Streamlined One-wire Logistics Optimize Transcatheter Aortic Valve Replacement

ConditionAortic Valve Disease

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age21-85

SponsorSolo Pace, Inc.

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Scheduled for a THV or BAV procedure in accordance with standard institutional protocols requiring temporary pacing.

Willing and able to comply with the follow-up evaluations

Been informed of the nature of the study, agrees to its provisions, and has provided written informed consent approved by the appropriate Institutional Review Board (IRB) or Ethics Committee (EC)

Disqualifiers

Undergoing an emergent procedure

An ST elevation myocardial infarction (STEMI) within 7 days of procedure

Had cardiac arrest within 7 days of procedure requiring CPR or defibrillation

An indication to require mechanical cardiac support (MCS) post-procedure

Trial design

Design model

Single group

Treatments tested in this trial

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

Treatment groups

20 Participants

are divided into 1 treatment group

Group A: Fusion SystemExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

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

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Solo Pace, Inc.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: