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

NCT ID: NCT02870647

Last Updated: 2017-11-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Completion Date

2020-03-31

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.

Conditions

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Single arm study

only 1 arm - no comparison nor randomization in this study

Group Type OTHER

Echocardiographic, polygraphy, electrocardiography measurements and sleep questionnaire

Intervention Type 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

Interventions

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Echocardiographic, polygraphy, electrocardiography measurements and sleep questionnaire

each patient is asked to undergo an echocardiographic, polygraphy, electrocardiography measurements, and respond to 2 sleep questionnaires, both at inclusion and after 6 months

Intervention Type OTHER

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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LivaNova

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Ospedale Niguarda Ca Granda

Milan, , Italy

Site Status

Hospital Clinic de Barcelona

Barcelona, , Spain

Site Status

CHU de Vigo

Vigo, , Spain

Site Status

Countries

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Italy Spain

Other Identifiers

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ICSY03

Identifier Type: -

Identifier Source: org_study_id