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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02493634

Acronym

MRWIREPMCF

Enrollment

Registered

2015-07-09

Start date

2015-08-31

Completion date

2017-03-29

Last updated

2018-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Congenital Heart Defect

Keywords

Magnetic Resonance spectroscopy, Aortic Arch

Brief 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.

Interventions

PROCEDUREpressure 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.

DEVICEMRWire

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

* patients with clinical indication for cardiac magnetic resonance and conventional diagnostic catheterisation * patients with body weight of \> 40 kg in which the introduction of an introducer of \> 5 French is possible. * subject provided written informed consent using the approved consent form or in case of a minor the subject provided written assent and its legal guardian provided written informed consent.

Exclusion criteria

* major surgery in the last 42 days * history of irreversible bleeding disorder * contraindication to cardiac magnetic resonance * Contraindications to guidewire procedures, such as evidence of active infection * women of child-bearing potential who cannot provide a negative pregnancy test * chronic total occlusion.

Design outcomes

Primary

Measure	Time frame	Description
Procedural success	Up to 30 days after procedure	procedural success means that insertion, steerability and visibility of the guide wire in the MR guided intervention was successfully reached, in the absence of adverse events up to 30 days after procedure

Countries

Germany, United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026