MedTrace Logo

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

NCT01341522 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2013-07-17

No results posted yet for this study

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

Interventions

PROCEDURE

MRI exam

MRI exam

PROCEDURE

control

waiting room

Sponsors & Collaborators

  • LivaNova

    lead INDUSTRY

Principal Investigators

  • Francisco LEYVA, Dr · Queen Elizabeth BIRMINGHAM UNITED KINGDOM

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2013-05-31
Completion
2013-05-31

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01341522 on ClinicalTrials.gov