Cologne Register of Wearable Defibrillator (CRWD)

Myocardial Infarction Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02073942
• Other study ID #: 14-050
• Status: Completed
• Start date: February 2014
• Est. completion date: March 31, 2018

Study information

• Verified date: October 2018
• Source: University of Cologne
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: March 31, 2018
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult patients with an indication for wearable defibrillator

Exclusion Criteria:

• childs

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction
• Myocarditis
• Ventricular Dysfunction

Locations

Country	Name	City	State
Germany	University of Cologne	Cologne

Sponsors (2)

Lead Sponsor	Collaborator
University of Cologne	Zoll Medical Corporation

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of arrhythmic events and arrhythmic risk factors during bridging therapy with wearable defibrillator		3 years
Secondary	Total mortality	Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	1 months and 3 months