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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.
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Ospedale Niguarda Ca Granda
Milan, Italy
Hospital Clinic de Barcelona
Barcelona, Spain
CHU de Vigo
Vigo, Spain
Primary Completion Date
June 1, 2019
Completion Date
March 1, 2020
Last Updated
November 14, 2017
Echocardiographic, polygraphy, electrocardiography measurements and sleep questionnaire
OTHER
Lead Sponsor
LivaNova
Data Source & Attribution
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