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A Clinical Evaluation of the Durata or Optisure High Voltage Leads and Ellipse VR ICD Undergoing MRI, an IDE Study — MRI Ready IDE  

Implantable Defibrillator User Clinical Trial

Official title:
A Clinical Evaluation of the Durata or Optisure High Voltage Leads and Ellipse VR ICD Undergoing Magnetic Resonance Imaging, an Investigational Device Exemption (IDE) Study

Clinical Trial Summary

To demonstrate safety and efficacy of the Durata or Optisure high voltage lead and Ellipse VR ICD in an MRI environment.

Clinical Trial Description

The intent of this IDE study is to evaluate the safety and efficacy of the Durata or Optisure lead and Ellipse VR ICD that have undergone an MRI scan. The patient population under study includes patients indicated for or who have been implanted with a Durata or Optisure lead and an Ellipse VR ICD. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02787291
Study type Interventional
Source Abbott Medical Devices
Contact
Status Completed
Phase N/A
Start date May 2016
Completion date April 11, 2018
View Details
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