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NCT ID: NCT02652481 Active, not recruiting - Clinical trials for Magnetic Resonance Imaging

Expanding MRI Access for Patients With New and Existing ICDs and CRT-Ds ( ENABLE MRI)

Start date: January 2016
Phase: N/A
Study type: Interventional

The objective of this study is to collect data to confirm the safety and effectiveness of the ImageReady™ MR Conditional Defibrillation System when used in the 1.5T MRI environment under the labeled Conditions of Use (Phase I). Additionally, the study will assess medically necessary MR scans according to the labeled Conditions of Use to provide real-world scanning data (Phase I and Phase II). The study also aims to demonstrate the continued ability of the ImageReady MR Conditional Defibrillation System to sense and detect ventricular fibrillation (VF) post MRI scan by collecting and analyzing data from spontaneous VF episodes, "for-cause" VF inductions, and from an optional VF induction Sub-study.