Atrial FibrillationSHOCK-VECTORNCT05511389
Anteroposterior Versus Anterolateral Electrode Position for Electrical Cardioversion of Atrial Fibrillation
A study testing Anterolateral electrode position, Anteroposterior electrode position and Manual pressure in people with Atrial Fibrillation and Atrial Flutter, run by McMaster University at 4 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation, Atrial Flutter
- What is being tested?
- Anterolateral electrode position, Anteroposterior electrode position and Manual pressure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,750 participants
- Where
- 4 sitesCanada
- Study dates
- 22 Feb 2023to Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Consenting adult patients scheduled for non-emergent electrical cardioversion of Atrial Fibrillation or Flutter
Who cannot join
- 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)
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada4 sites, 3 recruiting
- Recruiting
Hamilton Health Sciences
Hamilton, Ontario, L8L2X2
William McIntyre, MD, William.mcintyre@Phri.ca
- Active, not recruiting
Institut de cardiologie de Montréal
Montreal, Quebec
- Recruiting
Institut Universitaire De Cardiologie Et De Pneumologie de Québec
Québec, Quebec
Christian Steinberg
- Recruiting
Women's College Hospital
Toronto, Ontario
Husam Abdel-Qadir
About this study
Official title: A Randomized Controlled Trial of Anterior-posterior Versus Anterior-lateral Shock Vectors 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.
Read more
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.
- Conditions
- Atrial Fibrillation, Atrial Flutter
- Being tested
- Anterolateral electrode position, Anteroposterior electrode position, Manual pressure
- Medical subject headings
- Atrial Fibrillation, Atrial Flutter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anterolateral electrode positionOther
As described previously
Anteroposterior electrode positionOther
As described previously
Manual pressureOther
Manual pressure applied to the anterior electrode
| Study group | Role | What they receive |
|---|---|---|
| Anterolateral shock vector | Active comparator | 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. Receives: Other: Anterolateral electrode position; Other: Manual pressure |
| Anteroposterior shock vector | Active comparator | 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. Receives: Other: Anteroposterior electrode position; Other: Manual pressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
First-shock cardioversion success
Reversion to sinus rhythm (5 consecutive P waves within 5 seconds of shock)
Measured: At time of intervention
Secondary outcomes (2)
Cumulative cardioversion success for anterolateral versus anteroposterior placement afte
Reversion to sinus rhythm (5 consecutive P waves within 5 seconds of shock)
Measured: At time of intervention
Second shock success for manual pressure versus none
Reversion to sinus rhythm (5 consecutive P waves within 5 seconds of shock)
Measured: At time of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2022
- Study start22 Feb 2023
- Primary completionJul 2028 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 1,750 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, William F. McIntyre, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05511389
- Sponsor's protocol ID
- 5173
- Acronym
- SHOCK-VECTOR
- Status last verified
- Jul 2026
- First submitted
- 19 Aug 2022
- Last updated
- 16 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Anterior-posterior Versus Anterior-lateral Shock Vectors for Electrical Cardioversion of Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT05511389
- Acronym / sponsor ID
- SHOCK-VECTOR / 5173
- Conditions
- Atrial Fibrillation, Atrial Flutter
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,750 participants (estimated)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Study start
- 22 Feb 2023 (actual)
- Primary completion
- Jul 2028 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 23 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Anterolateral shock vector | Active comparator | Other: Anterolateral electrode position, Other: Manual pressurePatients 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. |
| Anteroposterior shock vector | Active comparator | Other: Anteroposterior electrode position, Other: Manual pressurePatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Consenting adult patients scheduled for non-emergent electrical cardioversion of Atrial Fibrillation or Flutter
Key exclusion criteria (2 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anterolateral electrode positionAs described previously | Other | Anterolateral shock vector |
| Anteroposterior electrode positionAs described previously | Other | Anteroposterior shock vector |
| Manual pressureManual pressure applied to the anterior electrode | Other | Anterolateral shock vector, Anteroposterior shock vector |
Primary outcome
First-shock cardioversion success
Time frame: At time of intervention
Reversion to sinus rhythm (5 consecutive P waves within 5 seconds of shock)
2 secondary outcomes
Cumulative cardioversion success for anterolateral versus anteroposterior placement afte
Time frame: At time of intervention
Second shock success for manual pressure versus none
Time frame: At time of intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anterolateral electrode position, Anteroposterior electrode position and Manual pressure in people with Atrial Fibrillation and Atrial Flutter, run by McMaster University at 4 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact William McIntyre, MD (9055212100 ext. 40631, william.mcintyre@phri.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
First-shock cardioversion success (time frame: At time of intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2026.