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ProMRI Study of the Entovis Pacemaker System (Phase B)

NCT02009696 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 221

Last updated 2015-11-25

Study results available
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Summary

The objective of the ProMRI Study (Phase B) is to demonstrate the clinical safety of the ProMRI Pacemaker System when used under specific MRI conditions without scan exclusion zone.

Conditions

  • Magnetic Resonance Imaging (MRI); Cardiac Pacing

Interventions

DEVICE

Patients with a ProMRI Pacemaker System

Bradycardia Slow Heart Beat

OTHER

Magnetic Resonance Imaging (MRI) scan

MRI scan of heart/chest or thoracic spine.

Sponsors & Collaborators

  • Biotronik, Inc.

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-12-31
Primary Completion
2014-11-30
Completion
2015-01-31

Countries

  • United States

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 NCT02009696 on ClinicalTrials.gov