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Cardiac MRI After Pacemaker Replacement

NCT02195024 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2021-01-12

No results posted yet for this study

Summary

Aim of this trial is to investigate feasibility of cardiac magnetic resonance imaging (cMRI) in patients with long term implanted coradial leads upgraded to an MRI conditional pacemaker system, to assess MR-image quality and to prove the safety of MRI in this specific population in the short term as well as during long term follow-up.

Conditions

  • Bradycardia
  • Cardiac Pacemaker
  • Magnetic Resonance Imaging

Interventions

PROCEDURE

cardiac MRI group

• All subjects of the MRI group will undergo a predefined series of magnetic resonance heart scans ≥ six (6) weeks after device exchange

Sponsors & Collaborators

  • Boston Scientific Corporation

    collaborator INDUSTRY

  • Dr. Dirk Bastian

    lead OTHER

Principal Investigators

  • Dirk Bastian, MD · Paracelsus Medical University Nürnberg

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-07-31
Primary Completion
2017-05-31
Completion
2017-05-31

Countries

  • Germany

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 NCT02195024 on ClinicalTrials.gov