Austrian Wearable Cardioverter Defibrillator Registry | NCT02816047

Studies
Austrian Wearable Cardioverter Defibrillator Registry

NCT02816047

Sponsor

Medical University of Graz

Status

Unknown status

Last Update Posted

Sep 14, 2021Actual

Enrollment

450Estimated

Phase

Not provided

Conditions

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

Interventions

Registry

Countries

Austria

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2014

Primary Completion Date

Dec 2021Estimated

Completion Date

Mar 2022Estimated

First Submitted Date

May 17, 2016

First Submission Date that Met QC Criteria

Jun 23, 2016

First Posted Date

Jun 28, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 13, 2021

Last Update Posted Date

Sep 14, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Scherr Daniel, MD, Austrian Wearable Cardioverter Defibrillator Registry, Medical University of GrazPrincipal Investigator

Lead Sponsor

Medical University of GrazOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

450Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Daniel Scherr, Assoz. Prof.	Contact	004331638512544		daniel.scherr@medunigraz.at

Overall Officials

Name	Affiliation	Role
Daniel Scherr, Assoz. Prof.	Medical University of Graz/ Division of Cardiology	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Medical University of Graz/ Division of Cardiology	Recruiting	Graz		8036	Austria

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

possible

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006333	Heart Failure
D018754	Ventricular Dysfunction
D003645	Death, Sudden
D016757	Death, Sudden, Cardiac
D017180	Tachycardia, Ventricular
D014693	Ventricular Fibrillation

Ancestor Terms

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D003643	Death
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D012042	Registries

Ancestor Terms

ID	Term
D003625	Data Collection
D004812	Epidemiologic Methods
D008919	Investigative Techniques
D011996	Records

Browse Leaves

Not provided

Browse Branches

Not provided