Austrian Wearable Cardioverter Defibrillator Registry

NCT02816047 | Unknown DMC

• 1 other identifier: KardioScherr1
• Study Type: observational
• Target: 450
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure; Ventricular Dysfunction; Sudden Death; Sudden Cardiac Arrest; Ventricular Tachycardia; Ventricular Fibrillation

Keywords

wearable cardioverter defibrillator; LifeVest; sudden death; defibrillator

Outcome Measures

Primary Outcomes (1)

• Number of participants treated with WCD-treated ventricular arrhythmias

  Number of participants treated with WCD-treated ventricular arrhythmias

  during WCD wearing period; average of 1 year

Interventions

Registry OTHER

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Comprehensive registry including all patients in all Austrian centers who received a WCD in 2010-2016.

You may qualify if:

• patients, with a prescribed WCD according to guidelines in an austrian center

Sponsors & Collaborators

• Medical University of Graz: lead

Study Sites (1)

Medical University of Graz/ Division of Cardiology

Graz, 8036, Austria

RECRUITING

MeSH Terms

Conditions

Heart Failure; Ventricular Dysfunction; Death, Sudden; Death, Sudden, Cardiac; Tachycardia, Ventricular; Ventricular Fibrillation

Interventions

Registries

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Heart Arrest; Tachycardia; Arrhythmias, Cardiac; Cardiac Conduction System Disease

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Records; Organization and Administration; Health Services Administration; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Daniel Scherr, Assoz. Prof.

  Medical University of Graz/ Division of Cardiology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Daniel Scherr, Assoz. Prof.

CONTACT

004331638512544; daniel.scherr@medunigraz.at

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Austrian Wearable Cardioverter Defibrillator Registry

Study Record Dates

• First Submitted: May 17, 2016
• First Posted: June 28, 2016
• Study Start: November 1, 2014
• Primary Completion: December 1, 2021
• Study Completion: March 1, 2022
• Last Updated: September 14, 2021

Record last verified: 2021-09

Locations

AU (1)