NCT01779674

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2011

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2011

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

January 28, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 30, 2013

Completed
Last Updated

January 8, 2014

Status Verified

January 1, 2014

Enrollment Period

8 months

First QC Date

January 28, 2013

Last Update Submit

January 7, 2014

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

  • scientific data

    1 hour

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients with atrial fibrillation

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Univeristy Hospital Aachen

Aachen, North Rhine Westfalia, 52074, Germany

Location

Related Publications (1)

  • 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.

    PMID: 26229965DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 28, 2013

First Posted

January 30, 2013

Study Start

August 1, 2011

Primary Completion

April 1, 2012

Study Completion

April 1, 2012

Last Updated

January 8, 2014

Record last verified: 2014-01

Locations

DE(1)