Atrial Fibrillation/Sinus Rhythm Before and After Cardioversion

Atrial Fibrillation Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01779674
• Other study ID #: 10-079
• Status: Completed
• Phase: N/A
• First received: January 28, 2013
• Last updated: January 7, 2014
• Start date: August 2011
• Est. completion date: April 2012

Study information

• Verified date: January 2014
• Source: RWTH Aachen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medicianl Devices
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Atrial Fibrillation

Locations

Country	Name	City	State
Germany	Univeristy Hospital Aachen	Aachen	North Rhine Westfalia

Sponsors (1)

Lead Sponsor	Collaborator
RWTH Aachen University

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	scientific data		1 hour	No