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

November 10, 2017 updated by: LivaNova
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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed 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 Type

Interventional

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Milano, Italy, 20162
        • Ospedale Niguarda CA Granda
  • Spain
      • Barcelona, Spain, 08036
        • Hospital Clinic de Barcelona
      • Vigo, Spain
        • CHU de Vigo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Single arm study
only 1 arm - no comparison nor randomization in this study
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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).
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
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.
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

LivaNova

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Primary Completion (Anticipated)

June 1, 2019

Study Completion (Anticipated)

March 1, 2020

Study Registration Dates

First Submitted

July 15, 2016

First Submitted That Met QC Criteria

August 12, 2016

First Posted (Estimate)

August 17, 2016

Study Record Updates

Last Update Posted (Actual)

November 14, 2017

Last Update Submitted That Met QC Criteria

November 10, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ICSY03

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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