Early Feasibility of 'Pivot Extend' for Tricuspid Regurgitation Treatment

The Pivot Extend Tricuspid Regurgitation Spacer Device is an investigational implant designed to reduce tricuspid regurgitation (TR) by occupying the regurgitant orifice and improving leaflet coaptation. The device is implanted via a transcatheter procedure under imaging guidance. Following implantation, participants will undergo post-procedural monitoring for at least 24 hours to ensure safety and device stability. The device is intended for long-term placement, with scheduled follow-up assessments at designated intervals over a 12-month period to evaluate its safety and efficacy. Device removal may be performed if adverse events occur or if deemed necessary by the investigator.