Electrode Positions in Cardioverting Atrial Fibrillation (EPIC)

Comparison of Anterior-Posterior Versus Anterior-Lateral Electrode Position in Cardioverting Atrial Fibrillation - A Randomized Clinical Trial

Atrial fibrillation is the most common heart rhythm disorder, and the incidence is rapidly increasing. Cardioversion using an electrical shock (DC-cardioversion) is an important treatment to reduce symptoms and improve patient's quality-of-life. The treatment is performed by applying gel electrodes to the chest. Cardioversion is not always successful, and it is unknown which electrode-position provides the optimal efficacy.

This study aims to compare two electrode positions, which are in clinical use: Anterior-posterior (left front and left back) versus anterior-lateral (right front and left side of the chest).

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Device: Anterior-posterior electrode position; Device: Anterior-lateral electrode position

• Study Type: Interventional
• Enrollment (Actual): 468
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Horsens, Denmark, 8700
    • Horsens Regional Hospital
  • Randers, Denmark, 8930
    • Randers Regional Hospital
  • Viborg, Denmark, 8800
    • Viborg Regional Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Atrial fibrillation (documented on an ECG-12)
2. Able and willing to sign informed consent
3. Age ≥ 18 years
4. Anticoagulation according to guidelines (Patients with atrial fibrillation for >48 hours will be required to have a documented weekly international normalized ratio (INR) ≥2.0 (including within 48 hours of cardioversion) or treatment with non-vitamin K oral anticoagulant for three weeks or longer. Alternatively, a transoesophageal echocardiogram documenting the absence of intracardiac thrombi is accepted and cardioversion can be performed on treatment with low molecular weight heparin).

Exclusion Criteria:

1. Implanted pacemaker and/or cardioverter defibrillator (ICD)
2. Prior enrollment in the trial
3. Hemodynamically unstable atrial fibrillation
4. Untreated hyperthyroidism
5. Known or suspected pregnancy

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Anterior-posterior electrode position; The anterior electrode is placed in the left parasternal area (precordium). The posterior electrode is placed in the left lower-scapular region with the electrode edge left to the spinal column.	Device: Anterior-posterior electrode position; Escalating energy shocks (100 J, 150 J, 200 J, 360 J) using anterior-posterior electrode position; Other Names: LIFEPAK 20, Physio-Control/Stryker
Active Comparator: Anterior-lateral electrode position; The anterior electrode is placed in the right parasternal area below the clavicle. The lateral electrode is placed with the center of the electrode in the left mid-axillary line in level with the V6 electrocardiogram electrode.	Device: Anterior-lateral electrode position; Escalating energy shocks (100 J, 150 J, 200 J, 360 J) using anterior-lateral electrode position; Other Names: LIFEPAK 20, Physio-Control/Stryker

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy: First shock success	The primary endpoint will be first shock efficacy, i.e. the proportion of patients in sinus rhythm for at least one minute immediately after an initial shock of 100 J.	Immediately after first cardioversion attempt.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy: Successful cardioversion	The secondary efficacy endpoint will be cardioversion success, i.e. the proportion of patients in sinus rhythm for at least one minute after end of protocol.	One minute after cardioversion
Safety: Number of participants with arrhythmic events during and after cardioversion	Secondary safety endpoints will be arrhythmia during and after cardioversion (asystole, transient bradycardia, ventricular arrhythmia, atrioventricular block, recurrence of atrial fibrillation)	Within 2 hours after cardioversion (until discharge)
Safety: Number of participants with skin-discomfort, skin burns or itching	Patient-reported peri-procedural discomfort when asked at discharge.	Two hours after cardioversion (at discharge)

Collaborators and Investigators

• Sponsor: University of Aarhus
• Collaborators: Regionshospitalet Viborg, Skive; Regionshospitalet Horsens; Randers Regional Hospital
• Investigators: Principal Investigator: Anders S Schmidt, MD, Randers Regional Hospital; Study Director: Consultant cardiologist Andi E Albertsen, MD, PhD, Viborg Regional Hospital; Study Chair: Professor Bo Løfgren, MD, PhD, FESC, FAHA, University of Aarhus

Publications and helpful links

General Publications

• Schmidt AS, Lauridsen KG, Moller DS, Christensen PD, Dodt KK, Rickers H, Lofgren B, Albertsen AE. Anterior-Lateral Versus Anterior-Posterior Electrode Position for Cardioverting Atrial Fibrillation. Circulation. 2021 Dec 21;144(25):1995-2003. doi: 10.1161/CIRCULATIONAHA.121.056301. Epub 2021 Nov 24.

Study record dates

Study Major Dates

• Study Start (Actual): February 19, 2019
• Primary Completion (Actual): October 2, 2020
• Study Completion (Actual): October 2, 2020

Study Registration Dates

• First Submitted: January 21, 2019
• First Submitted That Met QC Criteria: January 24, 2019
• First Posted (Actual): January 25, 2019

Study Record Updates

• Last Update Posted (Actual): October 8, 2020
• Last Update Submitted That Met QC Criteria: October 6, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: Cardioversion; Electrode position
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: 66051

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No