Evera MRI Clinical Study

Completed

• Conditions: arrhythmia; 10007521

• Registration Number: NL-OMON53163
• Lead Sponsor: Medtronic Trading NL BV

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 45

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.

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary Objectives:<br /><br>Safety: To demonstrate an acceptable MRI-related event-free rate.<br /><br><br /><br>Efficacy: To demonstrate that the proportion of patients whose ventricular<br /><br>pacing capture threshold increases significantly one month post-MRI/waiting<br /><br>period is similar between the MRI group and the control group.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary Objectives:<br /><br>- To demonstrate an acceptable system-related complication rate.<br /><br>- To demonstrate the system integrity of the high-voltage ICD component after<br /><br>MRI exposure.<br /><br>- To demonstrate that the proportion of patients whose atrial pacing capture<br /><br>threshold increases significantly one month post-MRI/waiting period is similar<br /><br>between the MRI group and the control group.<br /><br></p><br>