Clinical Evaluation of the Sorin Group's REPLY MR-conditional Pacing System

Study Overview
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Brief Summary
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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.

Official Title
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Clinical Evaluation of the Sorin Group's REPLY MR-conditional Pacing System

Conditions
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Dual-chamber Pacemaker Placement

Intervention / Treatment
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* Procedure: MRI exam
* Procedure: control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who are candidates for dual-chamber pacemaker primo-implantation Patients who have indication for implantation of a dual-chamber pacemaker according to the American College of Cardiology and the American Heart Association Patients who are able and willing to undergo elective MRI scanning Patients who are scheduled for implant of a Reply DR pacemaker and Filtrea lead(s) only Patients who provided signed and dated informed consent Exclusion Criteria: Non MR-compatible device or material implant Chronic atrial fibrillation (for atrial lead evaluation) Incessant ventricular tachyarrhythmia (for ventricular lead evaluation) Inability to understand the purpose of the study or refusal to co-operate Unavailability for scheduled follow-ups at the implanting centre Already included in another clinical study that could affect the results of this study Inability or refusal to provide informed consent Patient is minor (less than 18-year old) Patient is pregnant (women of childbearing potential should have a negative pregnancy test prior to enrolment); Patient has life expectancy of less than 1 year Patient is forfeiture of freedom or under guardianship Any patient to whom a contra-indication from device and lead labeling applies

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control<br>Control | Procedure: control<br>* waiting room<br>|
| Experimental: MRI<br>experimental | Procedure: MRI exam<br>* MRI exam<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| Summarize atrial and ventricular lead handling |  | 2 weeks |