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A Post-market Clinical Evaluation of St. Jude Medical™ MR Conditional ICD System on Patients Undergoing Magnetic Resonance Imaging

NCT02877693 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 205

Last updated 2023-12-08

Study results available
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Summary

To assess the clinical performance of the St. Jude Medical™ MR Conditional ICD System in patients undergoing an elective thoracic MRI scan.

Conditions

  • ICD
  • Tachycardia

Interventions

RADIATION

Thoracic MRI Scan

The ICD system will be exposed to MRI scan of thoracic region, where the radiofrequency (RF) component of the scan is maximized.

Sponsors & Collaborators

  • Abbott Medical Devices

    lead INDUSTRY

Principal Investigators

  • Grant Kim · St. Jude Medical, Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-10-10
Primary Completion
2020-03-23
Completion
2020-03-23

Countries

  • India
  • Malaysia
  • South Korea

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 NCT02877693 on ClinicalTrials.gov