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

NCT02787291 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 227

Last updated 2020-09-03

Study results available
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Summary

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

Conditions

  • Implantable Defibrillator User

Interventions

DEVICE

Ellipse VR ICD and Durata/Optisure lead

Non-diagnostic MRI Scan sequence of head and chest

Sponsors & Collaborators

  • Abbott Medical Devices

    lead INDUSTRY

Principal Investigators

  • Saman Nazarian, MD · Johns Hopkins University Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-05-31
Primary Completion
2017-01-12
Completion
2018-04-11

Countries

  • United States
  • Hungary
  • Poland
  • Spain
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02787291 on ClinicalTrials.gov