This record was last updated August 5, 2025 (before its estimated March 2026 completion). Its status may not reflect the trial's current state.
Summary
The goal of this study is to determine the safety and performance of a new guidewire and pacing system called the Fusion System in treating patients undergoing transcatheter aortic valve replacement (TAVR) or similar procedures. The main questions it aims to answer are:
Is the Fusion System safe? Is the Fusion System's clinical performance acceptable?
Participants will asked to sign a study consent and report any adverse events experienced until they are discharged from hospital (or a maximum of 2 days following their procedure).
Protocol Amendment History
1 amendment
This ClinicalTrials.gov record has been amended once since 2025-07-21.