NCT00369330

Brief Summary

To investigate if in acute symptomatic atrial fibrillation (AF) the early (\>2 hrs but within 12 hrs of the beginning of the arrhythmia) electrical cardioversion leads to a longer recurrence-free interval than the delayed cardioversion (\> 36 hrs but \< 48 hrs after the beginning of the arrhythmia) within the first 3 months after cardioversion.

Trial Health

35
At Risk

Trial Health Score

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

Geographic Reach
1 country

1 active site

Status
withdrawn

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 28, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 29, 2006

Completed
3 days until next milestone

Study Start

First participant enrolled

September 1, 2006

Completed
Last Updated

September 3, 2012

Status Verified

August 1, 2006

First QC Date

August 28, 2006

Last Update Submit

August 31, 2012

Conditions

Atrial Fibrillation

Keywords

atrial fibrillationearly cardioversionelectrical cardioversion

Outcome Measures

Secondary Outcomes (6)

  • Number of electrical cardioversion because of AF

  • Need to initiate or change medical antiarrhythmic treatment because of recurrence of AF

  • Number and length of stay of hospitalization because of cardiovascular reasons

  • Number of thromboembolic events

  • Number of therapy non-responder and early recurrence of AF

  • +1 more secondary outcomes

Interventions

external electrical cardioversionDEVICE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • documented AF that began between 2 and 8 hrs before randomization
  • indication for electrical cardioversion.
  • age above 18 yrs
  • written informed consent

You may not qualify if:

  • AF caused by not adequately treated reversible conditions(e.g. myocardial infarction, thyrotoxicosis, ethanol intoxication, infection, pericarditis, surgery)
  • newly initiated (i.e. within 7 days before randomization) antiarrhythmic agents of class I, II and/or III
  • catheter ablation of AF within 3 months before randomization
  • pacemaker or icd
  • myocardial infarction within 3 months before randomization
  • urgent need to cardioversion of AF because of associated potentially dangerous symptoms such as chest pain, syncope, dyspnea
  • contraindications for therapy with vitamin k-antagonists
  • intracardial thrombus
  • primary indication for pharmacological cardioversion
  • in females: pregnancy, lactation period or no sufficient contraception within last 3 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medizinische Klinik und Poliklinik II, University Hospital of Bonn

Bonn, 53105, Germany

Location

Related Links

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Thorsten Lewalter, MD

    Medizinische Klinik und Poliklinik II - Universitätsklinikum Bonn, Bonn, Germany

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 28, 2006

First Posted

August 29, 2006

Study Start

September 1, 2006

Last Updated

September 3, 2012

Record last verified: 2006-08

Locations

DE(1)