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ProMRI AFFIRM Study of the EVIA/ENTOVIS Pacemaker With Safio S Pacemaker Leads

NCT01460992 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 121

Last updated 2013-11-28

No results posted yet for this study

Summary

This investigation is designed to demonstrate the clinical safety of the EVIA/ ENTOVIS pacemaker system when used under specific MRI conditions.

Conditions

  • Cardiac Disease

Interventions

PROCEDURE

Evia/Entovis pacemaker system under Magnetic Resonance Imaging (MRI) conditions

patients will undergo an MRI scan for 30 minutes.

Sponsors & Collaborators

  • Biotronik SE & Co. KG

    lead INDUSTRY

Principal Investigators

  • Aldo Rinaldi, Dr. · Cardiology Department, St Thomas' Hospital Lambeth Palace Road London, SE1 7EH United Kingdom E-mail: [email protected]

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-03-31
Primary Completion
2013-10-31
Completion
2013-11-30

Countries

  • Austria
  • Czechia
  • Germany
  • Switzerland
  • United Kingdom

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 NCT01460992 on ClinicalTrials.gov