Cologne Register of Wearable Defibrillator (CRWD) | NCT02073942

Studies
Cologne Register of Wearable Defibrillator (CRWD)

NCT02073942

Sponsor

University of Cologne

Status

Completed

Last Update Posted

Oct 19, 2018Actual

Enrollment

100Actual

Phase

Not provided

Conditions

Myocardial Infarction
Ventricular Dysfunction
Myocarditis

Interventions

Not provided

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2014

Primary Completion Date

Dec 31, 2017Actual

Completion Date

Mar 31, 2018Actual

First Submitted Date

Feb 24, 2014

First Submission Date that Met QC Criteria

Feb 26, 2014

First Posted Date

Feb 28, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 17, 2018

Last Update Posted Date

Oct 19, 2018Actual

Name	Class
Zoll Medical Corporation	INDUSTRY

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Month

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Actual

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adult patients with an indication for wearable defibrillator

Exclusion Criteria:

childs

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Adult patients with an indication for wearable defibrillator

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Cologne		Cologne		50937	Germany

Condition Browse Module

MeSH Terms

ID	Term
D009203	Myocardial Infarction
D018754	Ventricular Dysfunction
D009205	Myocarditis

Ancestor Terms

ID	Term
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D014652	Vascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided