Early Feasibility Study (EFS) of the 'Pivot Extend' for the Treatment of Tricuspid Regurgitation, Including High-Risk Patients (SPACER Study, Australia)
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
• Deemed suitable for percutaneous valve intervention by a Heart Team that includes at least one cardiologist and one cardiac surgeon
• Is able to understand and follow the investigator's instructions and is able to participate for the entire duration of the study