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

Congenital Heart Defect Clinical Trial

— MRWIREPMCF  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02493634
• Other study ID #: N4IPMCF2015
• Status: Completed
• Phase: N/A
• First received: June 22, 2015
• Last updated: March 28, 2018
• Start date: August 2015
• Est. completion date: March 29, 2017

Study information

• Verified date: March 2018
• Source: Nano4Imaging GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: March 29, 2017
• Est. primary completion date: January 18, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Congenital Heart Defect
• Heart Defects, Congenital

Intervention

Procedure:
• pressure 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.

Device:
• MRWire

Locations

Country	Name	City	State
Germany	Herzzentrum Leipzig	Leipzig
Germany	Deutsches Herzzentrum Munchen	Munich	Bavaria
United Kingdom	Royal Free Hospital- Great Ormond Street Hospital	London

Sponsors (2)

Lead Sponsor	Collaborator
Nano4Imaging GmbH	CERES GmbH

Countries where clinical trial is conducted

Germany,  United Kingdom, 

References & Publications (3)

Kos S, Huegli R, Hofmann E, Quick HH, Kuehl H, Aker S, Kaiser GM, Borm PJ, Jacob AL, Bilecen D. Feasibility of real-time magnetic resonance-guided angioplasty and stenting of renal arteries in vitro and in Swine, using a new polyetheretherketone-based magnetic resonance-compatible guidewire. Invest Radiol. 2009 Apr;44(4):234-41. doi: 10.1097/RLI.0b013e31819b00f1. — View Citation

Kos S, Huegli R, Hofmann E, Quick HH, Kuehl H, Aker S, Kaiser GM, Borm PJ, Jacob AL, Bilecen D. First magnetic resonance imaging-guided aortic stenting and cava filter placement using a polyetheretherketone-based magnetic resonance imaging-compatible guidewire in swine: proof of concept. Cardiovasc Intervent Radiol. 2009 May;32(3):514-21. doi: 10.1007/s00270-008-9483-5. Epub 2008 Dec 30. — View Citation

Kos S, Huegli R, Hofmann E, Quick HH, Kuehl H, Aker S, Kaiser GM, Borm PJ, Jacob AL, Bilecen D. MR-compatible polyetheretherketone-based guide wire assisting MR-guided stenting of iliac and supraaortic arteries in swine: feasibility study. Minim Invasive Ther Allied Technol. 2009;18(3):181-8. doi: 10.1080/13645700902921971. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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