NCT01258218

Accent MRI Pacemaker and Tendril MRI Lead New Technology Assessment

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 78 (actual)
• Sponsor: Abbott Medical Devices · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The intent of this study is to evaluate the performance of the implanted Accent MRI TM system in a clinical setting and optionally in the MRI environment. This system includes the St. Jude Medical Tendril MRI™ lead and SJM Accent MRITM DR pacemaker. Also the MRI Activator™ will be evaluated in this study. The MRI Activator is a handheld device that allows the user to enable and disable MRI Settings as well as check the status of MRI Settings in the pacemaker. The patient population under study includes patients with a standard bradycardia pacing indication.

Conditions

• Bradycardia

Interventions

Type	Name	Description
DEVICE	Implantation of an Accent MRI device	Implantation of an Accent MRI device

Timeline

• Start date: 2011-02-01
• Primary completion: 2011-11-01
• Completion: 2011-11-01
• First posted: 2010-12-10
• Last updated: 2019-02-04

Locations

1 site across 1 country: Austria