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

Evera MRI Clinical Study

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).

Study Overview

• Status: Completed
• Conditions: Implantable Defibrillator
• Intervention / Treatment: Device: MRI scan sequences of the head and chest regions; Other: Waiting Period Visit

• Study Type: Interventional
• Enrollment (Actual): 275
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Liège, Belgium
    • Centre Hospitalier Regional de la Citadelle
• Canada
  • Quebec, Canada, G1V 4G5
    • Institut Universitaire de Cardiologie et de Pneumologie de Quebec (IUCPQ)
  • Alberta
    • Calgary, Alberta, Canada, T2N 4N1
      • University of Calgary
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H 3A7
      • Queen Elizabeth II Health Sciences Centre
• Chile
  • Santiago de Chile, Chile, 8320000
    • Hospital Clinico Pontificia Universidad Catolica
• Germany
  • Bonn, Germany
    • Universitätsklinikum Bonn
  • Dresden, Germany
    • Praxisklinik Herz und Gefäße
  • Hannover, Germany
    • Medizinische Hochschule Hannover
  • Jena, Germany
    • Universitätsklinikum Jena - Friedrich Schiller Universität
• Hong Kong
  • Hong Kong, Hong Kong
    • Queen Mary Hospital
• Hungary
  • Budapest, Hungary
    • Semmelweis Egyetem AOK
• India
  • Gurgaon, India
    • Medanta-The Medicity
• Italy
  • Taranto, Italy
    • Azienda Ospedaliera SS Annunziata
• Netherlands
  • Den Haag, Netherlands
    • HagaZiekenhuis - Locatie Leyweg
• Saudi Arabia
  • Riyadh, Saudi Arabia
    • Prince Sultan Cardiac Center
• Sweden
  • Uppsala, Sweden
    • Akademiska Sjukhuset
• Switzerland
  • Lausanne, Switzerland
    • Centre Hospitalier Universitaire Vaudois
• United States
  • California
    • Salinas, California, United States, 93901-3901
      • Central Coast Cardiology
    • Stanford, California, United States, 94305-2200
      • Stanford Hospitals & Clinics
  • Connecticut
    • Hartford, Connecticut, United States, 06102
      • Hartford Hospital
  • Florida
    • Orlando, Florida, United States, 32806-1215
      • Orlando Health
  • Illinois
    • Springfield, Illinois, United States, 62701-1003
      • Prairie Education & Research Cooperative (Springfield IL)
  • Iowa
    • West Des Moines, Iowa, United States, 50266
      • Iowa Heart
  • Maryland
    • Washington DC, Maryland, United States, 20010
      • Washington Hospital Center
  • Michigan
    • Marquette, Michigan, United States, 49855-5407
      • DLP Upper Michigan Cardiovascular Associates PC
  • Minnesota
    • Saint Louis Park, Minnesota, United States, 55426-4702
      • Park Nicollet Methodist Hospital
    • Saint Paul, Minnesota, United States, 55102-2568
      • United Heart and Vascular Clinic
  • Missouri
    • Kansas, Missouri, United States, 64111
      • Mid America Heart Institute (MAHI)
  • Nevada
    • Henderson, Nevada, United States, 89052
      • HealthCare Partners CCNV
  • New Jersey
    • Camden, New Jersey, United States, 08103-1489
      • Cooper University Hospital
    • Morristown, New Jersey, United States, 07960-6136
      • Morristown Memorial Hospital
  • New York
    • New York City, New York, United States, 10016
      • NYU Langone Medical Center
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27517
      • University of North Carolina (UNC) Memorial Hospital
    • Charlotte, North Carolina, United States, 28203
      • Carolinas Medical Center
  • Ohio
    • Cleveland, Ohio, United States, 44195-0001
      • Cleveland Clinic
    • Columbus, Ohio, United States, 43214-3907
      • OhioHealth Research Institute
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74104-4243
      • Oklahoma Heart Institute
  • Pennsylvania
    • Lancaster, Pennsylvania, United States, 17602-2222
      • Lancaster General Hospital
    • Pittsburgh, Pennsylvania, United States, 15213-2536
      • University of Pittsburgh Medical Center UPMC Presbyterian
  • South Carolina
    • Charleston, South Carolina, United States, 29425-8911
      • Medical University of South Carolina (MUSC)
  • Virginia
    • Norfolk, Virginia, United States, 23507-1904
      • Sentara Norfolk General Hospital
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53233
      • Aurora St. Luke's Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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).

