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ProMRI PROVEN Master Study

NCT01809665 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 174

Last updated 2016-03-02

No results posted yet for this study

Summary

This investigation is designed to provide supporting evidence for the clinical safety of the Ilesto/Iforia ICD (implantable cardioverter-defibrillator)system and the Evia/Entovis HF-T (Heart Failure) triple chamber pacemaker system when used under specific MRI (magnetic resonance imaging) conditions.

Conditions

  • Safety of MR (Magnetic Resonance) Conditional CRT-pacemakers and ICDs

Interventions

DEVICE

ICD/CRT-P therapy

OTHER

MRI

Sponsors & Collaborators

  • Biotronik SE & Co. KG

    lead INDUSTRY

Principal Investigators

  • Wolfgang R. Bauer, Prof.Dr.Dr. · Universitätsklinikum Würzburg, Medizinische Klinik und Poliklinik I, Oberdürrbacher Str. 6, 97080 Würzburg, Germany

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-06-30
Primary Completion
2015-05-31
Completion
2015-09-30

Countries

  • Australia
  • Austria
  • Canada
  • Czechia
  • France
  • Germany
  • Hungary
  • Switzerland

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 NCT01809665 on ClinicalTrials.gov