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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
  Purpose
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
Myocardial Infarction Ventricular Dysfunction Myocarditis

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 Guido Michels, 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: March 31, 2018
Estimated Primary Completion Date: December 31, 2017 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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
Criteria

Inclusion Criteria:

  • Adult patients with an indication for wearable defibrillator

Exclusion Criteria:

  • childs
  Contacts and Locations
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


Contacts
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

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

Responsible Party: Guido Michels, PD Dr., University of Cologne
ClinicalTrials.gov Identifier: NCT02073942     History of Changes
Other Study ID Numbers: 14-050
First Submitted: February 24, 2014
First Posted: February 28, 2014
Last Update Posted: October 26, 2017
Last Verified: October 2017

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