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Electrode Positioning for Atrial Fibrillation Cardioversion (SHOCK-VECTOR Trial)

N/A

Recruiting

Research Sponsored by McMaster University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Must not have

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)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at time of intervention

Awards & highlights

No Placebo-Only Group

Summary

This trial will test if electrode placement & physical pressure on the chest can improve restoring normal heart rhythm in people with atrial fibrillation.

Who is the study for?

This trial is for consenting adults set to undergo non-emergency electrical cardioversion for Atrial Fibrillation or Flutter. Participants must be adequately anticoagulated as per guidelines, or have had an echocardiogram to rule out heart clots. Those with skin conditions or wounds preventing electrode placement cannot join.

What is being tested?

The study tests whether placing electrodes on the front-to-back (anteroposterior) or front-to-side (anterolateral) of the chest and applying manual pressure improves the success of restoring normal heart rhythm in patients with atrial fibrillation.

What are the potential side effects?

Electrical cardioversion may cause discomfort, skin irritation at the electrode sites, brief arrhythmias, or more rarely complications like blood clots if not properly anticoagulated before the procedure.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I haven't had the proper blood thinning treatment or a specific heart scan.

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I cannot have treatments placed on certain parts of my body due to skin conditions or wounds.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at time of intervention

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at time of intervention

This trial's timeline: 3 weeks for screening, Varies for treatment, and at time of intervention for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

First-shock cardioversion success

Secondary study objectives

Cumulative cardioversion success for anterolateral versus anteroposterior placement afte

Second shock success for manual pressure versus none

Other study objectives

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

Electric Countershock

Second shock cardioversion success by manual pressure versus none

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Active Control

Group I: Anterolateral shock vectorActive Control2 Interventions

Patients with electrodes placed on the chest to obtain an anterolateral (front-to-side placement; also known as anteroapical) shock vector. If first shock is unsuccessful, participants who proceed to a second shock will be randomized to manual pressure versus none but electrode placement will remain the same.

Group II: Anteroposterior shock vectorActive Control2 Interventions

Patients with electrodes placed on the chest to obtain an anteroposterior (front-to-back placement) shock vector. If first shock is unsuccessful, participants who proceed to a second shock will be randomized to manual pressure versus none but electrode placement will remain the same.

0 / 2Eligibility criteria met