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

Launched by LIVANOVA · Apr 22, 2011

Keywords

ClinConnect Summary

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Gender

ALL

Eligibility criteria

• 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