Clinical Evaluation of the Sorin Group's REPLY MR-conditional Pacing System
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.
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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study:
18 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
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