The MagnaSafe Registry: Determining the Risks of Magnetic Resonance Imaging (MRI) in the Presence of Pacemakers and Implantable Cardioverter Defibrillators (ICDs)
MagnaSafe
1 other identifier
observational
2,039
1 country
21
Brief Summary
This study will create a registry of patients with pacemakers and implantable ICDs who will undergo clinically indicated MRI and will document the incidence of any adverse events or changes in device parameters that might be associated with the procedure.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2009
Longer than P75 for all trials
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2009
CompletedFirst Submitted
Initial submission to the registry
May 20, 2009
CompletedFirst Posted
Study publicly available on registry
May 22, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2014
CompletedNovember 23, 2015
November 1, 2015
5.2 years
May 20, 2009
November 20, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Rate of device failure.
Anytime during follow up
Secondary Outcomes (1)
Rate of device parameter changes
Anytime during follow up
Interventions
The aim of the present protocol is to prospectively determine the adverse event rate of non-thoracic MRI for patients with implanted cardiac devices by collecting pre- and post-MRI device interrogations in a multi-center registry.
Eligibility Criteria
Adult patient with pacemaker or ICD that is scheduled for a clinically indicated MRI.
You may qualify if:
- Male or female 18 years or older
- Able to provide informed consent
- Permanent implanted pacemaker or ICD
- Strong clinical indication for MRI; in the clinical setting where MRI is the diagnostic modality of choice for a specific disease state without acceptable alternative imaging technology as determined by the ordering physician.
- Patient is scheduled for non-thoracic MRI (joint, extremity, brain, pelvis, cervical, and lumbar or sacral spine)
You may not qualify if:
- Metallic objects that represent a contraindication to MR imaging, including: intra-orbital or intra-ocular retained metal fragments, and intracranial vascular clips and coils
- Claustrophobia unresponsive to pre-procedure sedatives
- Morbid obesity (abdominal diameter \>60 cm)
- ICD or pacemaker generator placement prior to 2002
- ICD and pacing dependent
- Pregnancy
- Device generator battery voltage at elective replacement index (ERI)
- Presence of active implantable medical device (other than pacemaker or ICD)
- Presence of abandoned leads (with the exception of post CABG temporary epicardial pacing wires)
- Presence of implanted cardiac device in the abdominal position
- Pacemaker or ICD that is labeled as MRI-Conditional (approved by the FDA for exposure to MRI).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Scripps Healthlead
- Scripps Cliniccollaborator
- Abbott Medical Devicescollaborator
- Boston Scientific Corporationcollaborator
- Biotronik, Inc.collaborator
Study Sites (21)
Providence St. Joseph Medical Center
Burbank, California, 91505, United States
Scripps Clinic/Green Hospital
La Jolla, California, 92037, United States
Scripps Memorial Hospital
La Jolla, California, 92037, United States
UCLA Cardiac Arrhythmia Center
Los Angeles, California, 90095, United States
Spectrum Clinical Research
Moreno Valley, California, 92553, United States
University of California, San Diego
San Diego, California, 92103, United States
Yale University School of Medicine
New Haven, Connecticut, 06520, United States
Aventura Hospital and Medical Center
Aventura, Florida, 33180, United States
Northern Indiana Research Alliance
Fort Wayne, Indiana, 46804, United States
Baptist Health Lexington
Lexington, Kentucky, 40503, United States
Providence Heart Institute
Southfield, Michigan, 48075, United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216, United States
The Valley Hospital
Ridgewood, New Jersey, 07450, United States
Advanced Cardiovascular Imaging
New York, New York, 10128, United States
Oklahoma Heart Research and Education Foundation
Tulsa, Oklahoma, 74133, United States
Abington Health System
Abington, Pennsylvania, 19001, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212, United States
The Methodist Hospital
Houston, Texas, 77030, United States
Intermountain Medical Center
Murray, Utah, 84157, United States
Aurora St. Luke's Medical Center
Milwaukee, Wisconsin, 53215, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Related Publications (2)
Russo RJ, Costa HS, Silva PD, Anderson JL, Arshad A, Biederman RW, Boyle NG, Frabizzio JV, Birgersdotter-Green U, Higgins SL, Lampert R, Machado CE, Martin ET, Rivard AL, Rubenstein JC, Schaerf RH, Schwartz JD, Shah DJ, Tomassoni GF, Tominaga GT, Tonkin AE, Uretsky S, Wolff SD. Assessing the Risks Associated with MRI in Patients with a Pacemaker or Defibrillator. N Engl J Med. 2017 Feb 23;376(8):755-764. doi: 10.1056/NEJMoa1603265.
PMID: 28225684DERIVEDWiesenfeld HC. Screening for Chlamydia trachomatis Infections in Women. N Engl J Med. 2017 Feb 23;376(8):765-773. doi: 10.1056/NEJMcp1412935. No abstract available.
PMID: 28225683DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Robert J Russo, MD, PhD
Scripps Clinic
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 20, 2009
First Posted
May 22, 2009
Study Start
April 1, 2009
Primary Completion
June 1, 2014
Study Completion
June 1, 2014
Last Updated
November 23, 2015
Record last verified: 2015-11