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Completed

NCT Number: NCT03817372

Electrode Positions in Cardioverting Atrial Fibrillation

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).

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Horsens Regional Hospital, Horsens, Denmark

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Atrial fibrillation (documented on an ECG-12)
  • Able and willing to sign informed consent
  • Age ≥ 18 years
  • 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

  • Implanted pacemaker and/or cardioverter defibrillator (ICD)
  • Prior enrollment in the trial
  • Hemodynamically unstable atrial fibrillation
  • Untreated hyperthyroidism
  • Known or suspected pregnancy

Treatment and study plan

Anterior-posterior electrode position

Device

Escalating energy shocks (100 J, 150 J, 200 J, 360 J) using anterior-posterior electrode position

Other names: LIFEPAK 20, Physio-Control/Stryker

Anterior-lateral electrode position

Device

Escalating energy shocks (100 J, 150 J, 200 J, 360 J) using anterior-lateral electrode position

Other names: LIFEPAK 20, Physio-Control/Stryker

Primary outcomes

  1. Efficacy: First shock success

    Time frame: Immediately after first cardioversion attempt.

    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.

Secondary outcomes

  1. Efficacy: Successful cardioversion

    Time frame: One minute after 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.

  2. Safety: Number of participants with arrhythmic events during and after cardioversion

    Time frame: Within 2 hours after cardioversion (until discharge)

    Secondary safety endpoints will be arrhythmia during and after cardioversion (asystole, transient bradycardia, ventricular arrhythmia, atrioventricular block, recurrence of atrial fibrillation)

  3. Safety: Number of participants with skin-discomfort, skin burns or itching

    Time frame: Two hours after cardioversion (at discharge)

    Patient-reported peri-procedural discomfort when asked at discharge.

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

  • Randers Regional Hospital
  • Regionshospitalet Horsens
  • Regionshospitalet Viborg, Skive

Registry information

Official study title

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

Acronym: EPIC

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jan 25, 2019
Registry last updated
Oct 8, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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