Status:

COMPLETED

Predictive Factors of a Successful Implant of the CapsureFix MRI Model 5086

Lead Sponsor:

Medtronic Cardiac Rhythm and Heart Failure

Collaborating Sponsors:

Medtronic

Conditions:

Bradyarrhythmia

Eligibility:

All Genders

18+ years

Brief Summary

Pacing leads are key elements of a pacing system as their proper functioning is one of the major factors affecting the long term performance of the whole system. Success of a pacing lead implant can ...

Eligibility Criteria

Inclusion

  • Patient older than 18
  • Patient implanted with a fully automatic ICD and remotely followed-up,
  • Patient geographically stable and able to attend FU at investigative site
  • Patient who signed a data release authorization form,

Exclusion

  • Patient whose mental or physical capacity impedes to give an informed data release authorization,
  • Patient already enrolled in a clinical study whose procedures may interfere with the results of the present study,
  • Patients in New York Heart Association (NYHA) class IV

Key Trial Info

Start Date :

May 1 2011

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

December 1 2013

Estimated Enrollment :

409 Patients enrolled

Trial Details

Trial ID

NCT01522755

Start Date

May 1 2011

End Date

December 1 2013

Last Update

July 2 2025

Active Locations (1)

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1

Centre Hospitalier Regionnal d'Orléans La Source

Orléans, France, 45067