Atrial FibrillationNCT03827915
Double Sequential External Defibrillation in Patients With Atrial Fibrillation Refractory to DC Cardioversion
A study testing Double sequential external defibrillation in people with Atrial Fibrillation and Defibrillators, run by American University of Beirut Medical Center at 1 site in Lebanon.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Atrial Fibrillation, Defibrillators, Persistent Atrial Fibrillation
- What is being tested?
- Double sequential external defibrillation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteLebanon
- Study dates
- 21 Jan 2019to 21 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Atrial Fibrillation patients admitted to the CCU for DC cardioversion, and refractory to at least two trials of DC cardioversion
Who cannot join
- Patients with Atrial Fibrillation not requiring DC cardioversion
- Patients with Atrial Fibrillation who reverted after a maximum of two trials of DC cardioversion
Trial locations and contacts
1 site in 1 country.
Lebanon1 site, 1 recruiting
- Recruiting
American University of Beirut Medical Center
Beirut
Gilbert Abou Dagher, M.D., 00961-1-350000 ext. 6617, ga66@aub.edu.lb
About this study
Official title: Double Sequence External Defibrillation: A Randomized Controlled Trial in Patients With Atrial Fibrillation Refractory to DC Cardioversion
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.
Read more
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.
Read the detailed 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.
- Being tested
- Double sequential external defibrillation
- Keywords
- Atrial fibrillation, Refractory atrial fibrillation, Double sequential external defibrillation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Double sequential external defibrillationDevice
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: Double sequential external defibrillation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2019
- Study start21 Jan 2019
- Primary completion21 Jan 2024 (estimated)
- Study completion21 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Phase III, randomized controlled, superiority trial, with two parallel groups, conducted in one academic medical center
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- American University of Beirut Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gilbert Abou Dagher, M.D., Principal investigator, American University of Beirut Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03827915
- Sponsor's protocol ID
- BIO-2017-0457
- Status last verified
- Jan 2019
- First submitted
- 28 Jan 2019
- Last updated
- 4 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 9737513Chugh 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.
PubMed 11216949Patel 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.
PubMed 24842943Go 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.
PubMed 11343485Mead 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.
PubMed 16034878Alam 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.
PubMed 1536123Xiong 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.
PubMed 7547019Van 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.
PubMed 8362771Jaakkola 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.
PubMed 28017305Levy 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.
PubMed 1423954Kabukcu 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.
PubMed 15655268Chang 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.
PubMed 3782643Hoch 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.
PubMed 8144780Alaeddini 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.
PubMed 15660795Saliba 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.
PubMed 10588220
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double Sequence External Defibrillation: A Randomized Controlled Trial in Patients With Atrial Fibrillation Refractory to DC Cardioversion
- ClinicalTrials.gov ID
- NCT03827915
- Acronym / sponsor ID
- BIO-2017-0457
- Keywords
- Atrial fibrillation, Refractory atrial fibrillation, Double sequential external defibrillation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- American University of Beirut Medical CenterUniversity, hospital or other
- Study start
- 21 Jan 2019 (actual)
- Primary completion
- 21 Jan 2024 (estimated)
- Study completion
- 21 Jan 2024 (estimated)
- First posted
- 4 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Phase III, randomized controlled, superiority trial, with two parallel groups, conducted in one academic medical center
| Arm | Type | Receives |
|---|---|---|
| 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 | Device: Double sequential external defibrillationPatients with atrial fibrillation who fail to revert to sinus rhythm after two failed DC cardioversion attempts will receive DSED |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Atrial Fibrillation patients admitted to the CCU for DC cardioversion, and refractory to at least two trials of DC cardioversion
Key exclusion criteria (2 listed)
- Patients with Atrial Fibrillation not requiring DC cardioversion
- Patients with Atrial Fibrillation who reverted after a maximum of two trials of DC cardioversion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Double sequential external defibrillationDSED 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 | Device | Double sequential external defibrillation |
Primary outcome
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.
Time frame: 15 minutes
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2019.
- Background: PubMed 9737513Benjamin 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.
- Background: PubMed 11216949Chugh 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.
- Background: PubMed 24842943Patel 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.
- Background: PubMed 11343485Go 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.
- Background: PubMed 16034878Mead 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.
- Background: PubMed 1536123Alam 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.
- Background: PubMed 7547019Xiong 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.
- Background: PubMed 8362771Van 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.
- Background: PubMed 28017305Jaakkola 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.
- Background: PubMed 1423954Levy 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.
- Background: PubMed 15655268Kabukcu 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.
- Background: PubMed 3782643Chang 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gilbert Abou Dagher, M.D. principal investigator
American University of Beirut Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Double sequential external defibrillation in people with Atrial Fibrillation and Defibrillators, run by American University of Beirut Medical Center at 1 site in Lebanon.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Lebanon. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gilbert Abou Dagher, M.D. (00961-1-350000 ext. 6617, ga66@aub.edu.lb), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 15 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03827915, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2019.