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

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
Sorin Group
ClinicalTrials.gov Identifier:
NCT01341522
First received: April 1, 2011
Last updated: July 16, 2013
Last verified: July 2013
  Purpose

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 Intervention Phase
Dual-chamber Pacemaker Placement
Procedure: MRI exam
Procedure: control
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Clinical Evaluation of the Sorin Group's REPLY MR-conditional Pacing System

Further study details as provided by Sorin Group:

Primary Outcome Measures:
  • assess the pacing system-, MRI- and implant procedure-related complication-free rate [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
  • assess atrial and ventricular lead-related complication-free rate [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
  • compare the changes in atrial and ventricular pacing thresholds before and after MRI, between MRI and control groups [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • compare the changes in atrial and ventricular sense amplitude after MRI between MRI and control groups [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Summarize all implant procedure, pacing system- and MRI procedure-related adverse events [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Summarize atrial and ventricular electrical performances [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Summarize atrial and ventricular lead handling [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: January 2012
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Control
Control
Procedure: control
waiting room
Experimental: MRI
experimental
Procedure: MRI exam
MRI exam

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01341522

Sponsors and Collaborators
Sorin Group
Investigators
Principal Investigator: Francisco LEYVA, Dr Queen Elizabeth BIRMINGHAM UNITED KINGDOM
  More Information

No publications provided

Responsible Party: Sorin Group
ClinicalTrials.gov Identifier: NCT01341522     History of Changes
Other Study ID Numbers: IBMR01 - REPLY MRI STUDY
Study First Received: April 1, 2011
Last Updated: July 16, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Italy: Ministry of Health
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Spain: Ministry of Health

ClinicalTrials.gov processed this record on September 18, 2014