NCT01678456

Brief Summary

Prospective registration and independent assessment of SAE associated with atrial fibrillation such as thromboembolic events, and other cardiac and noncardiac complications by a Critical Event Committee.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
13,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2004

Longer than P75 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

February 1, 2004

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

September 14, 2005

Completed
7 years until next milestone

First Posted

Study publicly available on registry

September 5, 2012

Completed
26 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

September 22, 2020

Status Verified

August 1, 2012

Enrollment Period

8.7 years

First QC Date

September 14, 2005

Last Update Submit

September 18, 2020

Conditions

Atrial FibrillationAssessment of Serious Advers EventsThromboembolic and Bleeding ComplicationsComplications of Antiarrhythmic Drugs or Invasive ProceduresAssessment by a Critical Event Committee

Keywords

Atrial FibrillationCritical Event CommitteeSerious adverse eventsThromboembolic complicationsCardiac and noncardiac complicationsBleeding complicationsAcute heart failureSyncopeResuscitation

Eligibility Criteria

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

Real-life population Patients with atrial fibrilation documented within the last 12 months before enrollment

You may qualify if:

  • Atrial fibrillation documented by ECG not older then one year
  • Age \> 18 years
  • Informed consent

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Staedt. Klinikum, Department of Cardiology

Brandenburg, 14770, Germany

Location

MeSH Terms

Conditions

Atrial FibrillationSyncope

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsUnconsciousnessConsciousness DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and Symptoms

Study Officials

  • Michael Oeff, Professor

    SAE-Zentrum Brandenburg/Havel Germany

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

September 14, 2005

First Posted

September 5, 2012

Study Start

February 1, 2004

Primary Completion

October 1, 2012

Study Completion

December 1, 2012

Last Updated

September 22, 2020

Record last verified: 2012-08

Locations

DE(1)