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Accent MRI Pacemaker and Tendril MRI Lead New Technology Assessment

NCT01258218 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 78

Last updated 2019-02-04

No results posted yet for this study

Summary

The intent of this study is to evaluate the performance of the implanted Accent MRI TM system in a clinical setting and optionally in the MRI environment. This system includes the St. Jude Medical Tendril MRI™ lead and SJM Accent MRITM DR pacemaker. Also the MRI Activator™ will be evaluated in this study. The MRI Activator is a handheld device that allows the user to enable and disable MRI Settings as well as check the status of MRI Settings in the pacemaker. The patient population under study includes patients with a standard bradycardia pacing indication.

Conditions

  • Bradycardia

Interventions

DEVICE

Implantation of an Accent MRI device

Implantation of an Accent MRI device

Sponsors & Collaborators

  • Abbott Medical Devices

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-02-28
Primary Completion
2011-11-30
Completion
2011-11-30

Countries

  • Austria

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 NCT01258218 on ClinicalTrials.gov