NCT07090811

Streamlined One-wire Logistics Optimize Transcatheter Aortic Valve Replacement

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Solo Pace, Inc. · Industry
• Sex: All
• Age: 21 Years – 85 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Aortic Valve Disease

Interventions

Type	Name	Description
DEVICE	Aortic valve repair/replacement	TAVR or valvuloplasty using the Fusion System for delivery of the treatment system and for temporary rapid pacing

Timeline

• Start date: 2025-09-01
• Primary completion: 2026-03-01
• Completion: 2026-04-01
• First posted: 2025-07-29
• Last updated: 2025-08-05

Regulatory

• FDA-regulated device study