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

NCT02493634 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2018-03-30

No results posted yet for this study

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.

Conditions

  • Congenital Heart Defect

Interventions

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

Sponsors & Collaborators

  • CERES GmbH

    collaborator INDUSTRY

  • Nano4Imaging GmbH

    lead INDUSTRY

Principal Investigators

  • Peter Ewert, Prof, MD · German Heart Center

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-08-31
Primary Completion
2017-01-18
Completion
2017-03-29

Countries

  • Germany
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02493634 on ClinicalTrials.gov