Clinical trial NCT02493634: Post-market Clinical Follow-up Study With Magnetic Resonance Imaging Conditional Guide Wire
Official title: Post-market Clinical Follow-up Study With Magnetic Resonance Imaging Conditional Guide Wire
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Congenital Heart Defect
Keywords: Magnetic Resonance spectroscopy
Aortic Arch
Lead sponsor: Nano4Imaging GmbH
Sponsor class: INDUSTRY
Collaborators: name: CERES GmbH
First posted: 2015-07-09
Enrollment: 25
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Procedural success
timeFrame: Up to 30 days after procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Deutsches Herzzentrum Munchen
state: Bavaria
city: Leipzig
country: Germany
facility: Herzzentrum Leipzig
city: London
country: United Kingdom
facility: Royal Free Hospital- Great Ormond Street Hospital
Study officials:
affiliation: German Heart Center
name: Peter Ewert, Prof, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
citation: 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.