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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
TAVR or valvuloplasty using the Fusion System for delivery of the treatment system and for temporary rapid pacing
Transcatheter heart valve device migration/embolization or inability to complete BAV procedure.
Incidence of failure of the Solo Pace Fusion System to provide adequate pacing leading to transcatheter heart valve device migration/embolization or the inability to complete the BAV procedure
Time frame: Intraprocedure
Successful deployment of THV or BAV system over the Fusion Guidewire
The Primary Performance Endpoint for the study consists of the following criteria (note: both criteria must be met): * Successful delivery to the intended position and successful deployment of a commercially available THV or BAV delivery system over the Fusion Guidewire * Successful pacing during THV or BAV deployment in unipolar configuration using the Fusion System
Time frame: Intraprocedure
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