Atrial Fibrillation/Sinus Rhythm Before and After Cardiov... | NCT01779674

Studies
Atrial Fibrillation/Sinus Rhythm Before and After Cardioversion

NCT01779674

Sponsor

RWTH Aachen University

Status

Completed

Last Update Posted

Jan 8, 2014Estimated

Enrollment

25Actual

Phase

Not provided

Conditions

Atrial Fibrillation

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

Jan 2014

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

Aug 2011

Primary Completion Date

Apr 2012Actual

Completion Date

Apr 2012Actual

First Submitted Date

Jan 28, 2013

First Submission Date that Met QC Criteria

Jan 28, 2013

First Posted Date

Jan 30, 2013Estimated

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

Jan 7, 2014

Last Update Posted Date

Jan 8, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study´s aim is to collect scientific data about patients with atrial inflammation by two principles of sensors measuring congestive heart failure.

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

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

25Actual

Measure	Description	Time Frame
scientific data		1 hour

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients with atrial fibrillation and planned cardioversion
male and female patients aged at least 18 years
patients being able to understand and to follow the study staff´s instructions
signed informed consent

Exclusion Criteria:

persons being hosted in an institution by administrative order or court injunction
pregnancy or breast feeding
persons not being able to consent
persons with implanted electronic devices
material incompatiblity
acute or chronic inflammation of the external or middle ear canal
abnormal anatomic ear canal (congenital or pathological)
persons in a dependent relationship to the investigator or employment contract

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

patients with atrial fibrillation

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Univeristy Hospital Aachen		Aachen	North Rhine Westfalia	52074	Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
26229965	Derived	Zink MD, Bruser C, Winnersbach P, Napp A, Leonhardt S, Marx N, Schauerte P, Mischke K. Heartbeat Cycle Length Detection by a Ballistocardiographic Sensor in Atrial Fibrillation and Sinus Rhythm. Biomed Res Int. 2015;2015:840356. doi: 10.1155/2015/840356. Epub 2015 Jul 1.

ID	Term
D001145	Arrhythmias, Cardiac
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D010335	Pathologic Processes