Myocardial InfarctionNCT02073942
Cologne Register of Wearable Defibrillator (CRWD)
An observational study of Myocardial Infarction and Ventricular Dysfunction, run by University of Cologne at 1 site in Germany.
Trial summary
The wearable cardiac defibrillator (WCD) is an alternative to the implantation of cardioverter defibrillator (ICD) for patients at high risk for sudden cardiac death (mostly bridging therapy). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Myocardial Infarction, Ventricular Dysfunction, Myocarditis
- How many people
- 100 participants
- Where
- 1 siteGermany
- Study dates
- Feb 2014to 31 Mar 2018
- How long will I take part?
- 1 Month
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adult patients with an indication for wearable defibrillator
Who may be able to join
- Adult patients with an indication for wearable defibrillator
Who cannot join
- childs
Trial locations and contacts
1 site in 1 country.
About this study
The wearable cardiac defibrillator (WCD) is an alternative to the implantation of cardioverter defibrillator (ICD) for patients at high risk for sudden cardiac death (mostly bridging therapy). The Cologne register of wearable defibrillator (CRWD) is a prospective register for all patient with an indication of wearable defibrillator.
- Conditions
- Myocardial Infarction, Ventricular Dysfunction, Myocarditis
- Medical subject headings
- Myocardial Infarction, Ventricular Dysfunction, Myocarditis
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of arrhythmic events and arrhythmic risk factors during bridging therapy with wearable defibrillator
Measured: 3 years
Secondary outcomes (1)
Total mortality
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Measured: 1 months and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2014 (estimated)
- Study startFeb 2014
- Primary completion31 Dec 2017
- Study completion31 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- University of Cologne
- Sponsor type
- University, hospital or other
- Collaborators
- Zoll Medical Corporation
- Responsible party
- Principal investigator, Guido Michels, University of Cologne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02073942
- Sponsor's protocol ID
- 14-050
- Status last verified
- Oct 2018
- First submitted
- 24 Feb 2014
- Last updated
- 19 Oct 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cologne Register of Wearable Defibrillator (CRWD)
- ClinicalTrials.gov ID
- NCT02073942
- Acronym / sponsor ID
- 14-050
- Conditions
- Myocardial Infarction, Ventricular Dysfunction, Myocarditis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of CologneUniversity, hospital or other
- Collaborators
- Zoll Medical Corporation
- Study start
- Feb 2014
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Mar 2018 (actual)
- First posted
- 28 Feb 2014 (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.
The wearable cardiac defibrillator (WCD) is an alternative to the implantation of cardioverter defibrillator (ICD) for patients at high risk for sudden cardiac death (mostly bridging therapy). The Cologne register of wearable defibrillator (CRWD) is a prospective register for all patient with an indication of wearable defibrillator.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Month
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with an indication for wearable defibrillator
Key inclusion criteria (1 listed)
- Adult patients with an indication for wearable defibrillator
Key exclusion criteria (1 listed)
- childs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of arrhythmic events and arrhythmic risk factors during bridging therapy with wearable defibrillator
Time frame: 3 years
1 secondary outcome
Total mortality
Time frame: 1 months and 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Myocardial Infarction and Ventricular Dysfunction, run by University of Cologne at 1 site in Germany.
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 1 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: finished, as of the sponsor's last update on 19 Oct 2018. 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 Germany. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of arrhythmic events and arrhythmic risk factors during bridging therapy with wearable defibrillator (time frame: 3 years). 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 19 Oct 2018.