Cologne Register of Wearable Defibrillator (CRWD)

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2015 by University of Cologne
Zoll Medical Corporation
Information provided by (Responsible Party):
Guido Michels, University of Cologne Identifier:
First received: February 24, 2014
Last updated: December 10, 2015
Last verified: December 2015
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.

Myocardial Infarction
Ventricular Dysfunction

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 1 Month

Resource links provided by NLM:

Further study details as provided by University of Cologne:

Primary Outcome Measures:
  • Number of arrhythmic events and arrhythmic risk factors during bridging therapy with wearable defibrillator [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Total mortality [ Time Frame: 1 months and 3 months ] [ Designated as safety issue: Yes ]
  • Quality of life [ Time Frame: 1 months and 3 months ] [ Designated as safety issue: Yes ]
    SF-12v2® Health Survey questionnaire

  • Depression [ Time Frame: 1 months and 3 months ] [ Designated as safety issue: Yes ]
    BDI-II questionnaire

  • Anxiety [ Time Frame: 1 months and 3 months ] [ Designated as safety issue: Yes ]
    STAI-G Form X1 questionnaire

Estimated Enrollment: 100
Study Start Date: February 2014
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: March 2017 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Adult patients with an indication for wearable defibrillator

Inclusion Criteria:

  • Adult patients with an indication for wearable defibrillator

Exclusion Criteria:

  • childs
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT02073942

Contact: Guido Michels, Prof. Dr. ++49-221-478-32401
Contact: Roman Pfister, Dr. ++49-221-478-32401

University of Cologne Recruiting
Cologne, Germany, 50937
Contact: Guido Michels, Prof. Dr.    ++49-221-478-32401   
Contact: Roman Pfister, Dr.    ++49-221-478-32401   
Sponsors and Collaborators
University of Cologne
Zoll Medical Corporation
  More Information

Responsible Party: Guido Michels, PD Dr., University of Cologne Identifier: NCT02073942     History of Changes
Other Study ID Numbers: 14-050 
Study First Received: February 24, 2014
Last Updated: December 10, 2015
Health Authority: Germany: Ethics Commission

Additional relevant MeSH terms:
Myocardial Infarction
Ventricular Dysfunction
Cardiovascular Diseases
Heart Diseases
Myocardial Ischemia
Vascular Diseases processed this record on May 26, 2016