Confirmatory Clinical Trial of the Evera MRI System for Conditionally-safe MRI Access

Completed · Not applicable

Conditions studied: Implantable Defibrillator

In brief

The purpose of the Evera MRI™ study is to confirm safety and efficacy of the Evera MRI ICD (Implantable cardioverter-defibrillator) System in the clinical MRI (Magnetic Resonance Imaging) environment when subjects receive MRI scans without positioning restrictions (MRI scans may occur anywhere on the body).

Key facts

Study ID

NCT02117414

Run by

Medtronic Cardiac Rhythm and Heart Failure

People needed

275

Starts

2014-04-01

Expected to finish

2015-09-01

Last updated by the study team

2016-11-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects who are indicated for implantation of an ICD at the time of study enrollment.
• 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).

You may not qualify if…

• Subjects with a history of significant tricuspid valvular disease .
• 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.
• Subjects with exclusion criteria required by local law (e.g., age, breastfeeding).

Where it is running

• 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

Full record on ClinicalTrials.gov

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