Confirmatory Clinical Trial of the Evera MRI System for Conditionally-safe MRI Access
NCT ID: NCT02117414
Last Updated: 2016-11-28
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
NA
275 participants
INTERVENTIONAL
2014-04-30
2015-09-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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MRI Group
Subjects randomized to the MRI group will undergo a series of MRI scans at the MRI visit (9-12 weeks post-implant).
MRI scan sequences of the head and chest regions
Non-diagnostic MRI scans
Control Group
Subjects randomized to the Control group will wait for 1 hour without having a series of MRI scans at the waiting period visit (9-12 weeks post-implant).
Waiting Period Visit
Waiting period time will equate to 1 hour
Interventions
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MRI scan sequences of the head and chest regions
Non-diagnostic MRI scans
Waiting Period Visit
Waiting period time will equate to 1 hour
Eligibility Criteria
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Inclusion Criteria
* Subjects who are able to undergo a pectoral implant.
* Subjects who are receiving an ICD for the first time.
* Subjects who are able and willing to undergo elective MRI scanning without sedation.
* Subjects who are geographically stable and available for follow-up at the study site for the length of the study.
* Subjects who are at least 18 years of age (or older, if required by local law).
Exclusion Criteria
* Subjects for whom a single dose of 1.0mg dexamethasone sodium phosphate and/or dexamethasone acetate may be contraindicated.
* Subjects who require a legally authorized representative to obtain informed consent.
* Subjects undergoing device upgrades, change-outs, lead extractions, and/or lead or device revisions.
* Subjects with abandoned or capped leads.
* Subjects who require an indicated MRI scan, other than those specifically described in the Evera MRI™ study, before the one-month post-MRI/waiting period follow-up (approximately 4 months post-implant).
* Subjects with a non-MRI compatible device (such as neurostimulators) or material implant (e.g., non-MRI compatible sternal wires, neurostimulators, biostimulators, metals or alloys).
* Subjects with medical conditions that preclude the testing required by the study protocol or limit study participation.
* Subjects who are enrolled or intend to participate in another clinical trial (of an investigational drug or device, new indication for an approved drug or device, or requirement of additional testing beyond standard clinical practice) during the Evera MRI™ study. Co-enrollment in concurrent trials is only allowed when documented pre-approval is obtained from the Medtronic study manager.
* Female patient who is pregnant, or of childbearing potential and not on a reliable form of birth control. Women of childbearing potential are required to have a negative pregnancy test within seven (7) days prior to device implant.
18 Years
ALL
No
Sponsors
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Medtronic Cardiac Rhythm and Heart Failure
INDUSTRY
Responsible Party
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Principal Investigators
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Michael R Gold, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Medical University of South Carolina
Emanuel Kanal, MD, FACR
Role: PRINCIPAL_INVESTIGATOR
University of Pittsburgh Medical Center, USA
Juerg Schwitter, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital Lausanne (CHUV), Switzerland
Torsten Sommer, MD
Role: PRINCIPAL_INVESTIGATOR
German Red Cross Hospital (DRK) Neuwied, Germany
Locations
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Central Coast Cardiology
Salinas, California, United States
Stanford Hospitals & Clinics
Stanford, California, United States
Hartford Hospital
Hartford, Connecticut, United States
Orlando Health
Orlando, Florida, United States
Prairie Education & Research Cooperative (Springfield IL)
Springfield, Illinois, United States
Iowa Heart
West Des Moines, Iowa, United States
Washington Hospital Center
Washington DC, Maryland, United States
DLP Upper Michigan Cardiovascular Associates PC
Marquette, Michigan, United States
Park Nicollet Methodist Hospital
Saint Louis Park, Minnesota, United States
United Heart and Vascular Clinic
Saint Paul, Minnesota, United States
Mid America Heart Institute (MAHI)
Kansas City, Missouri, United States
HealthCare Partners CCNV
Henderson, Nevada, United States
Cooper University Hospital
Camden, New Jersey, United States
Morristown Memorial Hospital
Morristown, New Jersey, United States
NYU Langone Medical Center
New York, New York, United States
University of North Carolina (UNC) Memorial Hospital
Chapel Hill, North Carolina, United States
Carolinas Medical Center
Charlotte, North Carolina, United States
Cleveland Clinic
Cleveland, Ohio, United States
OhioHealth Research Institute
Columbus, Ohio, United States
Oklahoma Heart Institute
Tulsa, Oklahoma, United States
Lancaster General Hospital
Lancaster, Pennsylvania, United States
University of Pittsburgh Medical Center UPMC Presbyterian
Pittsburgh, Pennsylvania, United States
Medical University of South Carolina (MUSC)
Charleston, South Carolina, United States
Sentara Norfolk General Hospital
Norfolk, Virginia, United States
Aurora St. Luke's Medical Center
Milwaukee, Wisconsin, United States
Centre Hospitalier Régional de la Citadelle
Liège, , Belgium
University of Calgary
Calgary, Alberta, Canada
Queen Elizabeth II Health Sciences Centre
Halifax, Nova Scotia, Canada
Institut Universitaire de Cardiologie et de Pneumologie de Québec (IUCPQ)
Québec, Quebec, Canada
Hospital Clínico Pontificia Universidad Católica
Santiago, , Chile
Universitätsklinikum Bonn
Bonn, , Germany
Praxisklinik Herz und Gefässe
Dresden, , Germany
Medizinische Hochschule Hannover
Hanover, , Germany
Universitätsklinikum Jena - Friedrich Schiller Universität
Jena, , Germany
Queen Mary Hospital
Hong Kong, , Hong Kong
Semmelweis Egyetem AOK
Budapest, , Hungary
Medanta-The Medicity
Gurgaon, , India
Azienda Ospedaliera SS Annunziata
Taranto, , Italy
HagaZiekenhuis - Locatie Leyweg
The Hague, , Netherlands
Prince Sultan Cardiac Center
Riyadh, , Saudi Arabia
Akademiska Sjukhuset
Uppsala, , Sweden
Centre Hospitalier Universitaire Vaudois
Lausanne, , Switzerland
Countries
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References
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Schwitter J, Gold MR, Al Fagih A, Lee S, Peterson M, Ciuffo A, Zhang Y, Kristiansen N, Kanal E, Sommer T; Evera-MRI Study Investigators. Image Quality of Cardiac Magnetic Resonance Imaging in Patients With an Implantable Cardioverter Defibrillator System Designed for the Magnetic Resonance Imaging Environment. Circ Cardiovasc Imaging. 2016 May;9(5):e004025. doi: 10.1161/CIRCIMAGING.115.004025.
Gold MR, Sommer T, Schwitter J, Al Fagih A, Albert T, Merkely B, Peterson M, Ciuffo A, Lee S, Landborg L, Cerkvenik J, Kanal E; Evera MRI Study Investigators. Full-Body MRI in Patients With an Implantable Cardioverter-Defibrillator: Primary Results of a Randomized Study. J Am Coll Cardiol. 2015 Jun 23;65(24):2581-2588. doi: 10.1016/j.jacc.2015.04.047. Epub 2015 May 14.
Other Identifiers
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Evera MRI
Identifier Type: -
Identifier Source: org_study_id