Clinical Investigation of the ENO/TEO/OTO Pacing System under MRI environment

Completed

Conditions: Pacemaker system safety and efficacy in an MRI environment
Pacemaker safety and efficacy in an MRI environment

Registration Number: NL-OMON50027

Lead Sponsor: Microport CRM B.V.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 15

Inclusion Criteria

Implanted with an ENO/TEO/OTO single or dual chamber pacemaker system with Vega
lead(s).
Agree to undergo a non-clinically indicated MRI scan, without intravenous
injection or sedation.
Informed consent.
Available for follow-up.

Exclusion Criteria

Included in another study, that may confound results in this study.
Presence of other cardiac implants.
Presence of other - non-MRI compatible - implants.
History of brain aneurysm with ferromagnetic clipping.
Presence of cochlear implants.
Tattoos in area where MRI coil is placed.
Planned cardiac surgery within 3 months of inclusion.
Planned MRI scan within 3 months of inclusion.
Aged under 18, in detention, or under guardianship.
Known pregnancy, breast-feeding or of child-bearing age without adequate
contraceptive method.
Unavailable for follow-up.
Conflict of interest with sponsor, investigator or institution.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The study has 1 primary endpoint: absence of MRI related complications within 1<br /><br>month post MRI exam.<br /><br>An MRI related complication is defined as a Serious Adverse Event leading to<br /><br>death, or an invasive intervention, or a Device Deficiency which has led to<br /><br>loss of pacemaker functionality, as adjucated by an independent Clinical Events<br /><br>Committee.<br /><br>The primary endpoint will be assessed seperately for both arms (1.5 Tesla, 3.0<br /><br>Tesla).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The 4 secondary endpoints are:<br /><br><br /><br>- stability of the ventricular pacing threshold (threshold increase < 0,5 Volt<br /><br>at 0.5 milliseconds)<br /><br>- stability of the atrial pacing threshold (threshold increase < 0,5 Volt at<br /><br>0.5 milliseconds)<br /><br>- stability of the ventricular sensing threshold (sensing amplitude decrease <<br /><br>50% of the initial value, unless this value was 4mV or less: in which case the<br /><br>patient will not be part of the analysis)<br /><br>- stability of the atrial sensing threshold (sensing amplitude decrease < 50%<br /><br>of the initial value, unless this value was 1mV or less: in this case the<br /><br>patient will not be part of the analysis<br /><br><br /><br>Also the secondary endpoints will be analysed for each arm (1,5 Tesla; 3.0<br /><br>Tesla) seperately.</p><br>