a coexisting condition, which most likely limits the participant´s life expectancy to less than one year.
• • 24. Those with a preexisting pulmonary valve prosthesis or RV to PA conduit.
• • 25. Those with clinical findings other than the above that, in the opinion of the investigator, are medically inappropriate for this clinical trial