CRC_91049740

ENABLE MRI - ImageReady MR Conditional Defibrillation System Study

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

Key Inclusion Criteria:
Subject will receive or is implanted with an ICD or CRT-D pulse generator in the left or right pectoral region

Subject is able and willing to undergo an MR scan without intravenous sedation

Subject is willing and capable of providing informed consent and participating in all testing/ visits associated with this clinical study

Subject is age 18 or above, or of legal age to give informed consent specific to state and national law
IDE
NCT02652481
Heart and Vascular
Electrophysiology
Maheer Gandhavadi, MD
Boston Scientific
  • Everett Clinic