NCT01341522

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

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: LivaNova · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Dual-chamber Pacemaker Placement

Interventions

Type	Name	Description
PROCEDURE	MRI exam	MRI exam
PROCEDURE	control	waiting room

Timeline

• Start date: 2012-01-01
• Primary completion: 2013-05-01
• Completion: 2013-05-01
• First posted: 2011-04-25
• Last updated: 2013-07-17