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Streamlined One-wire Logistics Optimize Transcatheter Aortic Valve Replacement
Sponsor: Solo Pace, Inc.
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).
Key Details
Gender
All
Age Range
21 Years - 85 Years
Study Type
INTERVENTIONAL
Enrollment
20
Start Date
2025-09
Completion Date
2026-04
Last Updated
2025-08-05
Healthy Volunteers
No
Conditions
Interventions
Aortic valve repair/replacement
TAVR or valvuloplasty using the Fusion System for delivery of the treatment system and for temporary rapid pacing