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Streamlined One-wire Logistics Optimize Transcatheter Aortic Valve Replacement

NCT07090811 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-08-05

No results posted yet for this study

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

DEVICE

Aortic valve repair/replacement

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

Sponsors & Collaborators

  • Solo Pace, Inc.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-30
Primary Completion
2026-03-31
Completion
2026-04-30
FDA Device
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07090811 on ClinicalTrials.gov