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ProMRI Study of the Iforia ICD System (Phase C)

NCT02096692 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 154

Last updated 2016-02-29

Study results available
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Summary

The objective of the ProMRI Study is to demonstrate the clinical safety of the ProMRI ICD System when used under specific MRI conditions.

Conditions

  • Implantable Cardioverter-Defibrillator With Magnetic Resonance Imaging

Interventions

DEVICE

Patients with a ProMRI ICD System

Tachycardia Fast 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
2014-06-30
Primary Completion
2015-03-31
Completion
2015-06-30

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 NCT02096692 on ClinicalTrials.gov