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Anteroposterior Versus Anterolateral Electrode Position for Electrical Cardioversion of Atrial Fibrillation (SHOCK-VECTOR)

Primary Purpose

Atrial Fibrillation, Atrial Flutter

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Anterolateral electrode position
Anteroposterior electrode position
Manual pressure
Sponsored by
McMaster University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • Hamilton Health SciencesRecruiting
  • St Joseph's Healthcare HamiltonRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Anterolateral shock vector

Anteroposterior shock vector

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

First-shock cardioversion success
Reversion to sinus rhythm (5 consecutive P waves within 5 seconds of shock)

Secondary Outcome Measures

Cumulative cardioversion success for anterolateral versus anteroposterior placement afte
Reversion to sinus rhythm (5 consecutive P waves within 5 seconds of shock)
Second shock success for manual pressure versus none
Reversion to sinus rhythm (5 consecutive P waves within 5 seconds of shock)

Full Information

First Posted
August 19, 2022
Last Updated
March 13, 2023
Sponsor
McMaster University
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1. Study Identification

Unique Protocol Identification Number
NCT05511389
Brief Title
Anteroposterior Versus Anterolateral Electrode Position for Electrical Cardioversion of Atrial Fibrillation
Acronym
SHOCK-VECTOR
Official Title
A Randomized Controlled Trial of Anterior-posterior Versus Anterior-lateral Shock Vectors for Electrical Cardioversion of Atrial Fibrillation
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 22, 2023 (Actual)
Primary Completion Date
June 2026 (Anticipated)
Study Completion Date
July 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
McMaster University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation, Atrial Flutter

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
With a partial factorial randomization to manual pressure versus not (second intervention) if the first randomized attempt is unsuccessful at restoring normal heart rhythm
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Anterolateral shock vector
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Anteroposterior shock vector
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Anterolateral electrode position
Intervention Description
As described previously
Intervention Type
Other
Intervention Name(s)
Anteroposterior electrode position
Intervention Description
As described previously
Intervention Type
Other
Intervention Name(s)
Manual pressure
Intervention Description
Manual pressure applied to the anterior electrode
Primary Outcome Measure Information:
Title
First-shock cardioversion success
Description
Reversion to sinus rhythm (5 consecutive P waves within 5 seconds of shock)
Time Frame
At time of intervention
Secondary Outcome Measure Information:
Title
Cumulative cardioversion success for anterolateral versus anteroposterior placement afte
Description
Reversion to sinus rhythm (5 consecutive P waves within 5 seconds of shock)
Time Frame
At time of intervention
Title
Second shock success for manual pressure versus none
Description
Reversion to sinus rhythm (5 consecutive P waves within 5 seconds of shock)
Time Frame
At time of intervention
Other Pre-specified Outcome Measures:
Title
Descriptive analysis of techniques and results for third, unrandomized, clinician directed shock
Description
Reversion to sinus rhythm (5 consecutive P waves within 5 seconds of shock)
Time Frame
At time of intervention
Title
First shock cardioversion success (subgroup analysis) by electrode position
Description
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
Time Frame
At time of intervention
Title
Second shock cardioversion success by manual pressure versus none
Description
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
Time Frame
At time of intervention
Title
Total number of shocks by electrode positioning
Description
Reversion to sinus rhythm (5 consecutive P waves within 5 seconds of shock)
Time Frame
At time of intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
William McIntyre, MD
Email
william.mcintyre@phri.ca
Facility Information:
Facility Name
Hamilton Health Sciences
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8L2X2
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
William McIntyre, MD
Email
William.mcintyre@Phri.ca
Facility Name
St Joseph's Healthcare Hamilton
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N4A6
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
William McIntyre, MD
Email
william.mcintyre@phri.ca

12. IPD Sharing Statement

Learn more about this trial

Anteroposterior Versus Anterolateral Electrode Position for Electrical Cardioversion of Atrial Fibrillation

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