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Atrial fibrillation (AF) is a common cardiac arrhythmia that leads to increased risk of heart failure, hospitalization, thromboembolic events, and death. Restoration of normal heart rhythm is performed in many patients with AF to improve symptoms. In this study, the investigators will consider patients who fail 2 or more trials of DC cardioversion as having refractory AF.
The aim of this study is to assess whether the use of double sequential defibrillation in patients with refractory AF has a higher success rate in reverting them to a normal heart rhythm than a third cardioversion.
This is a phase III, randomized controlled, single-centered, superiority trial. All patients with AF admitted to the coronary care unit (CCU) for DC cardioversion, and refractory to at least two trials of DC cardioversion will be enrolled. Patients are randomized into two arms: the first will receive a third trial of DC cardioversion (standard of care) and the second will receive double sequential external defibrillation.
The resolution of AF by reverting back to normal sinus rhythm is the primary outcome of the investigators. This will be determined using EKG (electrocardiogram) immediately after DC cardioversion or double sequential defibrillation.
Patients presenting to the CCU with persistent AF for direct current (DC) cardioversion, who meet the inclusion criteria and fail to revert to normal sinus rhythm after two DC cardioversion attempts will be invited for enrollment in the study. No sampling will be carried out for the sake of this study.
Patients meeting the eligibility criteria will receive double sequential external defibrillation (DSED) or a third DC cardioversion (standard of care).
DSED is the process of using two defibrillators near simultaneously at their highest allowed energy setting and aims to treat refractory atrial fibrillation. The first set of pads is placed in the traditional anterolateral position and the second set can be either placed adjacent to the first set (antero-lateral) or in the antero-posterior position. Shocks are then delivered simultaneously or near simultaneously.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Third trial of DC cardioversion | No Intervention | Patients with atrial fibrillation who fail to revert to sinus rhythm after two failed DC cardioversion attempts will receive a third trial of DC cardioversion (Standard of care) | |
| Double sequential external defibrillation | Experimental | Patients with atrial fibrillation who fail to revert to sinus rhythm after two failed DC cardioversion attempts will receive DSED |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Double sequential external defibrillation | Device | DSED is the process of using two defibrillators near simultaneously at their highest allowed energy setting and aims to treat refractory atrial fibrillation. The first set of pads is placed in the traditional anterolateral position and the second set can be either placed adjacent to the first set (antero-lateral) or in the antero-posterior position. Shocks are then delivered simultaneously or near simultaneously |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with atrial fibrillation who revert back to normal sinus rhythm using Double Sequential External Defibrillation after two failed attempts of DC cardioversion. | Number of participants with atrial fibrillation who revert back to normal sinus rhythm using Double Sequential External Defibrillation after two failed attempts of DC cardioversion . This will be determined using an EKG (Electrocardiogram) immediately after double sequential external defibrillation. | 15 minutes |
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Inclusion Criteria:
- Atrial Fibrillation patients admitted to the CCU for DC cardioversion, and refractory to at least two trials of DC cardioversion
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gilbert Abou Dagher, M.D. | Contact | 00961-1-350000 | 6617 | ga66@aub.edu.lb |
| Marwan Refaat, M.D. | Contact | 00961-1-350000 | 5366 | mr48@aub.edu.lb |
| Name | Affiliation | Role |
|---|---|---|
| Gilbert Abou Dagher, M.D. | American University of Beirut Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| American University of Beirut Medical Center | Recruiting | Beirut | Lebanon |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 9737513 | Background | Benjamin EJ, Wolf PA, D'Agostino RB, Silbershatz H, Kannel WB, Levy D. Impact of atrial fibrillation on the risk of death: the Framingham Heart Study. Circulation. 1998 Sep 8;98(10):946-52. doi: 10.1161/01.cir.98.10.946. | |
