Cologne Register of Wearable Defibrillator (CRWD)

October 17, 2018 updated by: Guido Michels, University of Cologne

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Germany
- - Cologne, Germany, 50937
    - University of Cologne

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult patients with an indication for wearable defibrillator

Description

Inclusion Criteria:

Adult patients with an indication for wearable defibrillator

Exclusion Criteria:

childs

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of arrhythmic events and arrhythmic risk factors during bridging therapy with wearable defibrillator Time Frame: 3 years	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total mortality Time Frame: 1 months and 3 months	Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	1 months and 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Cologne

Collaborators

Zoll Medical Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2014

Primary Completion (Actual)

December 31, 2017

Study Completion (Actual)

March 31, 2018

Study Registration Dates

First Submitted

February 24, 2014

First Submitted That Met QC Criteria

February 26, 2014

First Posted (Estimate)

February 28, 2014

Study Record Updates

Last Update Posted (Actual)

October 19, 2018

Last Update Submitted That Met QC Criteria

October 17, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

14-050

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.