Early Feasibility Study (EFS) of the 'Pivot Extend' in Treatment for Tricuspid Regurgitation (SPACER Study)
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.
• Adults 18 years of age or older at the time of screening
• Those with symptoms despite medical therapy (OMT, diuretics/medications) for TR for at least 1 month at screening
• Those who meet the criteria of severe (3+) or worse on the TR grade classification table on echocardiography performed at the screening visit
• Those with clinical symptoms of New York Heart Association (NYHA) class 2 or worse
• Those deemed suitable for percutaneous valve intervention by a Heart Team that includes at least one cardiologist, one cardiac surgeon and one anesthesiologist.
• Those who have voluntarily decided to participate in this clinical trial and have provided written informed consent
• Those who can understand and follow the investigator's instructions and are able to participate for the entire duration of the study