Exclusion Criteria:

• 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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MRI Group; Subjects randomized to the MRI group will undergo a series of MRI scans at the MRI visit (9-12 weeks post-implant).	Device: MRI scan sequences of the head and chest regions; Non-diagnostic MRI scans
Sham Comparator: 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).	Other: Waiting Period Visit; Waiting period time will equate to 1 hour

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MRI-related Events	Number of patients free of MRI-related events. Events include MRI-related complications, sustained tachyarrhythmia, and MRI-related loss of pacing ability.	MRI procedure to 1-month post-MRI
Ventricular Pacing Capture Threshold (VPCT)	Number of successful patients, where success is defined as not increasing VPCT by more than 0.5V from pre-MRI/waiting to one month post.	Pre-MRI/Waiting Period visit to 1-month post-MRI/Waiting Period visit
Ventricular Sensing Amplitude (R-wave)	Number of successful patients who do not experience a decrease in ventricular sensing amplitude of >50% from the pre-MRI/waiting period to the one month post-MRI/waiting period, or a one month post-MRI/waiting value <3mV accompanied by a decrease of >25% from the pre-MRI/waiting period to the one month post-MRI/waiting period.	Pre-MRI/Waiting Period visit to 1-month post-MRI/Waiting Period visit

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
System-related Complications	Number of subjects free of a system-related complication. The system includes the ICD and lead(s) attached to it.	Implant to 4 months post-implant
RV Defibrillation Impedance	Number of subjects whose RV defibrillation impedance at the one-month post-MRI/waiting period visit is between 20 and 100 ohms	1-month post-MRI/Waiting Period visit
Superior Vena Cava (SVC) Defibrillation Impedance	Number of subjects whose SVC defibrillation impedance at the one-month post-MRI/waiting period visit is between 20 and 100 ohms	1-month post-MRI/Waiting Period visit
Atrial Pacing Capture Threshold (APCT)	Number of successful patients, where success is defined as not increasing APCT by more than 0.5V from pre-MRI/waiting to one month post.	Pre-MRI/Waiting Period visit to 1-month post-MRI/Waiting Period visit
Atrial Sensing Amplitude	Number of successful patients, where success is defined as not decreasing atrial sensing amplitude by more than 50% from pre-MRI/waiting to one month post.	MRI/waiting visit to 1-month post-MRI/Waiting visit

Collaborators and Investigators

• Sponsor: Medtronic Cardiac Rhythm and Heart Failure
• Investigators: Principal Investigator: Michael R Gold, MD, PhD, Medical University of South Carolina; Principal Investigator: Emanuel Kanal, MD, FACR, University of Pittsburgh Medical Center, USA; Principal Investigator: Juerg Schwitter, MD, University Hospital Lausanne (CHUV), Switzerland; Principal Investigator: Torsten Sommer, MD, German Red Cross Hospital (DRK) Neuwied, Germany

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: April 1, 2014
• Primary Completion (Actual): January 1, 2015
• Study Completion (Actual): September 1, 2015

Study Registration Dates

• First Submitted: April 16, 2014
• First Submitted That Met QC Criteria: April 17, 2014
• First Posted (Estimate): April 21, 2014

Study Record Updates

• Last Update Posted (Estimate): November 28, 2016
• Last Update Submitted That Met QC Criteria: October 15, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: Magnetic Resonance Imaging (MRI)
• Other Study ID Numbers: Evera MRI