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Cologne Register of Wearable Defibrillator (CRWD)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2017 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: May 1, 2017
Last verified: May 2017
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 ]

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 100
Study Start Date: February 2014
Estimated Study Completion Date: July 31, 2017
Primary Completion Date: March 31, 2017 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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: May 1, 2017

Additional relevant MeSH terms:
Myocardial Infarction
Ventricular Dysfunction
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Cardiomyopathies processed this record on May 25, 2017