Participants with severe tricuspid regurgitation may require heart surgery to repair or replace the tricuspid valve. However, there is a high risk associated with these surgeries and it is often not feasible for elderly patients or those with other medical conditions.
The goal of this clinical investigation is
* To assess the safety of the investigational device "Pivot Extend" in participants aged 18 years or over with severe and clinically symptomatic Tricuspid Regurgitation (TR) deemed suitable for percutaneous valve intervention * To evaluate device success, procedural success and clinical outcomes in improving TR symptoms following implantation of the "Pivot Extend" device
Has voluntarily decided to participate in this clinical trial and has provided written informed consent
Adults aged 18 years or older at the time of informed consent
Has symptoms of TR corresponding to at least NYHA Class II, despite receiving optimal medical therapy for at least 30 days prior to screening
Meets the criteria at least severe (3+) on the TR grade classification table on echocardiography performed at the screening visit
Has 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
Uncorrected blood clotting disorders based on hematology tests performed at the screening visit
Unable to use anticoagulant agents (NOAC ex.Xarelto)
A history of major bleeding (excluding minor bleeding such as nosebleed that can be hemostasized) treated with anticoagulants at any time prior to participation in this clinical trial
Tau Medical Australia Pty Ltd
Lead sponsor
Tau-MEDICAL Co., Ltd.
Collaborator