Clinical Trial: Early Phase Study Using the 'Pivot Extend' System as a Treatment for Patients With Tricuspid Regurgitation

U.S., Sept. 16 -- ClinicalTrials.gov registry received information related to the study (NCT07172477) titled 'Early Phase Study Using the 'Pivot Extend' System as a Treatment for Patients With Tricuspid Regurgitation' on Aug. 19.

Brief Summary: 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 ...