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

LivaNova

Status and phase

Withdrawn

Phase 3

Conditions

Dual-chamber Pacemaker Placement

Treatments

Procedure: MRI exam

Procedure: control

Study type

Interventional

Funder types

Industry

Identifiers

NCT01341522

IBMR01 - REPLY MRI STUDY

Details and patient eligibility

About

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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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