Primary endpoint of the study is the confirmation of the safety and effectiveness of the ENO/TEO/OTO pacing system in an 1.5 Tesla and 3.0 Tesla environment, without scanning exclusion zone.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Pacemaker system safety and efficacy in an MRI environment
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The study has 1 primary endpoint: absence of MRI related complications within 1
month post MRI exam.
An MRI related complication is defined as a Serious Adverse Event leading to
death, or an invasive intervention, or a Device Deficiency which has led to
loss of pacemaker functionality, as adjucated by an independent Clinical Events
Committee.
The primary endpoint will be assessed seperately for both arms (1.5 Tesla, 3.0
Tesla).
Secondary outcome
The 4 secondary endpoints are:
- stability of the ventricular pacing threshold (threshold increase < 0,5 Volt
at 0.5 milliseconds)
- stability of the atrial pacing threshold (threshold increase < 0,5 Volt at
0.5 milliseconds)
- stability of the ventricular sensing threshold (sensing amplitude decrease <
50% of the initial value, unless this value was 4mV or less: in which case the
patient will not be part of the analysis)
- stability of the atrial sensing threshold (sensing amplitude decrease < 50%
of the initial value, unless this value was 1mV or less: in this case the
patient will not be part of the analysis
Also the secondary endpoints will be analysed for each arm (1,5 Tesla; 3.0
Tesla) seperately.
Background summary
Collection of data concerning the safety and effectiveness of the ENO/TEO/OTO
pacing system in an MRI environment.
Study objective
Primary endpoint of the study is the confirmation of the safety and
effectiveness of the ENO/TEO/OTO pacing system in an 1.5 Tesla and 3.0 Tesla
environment, without scanning exclusion zone.
Study design
Interventional, prospective, muliti-centre, open label, two-arm, parallel,
non-comparative, non-randomised study.
Intervention
An MRI exam at minimum 6 weeks post pacing system implant, within 8 weeks of
enrolment of the patient in the study.
Study burden and risks
There is no additional risk for the patient; additional burden consists of a
40-minute MRI exam, maximum duration 40 minutes (60 minutes when preparation
and conclusion is taken into account).
Paasheuvelweg 25
Amsterdam 1105 BP
NL
Paasheuvelweg 25
Amsterdam 1105 BP
NL
Listed location countries
Age
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.
Design
Recruitment
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 | NCT03811691 |
| CCMO | NL71015.075.19 |