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Permanent cardiac pacemakers have represented a contraindication to Magnetic Resonance Imaging (MRI). Strong static, gradient and radiofrequency fields used for MRI are thought to be detrimental to pacemaker function and possibly cause harm to patients undergoing MRI examinations. A previous study has shown that MRI is indicated in 17% of all patients with pacemakers within 12 months of device placement , which demonstrates the need of practical, safe approach for performing MRI on pacemaker patients. A new Reply MR-conditional pacing system is developed by Sorin Group for safe use in the MRI environment. The new pacing system is composed by the Reply pacemaker and the Filtrea bradycardia pacing leads. This study intends to demonstrate the safety and the efficacy in the MRI environment of the Sorin Group Reply MR-conditional pacing system.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Active Comparator | Control |
|
| MRI | Experimental | experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MRI exam | Procedure | MRI exam |
| |
| control |
| Measure | Description | Time Frame |
|---|---|---|
| assess the pacing system-, MRI- and implant procedure-related complication-free rate | 1 month | |
| assess atrial and ventricular lead-related complication-free rate | 3 months | |
| compare the changes in atrial and ventricular pacing thresholds before and after MRI, between MRI and control groups | 3 months | |
| compare the changes in atrial and ventricular sense amplitude after MRI between MRI and control groups | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Summarize all implant procedure, pacing system- and MRI procedure-related adverse events | 12 months | |
| Summarize atrial and ventricular electrical performances | 3 months | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Francisco LEYVA, Dr | Queen Elizabeth BIRMINGHAM UNITED KINGDOM | Principal Investigator |
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| Procedure |
waiting room |
|
| Summarize atrial and ventricular lead handling |
| 2 weeks |