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

July 16, 2013 updated by: LivaNova
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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control
Procedure: control
waiting room
Experimental: MRI
experimental
Procedure: MRI exam
MRI exam

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

LivaNova

Investigators

  • Principal Investigator: Francisco LEYVA, Dr, Queen Elizabeth BIRMINGHAM UNITED KINGDOM

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Anticipated)

May 1, 2013

Study Completion (Anticipated)

May 1, 2013

Study Registration Dates

First Submitted

April 1, 2011

First Submitted That Met QC Criteria

April 22, 2011

First Posted (Estimate)

April 25, 2011

Study Record Updates

Last Update Posted (Estimate)

July 17, 2013

Last Update Submitted That Met QC Criteria

July 16, 2013

Last Verified

July 1, 2013

More Information

Terms related to this study

Other Study ID Numbers

  • IBMR01 - REPLY MRI STUDY

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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