Sleep Apnea, Arrhythmias and Cardiac Reverse Remodeling in Heart Failure Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Sleep Apnea, Arrhythmias and Cardiac Reverse Remodeling in Heart Failure Patients

Conditions
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Sleep Breathing Disorders in the Responders to Cardiac Resynchronisation Therapy (CRT)

Intervention / Treatment
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* Other: Echocardiographic, polygraphy, electrocardiography measurements and sleep questionnaire


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient successfully* implanted (de-novo implant, upgrade or replacement) with a LivaNova CRT-P device, according to the latest applicable CRT guidelines and IFU Signed and dated informed consent The subject will be available for postoperative follow-up beyond one year Exclusion Criteria: Chronic hypercapnic respiratory failure (under oxygen therapy - that could confound the results of this study) Already included in another clinical study that could confound the results of this study Not available to attend routine follow-up visits Not able to understand the aim of the study and its procedures Minor age (according to local regulation) Drug / alcohol addiction or abuse Known pregnancy Under guardianship

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Single arm study<br>only 1 arm - no comparison nor randomization in this study | Other: Echocardiographic, polygraphy, electrocardiography measurements and sleep questionnaire<br>* each patient is asked to undergo an echocardiographic, polygraphy, electrocardiography measurements, and respond to 2 sleep questionnaires, both at inclusion and after 6 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 |