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

January 31, 2019 updated by: American University of Beirut Medical Center

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.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Gilbert Abou Dagher, M.D.
  • Phone Number: 6617 00961-1-350000
  • Email: ga66@aub.edu.lb

Study Contact Backup

  • Name: Marwan Refaat, M.D.
  • Phone Number: 5366 00961-1-350000
  • Email: mr48@aub.edu.lb

Study Locations

  • Lebanon
      • Beirut, Lebanon
        • Recruiting
        • American University of Beirut Medical Center
        • Contact:
          • Gilbert Abou Dagher, M.D.
          • Phone Number: 6617 00961-1-350000
          • Email: ga66@aub.edu.lb

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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.
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.
15 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

American University of Beirut Medical Center

Investigators

  • Principal Investigator: Gilbert Abou Dagher, M.D., American University of Beirut Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 21, 2019

Primary Completion (Anticipated)

January 21, 2024

Study Completion (Anticipated)

January 21, 2024

Study Registration Dates

First Submitted

January 28, 2019

First Submitted That Met QC Criteria

January 31, 2019

First Posted (Actual)

February 4, 2019

Study Record Updates

Last Update Posted (Actual)

February 4, 2019

Last Update Submitted That Met QC Criteria

January 31, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BIO-2017-0457

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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