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Early Feasibility of 'Pivot Extend' for Tricuspid Regurgitation Treatment

Tau-MEDICAL Co., Ltd. · 2025
ClinicalTrials.gov · Datasets · License: Public Domain · 2025
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This clinical trial aims to evaluate the safety and demonstrate the efficacy of treatment to improve tricuspid regurgitation (TR) symptoms in patients with severe and clinically symptomatic TR through long-term implantation of an investigational medical device. 1. Determine the safety of long-term implantation of the investigational medical device "Pivot Extend" by monitoring for MACEs associated with the investigational medical device or procedure that may occur with long-term associated with the investigational medical device or procedure that may occur with long-term implantation. 2. Device success, procedural success, and clinical outcomes of long-term implantation of the investigational medical device "Pivot Extend" will be monitored.
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