Safety and Efficacy of Pivot-Bridge for Severe Functional Tricuspid Regurgitation: The First-in-Human Experiences

Summary

Fifteen patients with severe functional TR were treated under fluoroscopy and TTE guidance. Procedural success was achieved in all patients, TR was reduced by at least one grade in every patient, and no serious adverse events occurred during implantation.

Part of the research behind the Pivot‑TR platform for tricuspid regurgitation.

Key results

Study at a glance

Design

Multicenter, single-arm, short-term implantation study

Sites

11 hospitals in Korea

Patients

15 enrolled of 19 screened

Implant duration

Up to 7 days (temporary)

Imaging

Echocardiography and cardiac CT with core-lab review

Results from a single-arm study of 15 patients with temporary implantation; there was no control group. Pivot Bridge is an investigational device, and its safety and effectiveness have not been established.