| 11216949 | Background | Chugh SS, Blackshear JL, Shen WK, Hammill SC, Gersh BJ. Epidemiology and natural history of atrial fibrillation: clinical implications. J Am Coll Cardiol. 2001 Feb;37(2):371-8. doi: 10.1016/s0735-1097(00)01107-4. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Jan 31, 2019 |
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Phase III, randomized controlled, superiority trial, with two parallel groups, conducted in one academic medical center
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| 24842943 | Background | Patel NJ, Deshmukh A, Pant S, Singh V, Patel N, Arora S, Shah N, Chothani A, Savani GT, Mehta K, Parikh V, Rathod A, Badheka AO, Lafferty J, Kowalski M, Mehta JL, Mitrani RD, Viles-Gonzalez JF, Paydak H. Contemporary trends of hospitalization for atrial fibrillation in the United States, 2000 through 2010: implications for healthcare planning. Circulation. 2014 Jun 10;129(23):2371-9. doi: 10.1161/CIRCULATIONAHA.114.008201. Epub 2014 May 19. |
| 11343485 | Background | Go AS, Hylek EM, Phillips KA, Chang Y, Henault LE, Selby JV, Singer DE. Prevalence of diagnosed atrial fibrillation in adults: national implications for rhythm management and stroke prevention: the AnTicoagulation and Risk Factors in Atrial Fibrillation (ATRIA) Study. JAMA. 2001 May 9;285(18):2370-5. doi: 10.1001/jama.285.18.2370. |
| 16034878 | Background | Mead GE, Elder AT, Flapan AD, Kelman A. Electrical cardioversion for atrial fibrillation and flutter. Cochrane Database Syst Rev. 2005 Jul 20;(3):CD002903. doi: 10.1002/14651858.CD002903.pub2. |
| 1536123 | Background | Alam M, Thorstrand C. Left ventricular function in patients with atrial fibrillation before and after cardioversion. Am J Cardiol. 1992 Mar 1;69(6):694-6. doi: 10.1016/0002-9149(92)90169-y. No abstract available. |
| 7547019 | Background | Xiong C, Sonnhag C, Nylander E, Wranne B. Atrial and ventricular function after cardioversion of atrial fibrillation. Br Heart J. 1995 Sep;74(3):254-60. doi: 10.1136/hrt.74.3.254. |
| 8362771 | Background | Van Gelder IC, Crijns HJ, Blanksma PK, Landsman ML, Posma JL, Van Den Berg MP, Meijler FL, Lie KI. Time course of hemodynamic changes and improvement of exercise tolerance after cardioversion of chronic atrial fibrillation unassociated with cardiac valve disease. Am J Cardiol. 1993 Sep 1;72(7):560-6. doi: 10.1016/0002-9149(93)90352-d. |
| 28017305 | Background | Jaakkola S, Lip GY, Biancari F, Nuotio I, Hartikainen JE, Ylitalo A, Airaksinen KE. Predicting Unsuccessful Electrical Cardioversion for Acute Atrial Fibrillation (from the AF-CVS Score). Am J Cardiol. 2017 Mar 1;119(5):749-752. doi: 10.1016/j.amjcard.2016.11.026. Epub 2016 Dec 2. |
| 1423954 | Background | Levy S, Lauribe P, Dolla E, Kou W, Kadish A, Calkins H, Pagannelli F, Moyal C, Bremondy M, Schork A, et al. A randomized comparison of external and internal cardioversion of chronic atrial fibrillation. Circulation. 1992 Nov;86(5):1415-20. doi: 10.1161/01.cir.86.5.1415. |
| 15655268 | Background | Kabukcu M, Demircioglu F, Yanik E, Minareci K, Ersel-Tuzuner F. Simultaneous double external DC shock technique for refractory atrial fibrillation in concomitant heart disease. Jpn Heart J. 2004 Nov;45(6):929-36. doi: 10.1536/jhj.45.929. |
| 3782643 | Background | Chang MS, Inoue H, Kallok MJ, Zipes DP. Double and triple sequential shocks reduce ventricular defibrillation threshold in dogs with and without myocardial infarction. J Am Coll Cardiol. 1986 Dec;8(6):1393-405. doi: 10.1016/s0735-1097(86)80313-8. |
| 8144780 | Background | Hoch DH, Batsford WP, Greenberg SM, McPherson CM, Rosenfeld LE, Marieb M, Levine JH. Double sequential external shocks for refractory ventricular fibrillation. J Am Coll Cardiol. 1994 Apr;23(5):1141-5. doi: 10.1016/0735-1097(94)90602-5. |
| 15660795 | Background | Alaeddini J, Feng Z, Feghali G, Dufrene S, Davison NH, Abi-Samra FM. Repeated dual external direct cardioversions using two simultaneous 360-J shocks for refractory atrial fibrillation are safe and effective. Pacing Clin Electrophysiol. 2005 Jan;28(1):3-7. doi: 10.1111/j.1540-8159.2005.09155.x. |
| 10588220 | Background | Saliba W, Juratli N, Chung MK, Niebauer MJ, Erdogan O, Trohman R, Wilkoff BL, Augostini R, Mowrey KA, Nadzam GR, Tchou PJ. Higher energy synchronized external direct current cardioversion for refractory atrial fibrillation. J Am Coll Cardiol. 1999 Dec;34(7):2031-4. doi: 10.1016/s0735-1097(99)00463-5. |
| 29730094 | Background | Hajjar K, Berbari I, El Tawil C, Bou Chebl R, Abou Dagher G. Dual defibrillation in patients with refractory ventricular fibrillation. Am J Emerg Med. 2018 Aug;36(8):1474-1479. doi: 10.1016/j.ajem.2018.04.060. Epub 2018 Apr 30. |
| Jan 31, 2019 |
| Prot_SAP_ICF_000.pdf |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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