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NOT YET RECRUITING
NCT07090811
NA

Streamlined One-wire Logistics Optimize Transcatheter Aortic Valve Replacement

Sponsor: Solo Pace, Inc.

View on ClinicalTrials.gov

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

Interventions

DEVICE

Aortic valve repair/replacement

TAVR or valvuloplasty using the Fusion System for delivery of the treatment system and for temporary rapid pacing