NCT02493634

Post-market Clinical Follow-up Study With Magnetic Resonance Imaging Conditional Guide Wire

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Nano4Imaging GmbH · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

This is post-market clinical follow-up study on 25 consecutive patients in two centers to evaluate the safety and performance of magnetic resonance imaging conditional guide wire and the acceptability of identified risks in the clinical evaluation and to detect emerging risks on the basis of factorial evidence.The procedure will be done in patients with a clinical indication for cardiac magnetic resonance and conventional catheterisation.

Detailed description

This is post-market clinical follow-up study on 25 consecutive patients in two centers to evaluate the safety of a guide wire conditional for use in magnetic resonance imaging and the acceptability of identified risks in the clinical evaluation and to detect emerging risks on the basis of factorial evidence. The guidewire is used to access the patients central circulatory system and in particular for the introduction and exact placement of a pressure catheter to measure the pressure gradient over the aortic arch. The procedure will be done in patients with a clinical indication for cardiac magnetic resonance and conventional catheterisation.Patients need to have a body weight over 40 kg and the introduction of a 5 French catheter should be possible. The primary endpoint is the measurement of procedural success, defined as successful insertion, steerability and visibility in MRI, in the absence of device related adverse events such as damage to vessel wall. In addition structural integrity of the instruments is to be assessed.

Conditions

• Congenital Heart Defect

Interventions

Type	Name	Description
PROCEDURE	pressure gradient measurement	A guidewire is used to introduce and position a pressure catheter under magnetic resonance guidance to conduct flow and pressure measurement in the aortic arch to evaluate vascular resistance.
DEVICE	MRWire

Timeline

• Start date: 2015-08-01
• Primary completion: 2017-01-18
• Completion: 2017-03-29
• First posted: 2015-07-09
• Last updated: 2018-03-30

Locations

3 sites across 2 countries: Germany, United Kingdom