NCT02493634

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2015

Geographic Reach
2 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 22, 2015

Completed
17 days until next milestone

First Posted

Study publicly available on registry

July 9, 2015

Completed
23 days until next milestone

Study Start

First participant enrolled

August 1, 2015

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 18, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 29, 2017

Completed
Last Updated

March 30, 2018

Status Verified

March 1, 2018

Enrollment Period

1.5 years

First QC Date

June 22, 2015

Last Update Submit

March 28, 2018

Conditions

Congenital Heart Defect

Keywords

Magnetic Resonance spectroscopyAortic Arch

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

pressure gradient measurement

OTHER

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

Procedure: pressure gradient measurementDevice: MRWire

Interventions

pressure gradient measurementPROCEDURE

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.

Also known as: MRWire
pressure gradient measurement
MRWireDEVICE
pressure gradient measurement

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Deutsches Herzzentrum Munchen

Munich, Bavaria, 80636, Germany

Location

Herzzentrum Leipzig

Leipzig, 04289, Germany

Location

Royal Free Hospital- Great Ormond Street Hospital

London, WC1N 1EH, United Kingdom

Location

Related Publications (3)

  • 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.

    PMID: 19115070BACKGROUND

  • 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.

    PMID: 19431070BACKGROUND

  • 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.

    PMID: 19252440BACKGROUND

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Peter Ewert, Prof, MD

    German Heart Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 22, 2015

First Posted

July 9, 2015

Study Start

August 1, 2015

Primary Completion

January 18, 2017

Study Completion

March 29, 2017

Last Updated

March 30, 2018

Record last verified: 2018-03

Locations

GB(1)DE(2)