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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Congenital Heart Defect

Intervention / Treatment
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* Procedure: pressure gradient measurement
* Device: MRWire


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: pressure gradient measurement<br>Diagnostic procedure to measure pressure gradient in series of patients. Focus is on safety and absence of adverse events | Procedure: pressure gradient measurement<br>* 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.<br>* Other names: MRWire;Device: MRWire<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedural success | 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 | Up to 30 days after procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Magnetic Resonance spectroscopy, Aortic Arch