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Strategy changes.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single arm study | Other | only 1 arm - no comparison nor randomization in this study |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Echocardiographic, polygraphy, electrocardiography measurements and sleep questionnaire | Other | each patient is asked to undergo an echocardiographic, polygraphy, electrocardiography measurements, and respond to 2 sleep questionnaires, both at inclusion and after 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| The change in severity of SBD (by means of AHI as determined by PG), in the responders to CRT (reverse remodeling, delta LVESV=>15%) compared to the non-responders, at 6-month follow-up after implant (de-novo or upgrade). | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| The main secondary objective is to assess the type of the SBD in each subgroup of HF patients (based on the etiology), up to 12 months follow-up period. | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ospedale Niguarda Ca Granda | Milan | 20162 | Italy | |||
| Hospital Clinic de Barcelona |
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| Barcelona |
| 08036 |
| Spain |
| CHU de Vigo | Vigo | Spain |