Austrian Wearable Cardioverter Defibrillator Registry

Heart Failure Clinical Trial

Official title:

Indications for and Experience With the Wearable Cardioverter Defibrillator (WCD) - Austrian WCD Registry

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02816047
• Other study ID #: KardioScherr1
• Status: Recruiting
• Start date: November 2014
• Est. completion date: March 2022

Study information

• Verified date: September 2021
• Source: Medical University of Graz
• Contact: Daniel Scherr, Assoz. Prof.
• Phone: 004331638512544
• Email: daniel.scherr[@]medunigraz.at
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 450
• Est. completion date: March 2022
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Related Conditions & MeSH terms

• Death, Sudden
• Death, Sudden, Cardiac
• Heart Failure
• Sudden Cardiac Arrest
• Sudden Death
• Tachycardia
• Tachycardia, Ventricular
• Ventricular Dysfunction
• Ventricular Fibrillation
• Ventricular Tachycardia

Intervention

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

Locations

Country	Name	City	State
Austria	Medical University of Graz/ Division of Cardiology	Graz

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Graz

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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