Last updated on November 2016

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


Brief description of study

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

Detailed Study Description

This clinical investigation is a prospective, multicenter, 2-phase, single arm, Asian study. - In the 1st phase patients will be enrolled within 60 days of implant with a St. Jude Medical™ MR Conditional ICD System approved for thoracic scan with 1.5 Tesla MRI scanning machines. - In the 2nd phase patients will be enrolled within 60 days of implant with a St. Jude Medical™ MR Conditional ICD System approved* for thoracic scan with 3.0 Tesla MRI scanning machines. - NOTE: The 2nd phase of this study will start only after receiving appropriate regulatory approval for MRI labelling at 3.0T and phase 1 enrollment has completed

Clinical Study Identifier: NCT02877693

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Kler Tarlochan

Escorts Heart Institute and Research Centre
New Delhi, India
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