This trial is active, not recruiting.

Condition implantable defibrillator
Treatments mri scan sequences of the head and chest regions, waiting period visit
Sponsor Medtronic Cardiac Rhythm Disease Management
Start date April 2014
End date January 2015
Trial size 275 participants
Trial identifier NCT02117414, Evera MRI


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).

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
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
(Sham Comparator)
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

Primary Outcomes

MRI-related Events
time frame: MRI procedure to 1-month post-MRI
Ventricular Pacing Capture Threshold (VPCT)
time frame: Pre-MRI/Waiting Period visit to 1-month post-MRI/Waiting Period visit
Ventricular Sensing Amplitude (R-wave)
time frame: Pre-MRI/Waiting Period visit to 1-month post-MRI/Waiting Period visit

Secondary Outcomes

System-related Complications
time frame: Implant to 4 months post-implant
Defibrillation Impedance
time frame: 1-month post-MRI/Waiting Period visit
Atrial Pacing Capture Threshold (APCT)
time frame: Pre-MRI/Waiting Period visit to 1-month post-MRI/Waiting Period visit
Atrial Sensing Amplitude
time frame: MRI/waiting visit to 1-month post-MRI/Waiting visit

Eligibility Criteria

Male or female participants at least 18 years old.

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).

Additional Information

Official title Evera MRI Clinical Study
Principal investigator Michael R Gold, MD, PhD
Trial information was received from ClinicalTrials.gov and was last updated in May 2015.
Information provided to ClinicalTrials.gov by Medtronic Cardiac Rhythm Disease Management.