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

NCT01341522 | Withdrawn Phase 3 DMC

• 1 other identifier: IBMR01 - REPLY MRI STUDY
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (4)

• assess the pacing system-, MRI- and implant procedure-related complication-free rate

  1 month

• assess atrial and ventricular lead-related complication-free rate

  3 months

• compare the changes in atrial and ventricular pacing thresholds before and after MRI, between MRI and control groups

  3 months

• compare the changes in atrial and ventricular sense amplitude after MRI between MRI and control groups

  3 months

Secondary Outcomes (3)

• Summarize all implant procedure, pacing system- and MRI procedure-related adverse events

  12 months

• Summarize atrial and ventricular electrical performances

  3 months

• Summarize atrial and ventricular lead handling

  2 weeks

Study Arms (2)

Control

ACTIVE COMPARATOR

Control

Procedure: control

MRI

EXPERIMENTAL

experimental

Procedure: MRI exam

Interventions

MRI exam PROCEDURE

MRI exam

MRI

control PROCEDURE

waiting room

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• LivaNova: lead

Study Officials

• Francisco LEYVA, Dr

  Queen Elizabeth BIRMINGHAM UNITED KINGDOM

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2011
• First Posted: April 25, 2011
• Study Start: January 1, 2012
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: July 17, 2013

Record last verified: 2013-07