ENABLE MRI (Magnetic Resonance Imaging)
Completed · Not applicable
Conditions studied: Magnetic Resonance Imaging
In brief
The objective of this study is to collect data to confirm the safety and effectiveness of the Image Ready™ MR (Magnetic Resonance) Conditional Defibrillation System when used in the 1.5T (Tesla) 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. .
Key facts
- Study ID
- NCT02652481
- Run by
- Boston Scientific Corporation
- People needed
- 500
- Starts
- 2016-01-01
- Expected to finish
- 2018-05-04
- Last updated by the study team
- 2021-01-25
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Cardiology Associates of Northeast Arkansas — Jonesboro, Arkansas, United States
- Huntington Memorial Hospital — Pasadena, California, United States
- University of California - San Diego-N — San Diego, California, United States
- John Muir Medical Center — Walnut Creek, California, United States
- Manatee Memorial Hospital — Bradenton, Florida, United States
- Lakeland Regional Medical Center — Lakeland, Florida, United States
- University Community Hospital — Tampa, Florida, United States
- Emory University Hospital — Atlanta, Georgia, United States
- St. John's hospital — Springfield, Illinois, United States
- St. Vincent's Hospital — Indianapolis, Indiana, United States
- University of Iowa Hospitals and Clinics — Iowa City, Iowa, United States
- Marquette General Hospital — Marquette, Michigan, United States
- Centracare Heart and Vascular Center — Saint Cloud, Minnesota, United States
- HealthEast St. Joseph's Hospital — Saint Paul, Minnesota, United States
- North Mississippi Medical Center — Tupelo, Mississippi, United States
- Cox Health — Springfield, Missouri, United States
- Northwell Health — New York, New York, United States
- University of North Carolina Hospital — Chapel Hill, North Carolina, United States
- OhioHealth Research and Innovation Institute - Riverside Methodist Hospital — Columbus, Ohio, United States
- The Toledo Hospital — Toledo, Ohio, United States
- Providence St. Vincent Medical Center — Portland, Oregon, United States
- Bryn Mawr Medical Specialists — Bryn Mawr, Pennsylvania, United States
- Thomas Jefferson University Hospital — Philadelphia, Pennsylvania, United States
- Rapid City Regional Hospital — Rapid City, South Dakota, United States
- Heart Center Research, LLC — Huntsville, Alabama, United States
Full record on ClinicalTrials.gov
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