Double Sequential External Defibrillation in Patients With Atrial Fibrillation Refractory to DC Cardioversion

Atrial Fibrillation Clinical Trial

Official title:

Double Sequence External Defibrillation: A Randomized Controlled Trial in Patients With Atrial Fibrillation Refractory to DC Cardioversion

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03827915
• Other study ID #: BIO-2017-0457
• Status: Recruiting
• Phase: N/A
• Start date: January 21, 2019
• Est. completion date: January 21, 2024

Study information

• Verified date: January 2019
• Source: American University of Beirut Medical Center
• Contact: Gilbert Abou Dagher, M.D.
• Phone: 00961-1-350000
• Email: ga66[@]aub.edu.lb
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: January 21, 2024
• Est. primary completion date: January 21, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Atrial Fibrillation patients admitted to the CCU for DC cardioversion, and refractory to at least two trials of DC cardioversion

Exclusion Criteria:

• Patients with Atrial Fibrillation not requiring DC cardioversion

• Patients with Atrial Fibrillation who reverted after a maximum of two trials of DC cardioversion

Related Conditions & MeSH terms

• Atrial Fibrillation
• Defibrillators
• Persistent Atrial Fibrillation

Intervention

Device:
• Double sequential external defibrillation
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

Locations

Country	Name	City	State
Lebanon	American University of Beirut Medical Center	Beirut

Sponsors (1)

Lead Sponsor	Collaborator
American University of Beirut Medical Center

Country where clinical trial is conducted

Lebanon, 

References & Publications (16)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

Kabukcu M, Demircioglu F, Yanik E, Minareci K, Ersel-Tüzüner F. Simultaneous double external DC shock technique for refractory atrial fibrillation in concomitant heart disease. Jpn Heart J. 2004 Nov;45(6):929-36. — View Citation

Lévy 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. — View Citation

Mead GE, Elder AT, Flapan AD, Kelman A. Electrical cardioversion for atrial fibrillation and flutter. Cochrane Database Syst Rev. 2005 Jul 20;(3):CD002903. Review. Update in: Cochrane Database Syst Rev. 2017 Nov 15;11:CD002903. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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