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Austrian Wearable Cardioverter Defibrillator Registry

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ClinicalTrials.gov Identifier: NCT02816047
Recruitment Status : Unknown
Verified September 2021 by Scherr Daniel, MD, Medical University of Graz.
Recruitment status was:  Recruiting
First Posted : June 28, 2016
Last Update Posted : September 14, 2021
Sponsor:
Information provided by (Responsible Party):
Scherr Daniel, MD, Medical University of Graz

Study Description
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Brief Summary:

Background: The wearable cardioverter defibrillator (WCD) is an established treatment option for patients at high risk for ventricular tachycardia / ventricular fibrillation (VT/VF), either in whom this risk may only be temporarily present, or in patients at high risk for sudden cardiac death (SCD) or after VT/VF in whom an implantable cardioverter defibrillator (ICD is currently not possible for other reasons (infection, recent MI <40days, recent PCI/CABG < 3months etc.).

Methods: Comprehensive registry including all patients in Austria who received a WCD in 2010-2016.


Condition or disease Intervention/treatment
Heart Failure Ventricular Dysfunction Sudden Death Sudden Cardiac Arrest Ventricular Tachycardia Ventricular Fibrillation Other: Registry

Detailed Description:
Observational study to describe WCD indications, event rates, inappropriate shock rates and follow up (including ICD rate, shock rate, morbidity and mortality) in all Austrian WCD patients
Study Design
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Study Type : Observational
Estimated Enrollment : 450 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Indications for and Experience With the Wearable Cardioverter Defibrillator (WCD) - Austrian WCD Registry
Study Start Date : November 2014
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : March 2022

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Intervention Details:
  • Other: Registry
    Observational study to describe WCD indications, event rates, inappropriate shock rates and follow up (including ICD rate, shock rate, morbidity and mortality) in all Austrian WCD patients

Outcome Measures
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Primary Outcome Measures :
  1. Number of participants treated with WCD-treated ventricular arrhythmias [ Time Frame: during WCD wearing period; average of 1 year ]
    Number of participants treated with WCD-treated ventricular arrhythmias


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Comprehensive registry including all patients in all Austrian centers who received a WCD in 2010-2016.
Criteria

Inclusion Criteria:

  • patients, with a prescribed WCD according to guidelines in an austrian center
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02816047


Contacts
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Contact: Daniel Scherr, Assoz. Prof. 004331638512544 daniel.scherr@medunigraz.at

Locations
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Austria
Medical University of Graz/ Division of Cardiology Recruiting
Graz, Austria, 8036
Contact: Tanja Odeneg, MSc    004331638530199    tanja.odeneg@medunigraz.at   
Sponsors and Collaborators
Medical University of Graz
Investigators
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Principal Investigator: Daniel Scherr, Assoz. Prof. Medical University of Graz/ Division of Cardiology
More Information
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Responsible Party: Scherr Daniel, MD, Austrian Wearable Cardioverter Defibrillator Registry, Medical University of Graz
ClinicalTrials.gov Identifier: NCT02816047    
Other Study ID Numbers: KardioScherr1
First Posted: June 28, 2016    Key Record Dates
Last Update Posted: September 14, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: possible
Keywords provided by Scherr Daniel, MD, Medical University of Graz:
wearable cardioverter defibrillator
LifeVest
sudden death
defibrillator
Additional relevant MeSH terms:
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Tachycardia
Tachycardia, Ventricular
Ventricular Dysfunction
Ventricular Fibrillation
Death, Sudden, Cardiac
Death, Sudden
Heart Diseases
 Cardiovascular Diseases
Death
Pathologic Processes
Heart Arrest
Arrhythmias, Cardiac
Cardiac Conduction System Disease