Congenital Heart Defect Clinical Trial
Official title:
Post-market Clinical Follow-up Study With Magnetic Resonance Imaging Conditional Guide Wire
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.
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.
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