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Assessment of the MRI Solution: KORA 100 and Beflex Pacing Leads System

NCT02175797 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2019-04-23

No results posted yet for this study

Summary

The purpose of this study is to report the stability of atrial and ventricular leads by absence of effect of the MRI exam on the pacing and sensing threshold and to report the safety based on the serious adverse events.

Conditions

  • Bradycardia

Interventions

DEVICE

MRI

at least 6 weeks after the implantation of the pacemaker a MRI exam is performed

Sponsors & Collaborators

  • MicroPort CRM

    lead INDUSTRY

Principal Investigators

  • Arnaud Mr SAVOURE, cardiologist · CHU Charles Nicolle - 1 rue Germont, 76000 ROUEN

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-02-28
Primary Completion
2014-08-31
Completion
2014-08-31

Countries

  • France

Study Locations

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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 NCT02175797 on ClinicalTrials.gov