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Statistical interim analysis showed valid and significant results
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AP Position | Active Comparator | Cardioversion with antero-posterior electrode position |
|
| AL Position | Active Comparator | Cardioversion with antero-lateral electrode position |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| external electrical cardioversion (with antero-posterior electrode position) | Procedure | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 30 seconds after cardioversion |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Number of Cardioversion Shocks | 30 seconds after cardioversion | |
| Mean Energy Requirement for Successful Cardioversion | Overall energy in the mean (number of joules) necessary for successful cardioversion of all patients per group. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stephan Willems, Prof. Dr. | Oberarzt | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Hamburg-Eppendorf, Heart Center | Hamburg | 20246 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 6733884 | Background | Kerber RE, Kouba C, Martins J, Kelly K, Low R, Hoyt R, Ferguson D, Bailey L, Bennett P, Charbonnier F. Advance prediction of transthoracic impedance in human defibrillation and cardioversion: importance of impedance in determining the success of low-energy shocks. Circulation. 1984 Aug;70(2):303-8. doi: 10.1161/01.cir.70.2.303. | |
| 12414201 |
| Label | URL |
|---|---|
| Homepage of University Hospital Hamburg-Eppendorf | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Antero-Posterior Group | Cardioversion with antero-posterior electrode position |
| FG001 | Antero-Lateral Group | Cardioversion with antero-lateral electrode position |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| external electrical cardioversion (with antero-lateral electrode position) | Procedure | 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 |
|
|
| 30 seconds after cardioversion |
| 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. | 30 seconds after cardioversion |
| Kirchhof P, Eckardt L, Loh P, Weber K, Fischer RJ, Seidl KH, Bocker D, Breithardt G, Haverkamp W, Borggrefe M. Anterior-posterior versus anterior-lateral electrode positions for external cardioversion of atrial fibrillation: a randomised trial. Lancet. 2002 Oct 26;360(9342):1275-9. doi: 10.1016/s0140-6736(02)11315-8. |
| 14739731 | Background | Kirchhof P, Borggrefe M, Breithardt G. Effect of electrode position on the outcome of cardioversion. Card Electrophysiol Rev. 2003 Sep;7(3):292-6. doi: 10.1023/B:CEPR.0000012399.96959.ab. |
| 7266602 | Background | Kerber RE, Jensen SR, Grayzel J, Kennedy J, Hoyt R. Elective cardioversion: influence of paddle-electrode location and size on success rates and energy requirements. N Engl J Med. 1981 Sep 17;305(12):658-62. doi: 10.1056/NEJM198109173051202. |
| 10573502 | Background | Botto GL, Politi A, Bonini W, Broffoni T, Bonatti R. External cardioversion of atrial fibrillation: role of paddle position on technical efficacy and energy requirements. Heart. 1999 Dec;82(6):726-30. doi: 10.1136/hrt.82.6.726. |
| 14560770 | Background | Yoon RS, DeMonte TP, Hasanov KF, Jorgenson DB, Joy ML. Measurement of thoracic current flow in pigs for the study of defibrillation and cardioversion. IEEE Trans Biomed Eng. 2003 Oct;50(10):1167-73. doi: 10.1109/TBME.2003.816082. |
| 10568674 | Background | Van Gelder IC, Tuinenburg AE, Schoonderwoerd BS, Tieleman RG, Crijns HJ. Pharmacologic versus direct-current electrical cardioversion of atrial flutter and fibrillation. Am J Cardiol. 1999 Nov 4;84(9A):147R-151R. doi: 10.1016/s0002-9149(99)00715-8. |
| 8903272 | Background | Kerber RE. Transthoracic cardioversion of atrial fibrillation and flutter: standard techniques and new advances. Am J Cardiol. 1996 Oct 17;78(8A):22-6. doi: 10.1016/s0002-9149(96)00562-0. |
| 7790013 | Background | Camacho MA, Lehr JL, Eisenberg SR. A three-dimensional finite element model of human transthoracic defibrillation: paddle placement and size. IEEE Trans Biomed Eng. 1995 Jun;42(6):572-8. doi: 10.1109/10.387196. |
| 15734772 | Background | Kirchhof P, Monnig G, Wasmer K, Heinecke A, Breithardt G, Eckardt L, Bocker D. A trial of self-adhesive patch electrodes and hand-held paddle electrodes for external cardioversion of atrial fibrillation (MOBIPAPA). Eur Heart J. 2005 Jul;26(13):1292-7. doi: 10.1093/eurheartj/ehi160. Epub 2005 Feb 25. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Antero-Posterior Group | Cardioversion with antero-posterior electrode position |
| BG001 | Antero-Lateral Group | Cardioversion with antero-lateral electrode position |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Mean Number of Cardioversion Shocks | Posted | Mean | Standard Deviation | Shocks | 30 seconds after cardioversion |
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| ||||||||||||||||||||||||||||||
| 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. | Posted | Number | participants | 30 seconds after cardioversion |
|
| |||||||||||||||||||||||||||||||
| Secondary | Mean Energy Requirement for Successful Cardioversion | Overall energy in the mean (number of joules) necessary for successful cardioversion of all patients per group. | Posted | Mean | Standard Deviation | Joules | 30 seconds after cardioversion |
|
| ||||||||||||||||||||||||||||||
| 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. | Posted | Number | participants | 30 seconds after cardioversion |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Antero-Posterior Group | Cardioversion with antero-posterior electrode position | 0 | 48 | 0 | 48 | ||
| EG001 | Antero-Lateral Group | Cardioversion with antero-lateral electrode position | 0 | 48 | 0 | 48 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tim Risius, MD | University Hospital Hamburg-Eppendorf, Heart Center | +49-40-42803 | 4142 | risius@uke.uni-hamburg.de |
| ID | Term |
|---|---|
| D001282 | Atrial Flutter |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| >=65 years |
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| Male |
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