Atrial Flutter
Conditions
Keywords
external electrical cardioversion, typical atrial flutter, electrode position, antero-lateral, antero-posterior, biphasic cardioversion, step-up protocol
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.
Interventions
PROCEDUREexternal electrical cardioversion (with antero-posterior electrode position)
external biphasic electrical cardioversion with step-up-protocol of 50-75-100-150-200 Joules if necessary with antero-posterior electrode position until restoration of normal sinus rhythm
PROCEDUREexternal electrical cardioversion (with antero-lateral electrode position)
external biphasic electrical cardioversion with step-up protocol of 50-75-100-150-200 Joules if necessary with antero-lateral electrode position until restoration of normal sinus rhythm
Sponsors
Universitätsklinikum Hamburg-Eppendorf
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Successfully Cardioverted Participants for Each Electrode Position | 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
| Measure | Time frame | Description |
|---|---|---|
| Mean Number of Cardioversion Shocks | 30 seconds after cardioversion | — |
| Mean Energy Requirement for Successful Cardioversion | 30 seconds after cardioversion | Overall energy in the mean (number of joules) necessary for successful cardioversion of all patients per group. |
| Number of Participants Succesfully Cardioverted With First Shock in Each Electrode Position | 30 seconds after cardioversion | Number of participants successfully cardioverted to normal sinus rhythm with one shock of 50 Joules. |
Countries
Germany
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Antero-Posterior Group Cardioversion with antero-posterior electrode position | 48 |
| Antero-Lateral Group Cardioversion with antero-lateral electrode position | 48 |
| Total | 96 |
Baseline characteristics
| Characteristic | Antero-Lateral Group | Antero-Posterior Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 17 Participants | 21 Participants | 38 Participants |
| Age, Categorical Between 18 and 65 years | 31 Participants | 27 Participants | 58 Participants |
| Age, Continuous | 62 years STANDARD_DEVIATION 12.53 | 62 years STANDARD_DEVIATION 12.18 | 62 years STANDARD_DEVIATION 12.29 |
| Region of Enrollment Germany | 48 participants | 48 participants | 96 participants |
| Sex: Female, Male Female | 13 Participants | 11 Participants | 24 Participants |
| Sex: Female, Male Male | 35 Participants | 37 Participants | 72 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 48 | 0 / 48 |
| serious Total, serious adverse events | 0 / 48 | 0 / 48 |
Outcome results
Primary
Number of Successfully Cardioverted Participants for Each Electrode Position
After restoration of normal sinus rhythm for 30 seconds and longer by electrical countershock a cardioversion is counted as successful.
Time frame: 30 seconds after cardioversion
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Antero-Posterior Group | Number of Successfully Cardioverted Participants for Each Electrode Position | 48 participants |
| Antero-Lateral Group | Number of Successfully Cardioverted Participants for Each Electrode Position | 48 participants |
Secondary
Mean Energy Requirement for Successful Cardioversion
Overall energy in the mean (number of joules) necessary for successful cardioversion of all patients per group.
Time frame: 30 seconds after cardioversion
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Antero-Posterior Group | Mean Energy Requirement for Successful Cardioversion | 77 Joules | Standard Deviation 13 |
| Antero-Lateral Group | Mean Energy Requirement for Successful Cardioversion | 65 Joules | Standard Deviation 13 |
Secondary
Mean Number of Cardioversion Shocks
Time frame: 30 seconds after cardioversion
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Antero-Posterior Group | Mean Number of Cardioversion Shocks | 1.96 Shocks | Standard Deviation 1 |
| Antero-Lateral Group | Mean Number of Cardioversion Shocks | 1.48 Shocks | Standard Deviation 1.01 |
Secondary
Number of Participants Succesfully Cardioverted With First Shock in Each Electrode Position
Number of participants successfully cardioverted to normal sinus rhythm with one shock of 50 Joules.
Time frame: 30 seconds after cardioversion
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Antero-Posterior Group | Number of Participants Succesfully Cardioverted With First Shock in Each Electrode Position | 17 participants |
| Antero-Lateral Group | Number of Participants Succesfully Cardioverted With First Shock in Each Electrode Position | 35 participants |