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
  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 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 ]

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)
  Eligibility

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

Criteria

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 ClinicalTrials.gov identifier: NCT02073942

Contacts
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

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

No publications provided

Responsible Party: Guido Michels, PD Dr., University of Cologne
ClinicalTrials.gov Identifier: NCT02073942     History of Changes
Other Study ID Numbers: 14-050
Study First Received: February 24, 2014
Last Updated: February 26, 2014
Health Authority: Germany: Ethics Commission

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

ClinicalTrials.gov processed this record on September 30, 2014