Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Cologne Register of Wearable Defibrillator (CRWD)

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by University of Cologne
Sponsor:
Collaborator:
Zoll Medical Corporation
Information provided by (Responsible Party):
Guido Michels, University of Cologne
ClinicalTrials.gov Identifier:
NCT02073942
First received: February 24, 2014
Last updated: February 26, 2014
Last verified: February 2014

February 24, 2014
February 26, 2014
February 2014
March 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 ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: Yes ]
Same as current
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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
December 2017
March 2017   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Adult patients with an indication for wearable defibrillator

Exclusion Criteria:

  • childs
Both
18 Years and older
Yes
Contact: Guido Michels, 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
Guido Michels, University of Cologne
University of Cologne
Zoll Medical Corporation
Not Provided
University of Cologne
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP