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

Not Applicable

Completed

• Conditions: Congenital Heart Defect
• Interventions: Procedure: pressure gradient measurement; Device: MRWire

• Registration Number: NCT02493634
• Lead Sponsor: Nano4Imaging GmbH

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.

Study Timeline

• Study First Submitted: 2015-06-22
• Study First Submitted QC: 2015-07-08
• Study First Posted: 2015-07-09
• Study Start: 2015-08
• Primary Completion: 2017-01-18
• Study Completion: 2017-03-29
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-28
• Last Update Posted: 2018-03-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
pressure gradient measurement	MRWire	Diagnostic procedure to measure pressure gradient in series of patients. Focus is on safety and absence of adverse events
pressure gradient measurement	pressure gradient measurement	Diagnostic procedure to measure pressure gradient in series of patients. Focus is on safety and absence of adverse events

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (3)

Royal Free Hospital- Great Ormond Street Hospital; 🇬🇧 London, United Kingdom

Herzzentrum Leipzig; 🇩🇪 Leipzig, Germany

Deutsches Herzzentrum Munchen; 🇩🇪 Munich, Bavaria, Germany