Atrial Fibrillation/Sinus Rhythm Before and After Cardioversion

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
RWTH Aachen University
ClinicalTrials.gov Identifier:
NCT01779674
First received: January 28, 2013
Last updated: January 7, 2014
Last verified: January 2014
  Purpose

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


Condition
Atrial Fibrillation

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by RWTH Aachen University:

Primary Outcome Measures:
  • scientific data [ Time Frame: 1 hour ] [ Designated as safety issue: No ]

Enrollment: 25
Study Start Date: August 2011
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

patients with atrial fibrillation

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01779674

Locations
Germany
Univeristy Hospital Aachen
Aachen, North Rhine Westfalia, Germany, 52074
Sponsors and Collaborators
RWTH Aachen University
  More Information

No publications provided

Responsible Party: RWTH Aachen University
ClinicalTrials.gov Identifier: NCT01779674     History of Changes
Other Study ID Numbers: 10-079
Study First Received: January 28, 2013
Last Updated: January 7, 2014
Health Authority: Germany: Federal Institute for Drugs and Medicianl Devices

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on July 31, 2014