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NCT Number: NCT05511389

Anteroposterior Versus Anterolateral Electrode Position for Electrical Cardioversion of Atrial Fibrillation

Atrial fibrillation is the most common heart rhythm disorder (arrhythmia) worldwide. Nearly 40 million people are affected by atrial fibrillation worldwide, and this number is expected to increase by over 50% by 2050. Atrial fibrillation can cause strokes, heart attacks, heart failure, poor quality of life and even death. Almost half a million deaths worldwide are expected to be related to atrial fibrillation by 2050, and many billions of dollars are spent on atrial fibrillation related healthcare in North America every year.

We believe health outcomes for patients with atrial fibrillation, and healthcare costs associated with treating atrial fibrillation could be improved by optimizing existing treatments for atrial fibrillation and maximizing the likelihood of restoring normal heart rhythm. This allows them to benefit from lower stroke risk, better heart function, fewer symptoms and increased quality of life. Restoring normal sinus rhythm earlier prevents atrial fibrillation from causing permanent structural damage to the heart that in turn, makes atrial fibrillation intractable. Furthermore, patients in whom initial attempts to control atrial fibrillation are unsuccessful frequently require more medications or invasive catheter ablation procedures which are costly and carry substantial risk.

Electrical cardioversion is the main way physicians restore normal heart rhythm. In this procedure, the heart is "shocked" back into normal rhythm using two electrodes on the chest. Done correctly, this procedure is safe and effective. Many things are known about electrical cardioversion, for example, the best type and amount of electricity to use. What we don't know is the best position of the electrodes on the chest and whether applying direct, physical pressure to the electrodes makes cardioversion more successful. Our prior research suggests that improving positioning and applying pressure may improve cardioversion, but this finding needs to be verified with a rigorous, dedicated trial.

This study will demonstrate whether front-to-back, or front-to-side placement of the electrodes is more effective for electrical cardioversion of atrial fibrillation. We will also demonstrate whether manually applying pressure to the electrodes makes cardioversion more effective. Should our trial demonstrate a benefit for these techniques, we expect them to be universally applied around the world. Because hundreds of thousands of cardioversions are done each year, even small increases in cardioversion success means thousands fewer patients progress to needing more medications or invasive procedures to manage their atrial fibrillation.

We will study consenting adults presenting for non-urgent cardioversion of their atrial fibrillation. After explaining the study to participants and gaining their consent, we will randomly assign them to front-to-side or front-to-back electrode placement. Patients who remain in atrial fibrillation after the first shock will randomly receive either manual pressure or not. We will compare the success of cardioversion for front-side versus front-back electrode placement, and for manual pressure versus none. We will evaluate success by using electrocardiograms to assess for restoration of the heart rhythm back to normal.

We hypothesize that anterolateral electrode positioning is superior to anteroposterior electrode positioning. We also hypothesize that manual pressure is effective relative to none, when applied in patients who have had one unsuccessful shock already.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hamilton Health Sciences, Hamilton, Ontario, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Consenting adult patients scheduled for non-emergent electrical cardioversion of Atrial Fibrillation or Flutter

Exclusion criteria

  • Insufficiently anticoagulation for cardioversion as per Canadian Cardiovascular Society guidelines or have not undergone trans-esophageal echocardiography to rule out left atrial thrombus
  • Anatomic contraindication to anterolateral or anteroposterior placement (e.g. skin conditions or wounds)

Treatment and study plan

Anterolateral electrode position

Other

As described previously

Anteroposterior electrode position

Other

As described previously

Manual Pressure

Other

Manual pressure applied to the anterior electrode

Primary outcomes

  1. First-shock cardioversion success

    Time frame: At time of intervention

    Reversion to sinus rhythm (5 consecutive P waves within 5 seconds of shock)

Secondary outcomes

  1. Cumulative cardioversion success for anterolateral versus anteroposterior placement afte

    Time frame: At time of intervention

    Reversion to sinus rhythm (5 consecutive P waves within 5 seconds of shock)

  2. Second shock success for manual pressure versus none

    Time frame: At time of intervention

    Reversion to sinus rhythm (5 consecutive P waves within 5 seconds of shock)

Other outcomes

  1. Descriptive analysis of techniques and results for third, unrandomized, clinician directed shock

    Time frame: At time of intervention

    Reversion to sinus rhythm (5 consecutive P waves within 5 seconds of shock)

  2. First shock cardioversion success (subgroup analysis) by electrode position

    Time frame: At time of intervention

    As above; exploratory subgroup analysis of: Males vs females, BMI > 30 vs BMI < 30, First episode atrial fibrillation versus recurrent, Duration of current episode >30 days vs <30 days, Left ventricular ejection fraction > 40% vs <40%, Left atrial volume index >34ml/m2 vs not, Premedication with amiodarone , sotalol or class 1 antiarrhythmic drugs versus not, History of cardiac surgery versus not

  3. Second shock cardioversion success by manual pressure versus none

    Time frame: At time of intervention

    As above; exploratory subgroup analysis of: Males vs females, BMI > 30 vs BMI < 30, First episode atrial fibrillation versus recurrent, Duration of current episode >30 days vs <30 days, Left ventricular ejection fraction > 40% vs <40%, Left atrial volume index >34ml/m2 vs not, Premedication with amiodarone , sotalol or class 1 antiarrhythmic drugs versus not, History of cardiac surgery versus not

  4. Total number of shocks by electrode positioning

    Time frame: At time of intervention

    Reversion to sinus rhythm (5 consecutive P waves within 5 seconds of shock)

Study contacts

Contact information is provided by the study sponsor or research team.

William McIntyre, MD

CONTACT

[email protected]

9055212100 ext. 40631

Sponsors and collaborators

Lead sponsor

McMaster University

Other

Registry information

Official study title

A Randomized Controlled Trial of Anterior-posterior Versus Anterior-lateral Shock Vectors for Electrical Cardioversion of Atrial Fibrillation

Acronym: SHOCK-VECTOR

Important dates

Study start
2023
Primary completion
2028
Study completion
2028
First posted
Aug 23, 2022
Registry last updated
Jul 16, 2026

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

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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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