Heart FailureNCT02816047
Austrian Wearable Cardioverter Defibrillator Registry
An observational study of Heart Failure and Ventricular Dysfunction, run by Medical University of Graz at 1 site in Austria.
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Heart Failure, Ventricular Dysfunction, Sudden Death
- What is being tested?
- Registry
- How many people
- 450 participants
- Where
- 1 siteAustria
- Study dates
- Nov 2014to Mar 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Comprehensive registry including all patients in all Austrian centers who received a WCD in 2010-2016.
Who may be able to join
- patients, with a prescribed WCD according to guidelines in an austrian center
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Austria1 site, 1 recruiting
- Recruiting
Medical University of Graz/ Division of Cardiology
Graz, 8036
Tanja Odeneg, MSc, 004331638530199, tanja.odeneg@medunigraz.at
About this study
Official title: Indications for and Experience With the Wearable Cardioverter Defibrillator (WCD) - Austrian WCD Registry
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.
Read the 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
- Conditions
- Heart Failure, Ventricular Dysfunction, Sudden Death, Sudden Cardiac Arrest, Ventricular Tachycardia, Ventricular Fibrillation
- Being tested
- Registry
- Keywords
- wearable cardioverter defibrillator, LifeVest, sudden death, defibrillator
- Medical subject headings
- Heart Failure, Ventricular Dysfunction, Death, Sudden, Death, Sudden, Cardiac, Tachycardia, Ventricular, Ventricular Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RegistryOther
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
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants treated with WCD-treated ventricular arrhythmias
Number of participants treated with WCD-treated ventricular arrhythmias
Measured: during WCD wearing period; average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2016 (estimated)
- Study startNov 2014
- Primary completionDec 2021 (estimated)
- Study completionMar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Medical University of GrazThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Scherr Daniel, MD, Medical University of Graz
- Investigators
- Daniel Scherr, Assoz. Prof., Principal investigator, Medical University of Graz/ Division of Cardiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02816047
- Sponsor's protocol ID
- KardioScherr1
- Status last verified
- Sep 2021
- First submitted
- 17 May 2016
- Last updated
- 14 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided: possible
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Indications for and Experience With the Wearable Cardioverter Defibrillator (WCD) - Austrian WCD Registry
- ClinicalTrials.gov ID
- NCT02816047
- Acronym / sponsor ID
- KardioScherr1
- Conditions
- Heart Failure, Ventricular Dysfunction, Sudden Death, Sudden Cardiac Arrest, Ventricular Tachycardia, Ventricular Fibrillation
- Keywords
- wearable cardioverter defibrillator, LifeVest, sudden death, defibrillator
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Mar 2022 (estimated)
- First posted
- 28 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Comprehensive registry including all patients in all Austrian centers who received a WCD in 2010-2016.
Key inclusion criteria (1 listed)
- patients, with a prescribed WCD according to guidelines in an austrian center
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RegistryObservational 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 | Other | – |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2021.
- Individual participant dataSharing planned: Undecided. possible
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Scherr, Assoz. Prof. principal investigator
Medical University of Graz/ Division of Cardiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure and Ventricular Dysfunction, run by Medical University of Graz at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Daniel Scherr, Assoz. Prof. (004331638512544, daniel.scherr@medunigraz.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants treated with WCD-treated ventricular arrhythmias (time frame: during WCD wearing period; average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2021; AzTrials last refreshed its copy on 4 Nov 2026.