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Cologne Register of Wearable Defibrillator (CRWD)

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ClinicalTrials.gov Identifier: NCT02073942
Recruitment Status : Completed
First Posted : February 28, 2014
Last Update Posted : October 19, 2018
Sponsor:
Collaborator:
Zoll Medical Corporation
Information provided by (Responsible Party):
Guido Michels, University of Cologne

Brief 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). The Cologne register of wearable defibrillator (CRWD) is a prospective register for all patient with an indication of wearable defibrillator.

Condition or disease
Myocardial Infarction Ventricular Dysfunction Myocarditis

Study Type : Observational [Patient Registry]
Actual Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 1 Month
Study Start Date : February 2014
Actual Primary Completion Date : December 31, 2017
Actual Study Completion Date : March 31, 2018

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Number of arrhythmic events and arrhythmic risk factors during bridging therapy with wearable defibrillator [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. Total mortality [ Time Frame: 1 months and 3 months ]
    Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Adult patients with an indication for wearable defibrillator
Criteria

Inclusion Criteria:

  • Adult patients with an indication for wearable defibrillator

Exclusion Criteria:

  • childs

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02073942


Locations
Germany
University of Cologne
Cologne, Germany, 50937
Sponsors and Collaborators
University of Cologne
Zoll Medical Corporation

Responsible Party: Guido Michels, PD Dr., University of Cologne
ClinicalTrials.gov Identifier: NCT02073942     History of Changes
Other Study ID Numbers: 14-050
First Posted: February 28, 2014    Key Record Dates
Last Update Posted: October 19, 2018
Last Verified: October 2018

Additional relevant MeSH terms:
Myocarditis
Infarction
Myocardial Infarction
Ventricular Dysfunction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Cardiomyopathies