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

NCT ID: NCT01341522

Last Updated: 2013-07-17

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2013-05-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Control

Control

Group Type: ACTIVE_COMPARATOR

control

Intervention Type: PROCEDURE

waiting room

MRI

experimental

Group Type: EXPERIMENTAL

MRI exam

Intervention Type: PROCEDURE

MRI exam

Interventions

MRI exam

MRI exam

Intervention Type: PROCEDURE

control

waiting room

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

LivaNova

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Francisco LEYVA, Dr

Role: PRINCIPAL_INVESTIGATOR

Queen Elizabeth BIRMINGHAM UNITED KINGDOM

Other Identifiers

IBMR01 - REPLY MRI STUDY

Identifier Type: -

Identifier Source: org_study_id