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Evaluation of the Performances of the Sleep Disordered Breathing Monitoring Function in Pacemaker — DREAM  

Bradycardia Clinical Trial

Official title:
Evaluation of the Performances of the Sleep Disordered Breathing Monitoring Function in Pacemaker

Clinical Trial Summary

The IBSY04 clinical investigation is an European, prospective, multi-centre, non-randomized, longitudinal study.

Clinical Trial Description

The purpose of this study is to assess the performance of Sleep Disordered Breathing Monitoring function (SDB) in pacemakers by comparing device diagnostic data to the results of in-lab PolySomnoGraphy (PSG) recording during the same night ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01537718
Study type Interventional
Source LivaNova
Contact
Status Completed
Phase Phase 3
Start date March 2012
Completion date November 2012
View Details
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