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Clinical Study to Confirm MRI Safety and Effectiveness Using St. Jude Medical (SJM) Cardiac Rhythm Management Systems

NCT03012568 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 119

Last updated 2019-08-05

No results posted yet for this study

Summary

This is a clinical investigational plan (CIP) for the "Clinical Study to Confirm MRI Safety and Effectiveness Using SJM Cardiac Rhythm Management Systems (ASSURE MRI)". This study intends to enroll patients who meet standard bradycardia or tachycardia indications and have already been implanted with one of the SJM device/lead combinations listed in this protocol. The objective of this study is to confirm the safety and effectiveness of each of the four SJM device/lead combinations in an MRI environment. This clinical investigation is sponsored by St. Jude Medical.

Conditions

  • Bradycardia
  • Tachycardia

Interventions

DEVICE

SJM Implantable cardiac devices

SJM implantable devices undergoing MRI scan

Sponsors & Collaborators

  • Abbott Medical Devices

    lead INDUSTRY

Principal Investigators

  • Grant Kim · Abbott Medical Devices

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-11-10
Primary Completion
2018-01-26
Completion
2018-03-29

Countries

  • Australia
  • India

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 NCT03012568 on ClinicalTrials.gov