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

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clinicaltrials.gov/study/NCT01341522
Is a
‌
Clinical study
0

Clinical Study attributes

NCT Number
NCT013415220
Trial Recruitment Size
00
Trial Sponsor
LivaNova
LivaNova
0
Clinical Trial Start Date
2012
0
Primary Completion Date
2013
0
Study Completion Date
2013
0
Clinical Trial Study Type
Interventional0
Interventional Trial Purpose
Diagnostic0
Intervention Type
Procedure0
Interventional Trial Phase
Phase 30
Official Name
Clinical Evaluation of the Sorin Group's REPLY MR-conditional Pacing System0
Last Updated
July 17, 2013
0
Allocation Type
Randomized0
Intervention Model
Parallel Assignment0
Masking Type
None (Open Label)0

Other attributes

Intervention Treatment
control0
MRI exam0
Study summary

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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