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

NCT03827915 | Unknown DMC

• 1 other identifier: BIO-2017-0457
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation; Defibrillators; Persistent Atrial Fibrillation

Keywords

Atrial fibrillation; Refractory atrial fibrillation; Double sequential external defibrillation

Outcome Measures

Primary Outcomes (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.

  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

Study Arms (2)

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

Device: Double sequential external defibrillation

Interventions

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

Double sequential external defibrillation

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Patients with Atrial Fibrillation not requiring DC cardioversion
• Patients with Atrial Fibrillation who reverted after a maximum of two trials of DC cardioversion

Sponsors & Collaborators

• American University of Beirut Medical Center: lead

Study Sites (1)

American University of Beirut Medical Center

Beirut, Lebanon

RECRUITING

Related Publications (16)

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  PMID: 28017305 BACKGROUND

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• 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.

  PMID: 29730094 BACKGROUND

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Gilbert Abou Dagher, M.D.

  American University of Beirut Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gilbert Abou Dagher, M.D.

CONTACT

00961-1-350000; ga66@aub.edu.lb

Marwan Refaat, M.D.

CONTACT

00961-1-350000; mr48@aub.edu.lb

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Phase III, randomized controlled, superiority trial, with two parallel groups, conducted in one academic medical center

Study Record Dates

• First Submitted: January 28, 2019
• First Posted: February 4, 2019
• Study Start: January 21, 2019
• Primary Completion: January 21, 2024
• Study Completion: January 21, 2024
• Last Updated: February 4, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

LE (1)