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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03827915
Recruitment Status : Recruiting
First Posted : February 4, 2019
Last Update Posted : February 4, 2019
Sponsor:
Information provided by (Responsible Party):
American University of Beirut Medical Center

Brief 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.


Condition or disease Intervention/treatment Phase
Atrial Fibrillation Defibrillators Persistent Atrial Fibrillation Device: Double sequential external defibrillation Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Phase III, randomized controlled, superiority trial, with two parallel groups, conducted in one academic medical center
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Double Sequence External Defibrillation: A Randomized Controlled Trial in Patients With Atrial Fibrillation Refractory to DC Cardioversion
Actual Study Start Date : January 21, 2019
Estimated Primary Completion Date : January 21, 2024
Estimated Study Completion Date : January 21, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Third trial of DC cardioversion
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)
Experimental: Double sequential external defibrillation
Patients with atrial fibrillation who fail to revert to sinus rhythm after two failed DC cardioversion attempts will receive DSED
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




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03827915


Contacts
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Contact: Gilbert Abou Dagher, M.D. 00961-1-350000 ext 6617 ga66@aub.edu.lb
Contact: Marwan Refaat, M.D. 00961-1-350000 ext 5366 mr48@aub.edu.lb

Locations
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Lebanon
American University of Beirut Medical Center Recruiting
Beirut, Lebanon
Contact: Gilbert Abou Dagher, M.D.    00961-1-350000 ext 6617    ga66@aub.edu.lb   
Sponsors and Collaborators
American University of Beirut Medical Center
Investigators
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Principal Investigator: Gilbert Abou Dagher, M.D. American University of Beirut Medical Center
  Study Documents (Full-Text)

Documents provided by American University of Beirut Medical Center:
Publications:

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Responsible Party: American University of Beirut Medical Center
ClinicalTrials.gov Identifier: NCT03827915    
Other Study ID Numbers: BIO-2017-0457
First Posted: February 4, 2019    Key Record Dates
Last Update Posted: February 4, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by American University of Beirut Medical Center:
Atrial fibrillation
Refractory atrial fibrillation
Double sequential external defibrillation
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes