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. Identifier: NCT01341522
Recruitment Status : Withdrawn
First Posted : April 25, 2011
Last Update Posted : July 17, 2013
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Dual-chamber Pacemaker Placement Procedure: MRI exam Procedure: control Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Clinical Evaluation of the Sorin Group's REPLY MR-conditional Pacing System
Study Start Date : January 2012
Estimated Primary Completion Date : May 2013
Estimated Study Completion Date : May 2013

Arm Intervention/treatment
Active Comparator: Control
Procedure: control
waiting room

Experimental: MRI
Procedure: MRI exam
MRI exam

Primary Outcome Measures :
  1. assess the pacing system-, MRI- and implant procedure-related complication-free rate [ Time Frame: 1 month ]
  2. assess atrial and ventricular lead-related complication-free rate [ Time Frame: 3 months ]
  3. compare the changes in atrial and ventricular pacing thresholds before and after MRI, between MRI and control groups [ Time Frame: 3 months ]
  4. compare the changes in atrial and ventricular sense amplitude after MRI between MRI and control groups [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. Summarize all implant procedure, pacing system- and MRI procedure-related adverse events [ Time Frame: 12 months ]
  2. Summarize atrial and ventricular electrical performances [ Time Frame: 3 months ]
  3. Summarize atrial and ventricular lead handling [ Time Frame: 2 weeks ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01341522

Sponsors and Collaborators
Principal Investigator: Francisco LEYVA, Dr Queen Elizabeth BIRMINGHAM UNITED KINGDOM

Responsible Party: LivaNova Identifier: NCT01341522     History of Changes
Other Study ID Numbers: IBMR01 - REPLY MRI STUDY
First Posted: April 25, 2011    Key Record Dates
Last Update Posted: July 17, 2013
Last Verified: July 2013