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

Medtronic

Status: Completed

Conditions: Implantable Defibrillator

Treatments: Device: MRI scan sequences of the head and chest regions; Other: Waiting Period Visit

Study type: Interventional

Funder types: Industry

Identifiers

NCT02117414

Evera MRI

Details and patient eligibility

About

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).

Enrollment: 275 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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275 participants in 2 patient groups

MRI Group

Experimental group

Description:

Subjects randomized to the MRI group will undergo a series of MRI scans at the MRI visit (9-12 weeks post-implant).

Treatment:

Device: MRI scan sequences of the head and chest regions

Control Group

Sham Comparator group

Description:

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).

Treatment:

Other: Waiting Period Visit