Clinical Investigation of ENO/TEO/OTO Pacing System Under MRI Environment
NCT ID: NCT03811691
Last Updated: 2021-06-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
270 participants
INTERVENTIONAL
2019-07-18
2023-08-31
Brief Summary
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Detailed Description
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The primary objective is to confirm the clinical safety of the ENO/TEO/OTO pacing system when used under 1.5 and 3 Tesla specific MRI conditions without scan exclusion zone.
The study secondary main objectives are aiming to assess the performance of the MR conditional pacing system in the right atrium and ventricle at 1 month following the MRI scan:
* Stability of the Pacing Capture Threshold
* Stability of the lead sensed amplitude
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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1.5 Tesla MRI Scan
Subjects will undergo 1.5T MRI exam
MRI exam
Pacing system safety and stability under MRI scan environment
3 Tesla MRI Scan
Subjects will undergo 3T MRI exam
MRI exam
Pacing system safety and stability under MRI scan environment
Interventions
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MRI exam
Pacing system safety and stability under MRI scan environment
Eligibility Criteria
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Inclusion Criteria
* Already implanted in the left or right pectoral region for at least 6 weeks with:
* ENO, TEO or OTO single chamber rate response (SR) pacemaker with a VEGA pacing lead, or
* ENO, TEO or OTO dual chamber rate response (DR) pacemaker with two VEGA pacing leads.
* Implanted pacing system must fulfill the following parameters:
* Battery impedance is \< 5 Kilo Ohm (kΩ)
* Pacing capture threshold value is ≤ 2 Volts (V) at 0.35 millisecond (ms)
* Lead impedance value between 200Ω and 3000Ω
* No diaphragmatic or pectoral stimulation at 5V/1ms
* P-wave minimum sensed amplitude ≥ 1mV for patients with sinus rhythm
* R-wave minimum sensed amplitude ≥ 4mV for patients with spontaneous conduction rhythm
* Must agree to undergo a non clinically-indicated MRI scan without intravenous injection and without sedation;
* Have reviewed, signed and dated informed consent.
Subjects who meet any of the following criteria are not eligible to be included in the study:
* Included in another clinical study that could confound the results of this study such as studies involving intra-cardiac device;
* Have other active or abandoned cardiac implants already implanted;
* Have other active or passive non MR conditional devices implanted such as metallic foreign body;
* Have a history of brain aneurysm with ferromagnetic clipping;
* Have a planned cardiac surgery within the 3 months of inclusion;
* Have a medical MRI examination prescription planned within the 3 months of inclusion;
* Age less than 18 years old or under guardianship or kept in detention;
* Known pregnancy, women breastfeeding or in childbearing age without an adequate contraceptive method ;
* Be unavailable for the scheduled follow-up associated with this clinical study or refusal to cooperate.
18 Years
ALL
Yes
Sponsors
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MicroPort CRM
INDUSTRY
Responsible Party
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Locations
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MicroPort CRM
Clamart, Haut de Seine, France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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IBSY06 - CAPRI
Identifier Type: -
Identifier Source: org_study_id
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