Status:

COMPLETED

St. Mary's Duluth Clinic (SMDC) Pacemaker Magnetic Resonance Imaging (MRI) Study

Lead Sponsor:

Essentia Health

Conditions:

Cardiovascular Disease

Eligibility:

All Genders

18+ years

Brief Summary

The purpose of this study is to monitor and follow non-pacemaker dependent patients with implanted permanent pacemakers, who undergo medically required Magnetic Resonance Imaging (MRI) scans. Patient...

Eligibility Criteria

Inclusion

  • Permanent pacemaker or ICD implanted for at least 6 weeks
  • Referred for medically indicated MRI
  • Age greater or equal to 18 years old

Exclusion

  • ICD market released before 2001 including GDT Ventak-AV, GDT MINI-II, GDT MINI-IV, GDT MINI-III, GDT Prizm-2 MDT GEM-I series
  • Epicardial coronary sinus lead or subcutaneous array
  • Unable to program all leads to bipolar configuration
  • Pacemaker Dependent
  • Device has reached elective replacement or end of life
  • Other usual contraindications to MRI scanning
  • The use of inotropic pharmacological agents, such as dobutamine, during the MRI

Key Trial Info

Start Date :

January 1 2005

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

July 1 2011

Estimated Enrollment :

150 Patients enrolled

Trial Details

Trial ID

NCT00631904

Start Date

January 1 2005

End Date

July 1 2011

Last Update

September 2 2011

Active Locations (1)

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Essentia Health

Duluth, Minnesota, United States, 55805