NCT01460992

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 121 (actual)
• Sponsor: Biotronik SE & Co. KG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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

Conditions

• Cardiac Disease

Interventions

Type	Name	Description
PROCEDURE	Evia/Entovis pacemaker system under Magnetic Resonance Imaging (MRI) conditions	patients will undergo an MRI scan for 30 minutes.

Timeline

• Start date: 2012-03-01
• Primary completion: 2013-10-01
• Completion: 2013-11-01
• First posted: 2011-10-27
• Last updated: 2013-11-28

Locations

9 sites across 5 countries: Austria, Czechia, Germany, Switzerland, United Kingdom