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

Cardiac Disease Clinical Trial

Official title:
Master Study for the MRI Compatibility of the EVIA/ENTOVIS Pacemaker in Combination With Safio S Pacemaker Lead

Clinical Trial Summary

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

Clinical Trial Description

In the past, MR scans were always contraindicated for pacemaker patients. If particular prerequisites and conditions are fulfilled, MR scans can now be conducted on patients with BIOTRONIK's EVIA/ENTOVIS pacemakers in combination with the Safio S pacemaker leads, scheduled to be part of this clinical study.

The specific MRI conditions for this investigation with the EVIA/ENTOVIS pacemaker family and Safio S pacemaker leads are defined in the study protocol ;

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01460992
Study type Observational
Source Biotronik SE & Co. KG
Contact
Status Completed
Phase N/A
Start date March 2012
Completion date November 2013
View Details
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