The purpose of this clinical study is to confirm safety and effectiveness of the Medtronic Evera MRI ICD in a clinical MRI environment.
ID
Source
Brief title
Condition
- Cardiac arrhythmias
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary Objectives:
Safety: To demonstrate an acceptable MRI-related event-free rate.
Efficacy: To demonstrate that the proportion of patients whose ventricular
pacing capture threshold increases significantly one month post-MRI/waiting
period is similar between the MRI group and the control group.
Secondary outcome
Secondary Objectives:
- To demonstrate an acceptable system-related complication rate.
- To demonstrate the system integrity of the high-voltage ICD component after
MRI exposure.
- To demonstrate that the proportion of patients whose atrial pacing capture
threshold increases significantly one month post-MRI/waiting period is similar
between the MRI group and the control group.
Background summary
MRI has grown into one of the most widely used non-invasive imaging modalities.
Various medical disciplines rely on the
diagnostic capabilities of MRI because of its unique ability to discriminate
soft tissues.
As a result, there is a growing need for medical devices, which are MRI safe.
Medtronic already released a number of MRI
conditional pacemaker systems. The EveraMRI ICD is the world'sfirst
MRI-conditional ICD with no positioning restrictions.
Study objective
The purpose of this clinical study is to confirm safety and effectiveness of
the Medtronic Evera MRI ICD in a clinical MRI environment.
Study design
The Evera MRI study is a prospective, randomized (2:1), controlled, non-blinded
multi-site international study. The study
design is based on the 5076 MRI and the Advisa MRI SureScan pacing system
clinical study.
Subjects will have required follow up visits at baseline, implant, at 2 months,
9-12 weeks, one-week post-MRI/waiting
period, and one-month post-MRI/waiting period.
The MRI scans, including scans of the thoracic region, will be obtained for all
subjects randomized to the MRI group will occur at the 9-12 weeks visit. The
subjects in de control group have a wainting period.
Intervention
Two out of three subjects will obtain a MRI scan 9-12 weeks after the
implantation.
Study burden and risks
Two out of three subjects will undergo an MRI scan. For subjects in de control
group there is a waiting period. Therefor all
patients will come more often to the hopital for monitoring.
Earl Bakkenstraat 10
Heerlen 6422 PJ
NL
Earl Bakkenstraat 10
Heerlen 6422 PJ
NL
Age
Inclusion criteria
Patient is indicated for the first time for an ICD implantation
Patient is willing and able to undergo elective MRI scanning
Exclusion criteria
Patient has contraindication for an ICD.
Patient has contraindication for an elective MRI scan.
Design
Recruitment
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT02117414 |
| CCMO | NL48295.098.14 |