NCT02787291

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 227 (actual)
• Sponsor: Abbott Medical Devices · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Implantable Defibrillator User

Interventions

Type	Name	Description
DEVICE	Ellipse VR ICD and Durata/Optisure lead	Non-diagnostic MRI Scan sequence of head and chest

Timeline

• Start date: 2016-05-01
• Primary completion: 2017-01-12
• Completion: 2018-04-11
• First posted: 2016-06-01
• Last updated: 2020-09-03
• Results posted: 2020-09-03

Locations

32 sites across 5 countries: United States, Hungary, Poland, Spain, United Kingdom