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Clinical Trials/NCT00860314
NCT00860314TerminatedNot Applicable

Prospective, Randomized Single-center Study for Efficacy of Antero-posterior and Antero-lateral Electrode Position for External Electrical Cardioversion of Typical Atrial Flutter

Universitätsklinikum Hamburg-Eppendorf1 site in 1 country96 target enrollmentStarted: January 1, 2005Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Terminated
Enrollment
96
Locations
1
Primary Endpoint
Number of Successfully Cardioverted Participants for Each Electrode Position

Study Overview

Brief Summary

The aim of this study is to identify the one electrode position out of two most commonly used for external electrical cardioversion of typical atrial flutter, which needs less delivered energy and less needed number of shocks for successful cardioversion.

Detailed Description

Typical atrial flutter is the second-most prevalent atrial tachyarrhythmia. No guidelines for treatment exist and few studies investigate treatment of atrial flutter. Mostly, guidelines for atrial fibrillation are followed for treatment of atrial flutter. Atrial flutter has a different pathomechanism as atrial fibrillation, therefore special guidelines for treatment are needed. Among drug treatment and ablation procedures, external electrical cardioversion is commonly used, especially for treatment of acute symptomatic patients. This study may help to further define safe and successful procedures for electrical cardioversion of atrial flutter.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •clinical diagnosis of typical atrial flutter
  • •signed written informed consent
  • •eligibility for sedation and external electrical cardioversion

Exclusion Criteria

  • •clinical diagnosis of arrhythmia other than typical atrial flutter
  • •implanted ICD or pacemaker
  • •proof of atrial thrombi

Arms & Interventions

AP Position

Active Comparator

Cardioversion with antero-posterior electrode position

Intervention: external electrical cardioversion (with antero-posterior electrode position) (Procedure)

AL Position

Active Comparator

Cardioversion with antero-lateral electrode position

Intervention: external electrical cardioversion (with antero-lateral electrode position) (Procedure)

Outcomes

Primary Outcomes

Number of Successfully Cardioverted Participants for Each Electrode Position

Time Frame: 30 seconds after cardioversion

After restoration of normal sinus rhythm for 30 seconds and longer by electrical countershock a cardioversion is counted as successful.

Secondary Outcomes

  • Number of Participants Succesfully Cardioverted With First Shock in Each Electrode Position(30 seconds after cardioversion)
  • Mean Number of Cardioversion Shocks(30 seconds after cardioversion)
  • Mean Energy Requirement for Successful Cardioversion(30 seconds after cardioversion)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Prof. Dr. Stephan Willems

Ltd. Oberarzt des Universitären Herzzentrums Hamburg

Universitätsklinikum Hamburg-Eppendorf

Study Sites (1)

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