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

Nano4Imaging

Status: Completed

Conditions: Congenital Heart Defect

Treatments: Device: MRWire; Procedure: pressure gradient measurement

Study type: Interventional

Funder types: Industry

Identifiers

NCT02493634

N4IPMCF2015

Details and patient eligibility

About

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.

Full 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.

Enrollment: 25 patients

Sex: All

Volunteers: No 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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

pressure gradient measurement

Other group

Description:

Diagnostic procedure to measure pressure gradient in series of patients. Focus is on safety and absence of adverse events

Treatment:

Procedure: pressure gradient measurement

Device: MRWire