HVP_ENABLE MRI

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

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:

1. Subject will receive or is implanted with an ICD or CRT-D pulse generator in the left or right pectoral region
2. Subject is able and willing to undergo an MR scan without intravenous sedation
3. Subject is willing and capable of providing informed consent and participating in all testing/ visits associated with this clinical study
4. Subject is age 18 or above, or of legal age to give informed consent specific to state and national law


See clinicaltrials.gov for full details.
IDE
NCT02652481
Heart and Vascular, All Other
Electrophysiology
Scott Brancato, , M.D.
Boston Scientific
Ellen Muir
  • Providence Portland Medical Center
  • Providence St. Vincent Medical Center