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

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ClinicalTrials.gov Identifier: NCT02117414
Recruitment Status : Completed
First Posted : April 21, 2014
Results First Posted : August 14, 2015
Last Update Posted : November 28, 2016
Sponsor:
Information provided by (Responsible Party):
Medtronic Cardiac Rhythm and Heart Failure

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Implantable Defibrillator Device: MRI scan sequences of the head and chest regions Other: Waiting Period Visit Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 275 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evera MRI Clinical Study
Study Start Date : April 2014
Actual Primary Completion Date : January 2015
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: MRI Scans

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




Primary Outcome Measures :
  1. MRI-related Events [ Time Frame: MRI procedure to 1-month post-MRI ]
    Number of patients free of MRI-related events. Events include MRI-related complications, sustained tachyarrhythmia, and MRI-related loss of pacing ability.

  2. Ventricular Pacing Capture Threshold (VPCT) [ Time Frame: Pre-MRI/Waiting Period visit to 1-month post-MRI/Waiting Period visit ]
    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.

  3. Ventricular Sensing Amplitude (R-wave) [ Time Frame: Pre-MRI/Waiting Period visit to 1-month post-MRI/Waiting Period visit ]
    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.


Secondary Outcome Measures :
  1. System-related Complications [ Time Frame: Implant to 4 months post-implant ]
    Number of subjects free of a system-related complication. The system includes the ICD and lead(s) attached to it.

  2. RV Defibrillation Impedance [ Time Frame: 1-month post-MRI/Waiting Period visit ]
    Number of subjects whose RV defibrillation impedance at the one-month post-MRI/waiting period visit is between 20 and 100 ohms

  3. Superior Vena Cava (SVC) Defibrillation Impedance [ Time Frame: 1-month post-MRI/Waiting Period visit ]
    Number of subjects whose SVC defibrillation impedance at the one-month post-MRI/waiting period visit is between 20 and 100 ohms

  4. Atrial Pacing Capture Threshold (APCT) [ Time Frame: Pre-MRI/Waiting Period visit to 1-month post-MRI/Waiting Period visit ]
    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.

  5. Atrial Sensing Amplitude [ Time Frame: MRI/waiting visit to 1-month post-MRI/Waiting visit ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02117414


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Sponsors and Collaborators
Medtronic Cardiac Rhythm and Heart Failure
Investigators
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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