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Clinical Trial Summary

Prospective, international, non-randomized, multicentre, clinical investigation (phase IV). The aim of the study is to investigate the correlation between HF, severe SBD, and AF in CRT-P patients at 6 months.


Clinical Trial Description

The primary objective is to estimate the change in severity of Sleep Breathing Disorders (SBD) in patients with or without reverse remodeling, in de-novo or upgrade implants, after 6 month follow-up.

The main secondary objective is to assess the prevalence, type and evolution of the SBD, co-morbidities and major adverse cardiac events in each subgroup of HF patients (based on the etiology), up to 12 months follow-up period.

Predictors of the clinical outcomes will be investigated. ;


Study Design


Related Conditions & MeSH terms

  • Heart Failure
  • Sleep Breathing Disorders in the Responders to Cardiac Resynchronisation Therapy (CRT)

NCT number NCT02870647
Study type Interventional
Source LivaNova
Contact
Status Withdrawn
Phase Phase 4
Completion date March 2020