We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Cologne Register of Wearable Defibrillator (CRWD)

This study is currently recruiting participants.
Verified October 2017 by Guido Michels, University of Cologne
Sponsor:
ClinicalTrials.gov Identifier:
NCT02073942
First Posted: February 28, 2014
Last Update Posted: October 26, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Zoll Medical Corporation
Information provided by (Responsible Party):
Guido Michels, University of Cologne
February 24, 2014
February 28, 2014
October 26, 2017
February 2014
December 31, 2017   (Final data collection date for primary outcome measure)
Number of arrhythmic events and arrhythmic risk factors during bridging therapy with wearable defibrillator [ Time Frame: 3 years ]
Same as current
Complete list of historical versions of study NCT02073942 on ClinicalTrials.gov Archive Site
  • Total mortality [ Time Frame: 1 months and 3 months ]
  • Quality of life [ Time Frame: 1 months and 3 months ]
    SF-12v2® Health Survey questionnaire
  • Depression [ Time Frame: 1 months and 3 months ]
    BDI-II questionnaire
  • Anxiety [ Time Frame: 1 months and 3 months ]
    STAI-G Form X1 questionnaire
Total mortality [ Time Frame: 1 months and 3 months ]
Not Provided
Not Provided
 
Cologne Register of Wearable Defibrillator (CRWD)
Not Provided
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.
Not Provided
Observational [Patient Registry]
Observational Model: Case-Only
Time Perspective: Prospective
1 Month
Not Provided
Non-Probability Sample
Adult patients with an indication for wearable defibrillator
  • Myocardial Infarction
  • Ventricular Dysfunction
  • Myocarditis
Not Provided
Not Provided
Not Provided
 
Recruiting
100
March 31, 2018
December 31, 2017   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Adult patients with an indication for wearable defibrillator

Exclusion Criteria:

  • childs
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Yes
Contact: Guido Michels, Prof. Dr. ++49-221-478-32401 guido.michels@uk-koeln.de
Contact: Roman Pfister, Dr. ++49-221-478-32401 roman.pfister@uk-koeln.de
Germany
 
 
NCT02073942
14-050
Not Provided
Not Provided
Not Provided
Guido Michels, University of Cologne
University of Cologne
Zoll Medical Corporation
Not Provided
University of Cologne
October 2017