Evera MRIâ?¢ Study - To confirm safety and efficacy of the Evera MRIâ?¢, an implantable cardioverter defibrillator System when subjects implanted with the device receive MRI scans
- Conditions
- Health Condition 1: null- Subjects who are indicated for implantation of an ICD at the time of studyenrollment.o Subjects who are able to undergo a pectoral implant.
- Registration Number
- CTRI/2014/07/004787
- Lead Sponsor
- Medtronic Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 275
Subjects who are indicated for implantation of an ICD at the time of study
enrollment.
o Subjects who are able to undergo a pectoral implant.
o Subjects who are receiving an ICD for the first time.
o Subjects who are able and willing to undergo elective MRI scanning without
sedation.7,8
o 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)
Subjects with a history of significant tricuspid valvular disease9.
o Subjects for whom a single dose of 1.0mg dexamethasone sodium phosphate
and/or dexamethasone acetate may be contraindicated.
o Subjects who require a legally authorized representative to obtain informed
consent.
o Subjects undergoing device upgrades, change-outs, lead extractions, and/or lead
or device revisions.
o Subjects with abandoned or capped leads.
o 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).
o 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).
o Subjects with medical conditions that preclude the testing required by the CIP or
limit study participation.
o 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.
o 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.10
o Subjects with exclusion criteria required by local law (e.g., age, breastfeeding).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method