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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at time of intervention
Awards & highlights
SHOCK-VECTOR Trial 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.Check my eligibility
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.See study design
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.
SHOCK-VECTOR Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at time of intervention
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at time of intervention
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
First-shock cardioversion success
Secondary outcome measures
Cumulative cardioversion success for anterolateral versus anteroposterior placement afte
Second shock success for manual pressure versus none
Other outcome measures
Descriptive analysis of techniques and results for third, unrandomized, clinician directed shock
Electric Countershock
Second shock cardioversion success by manual pressure versus none
+1 moreSHOCK-VECTOR 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.
Find a Location
Who is running the clinical trial?
McMaster UniversityLead Sponsor
884 Previous Clinical Trials
2,596,816 Total Patients Enrolled
10 Trials studying Atrial Fibrillation
9,005 Patients Enrolled for Atrial Fibrillation
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am an adult who has agreed to a planned electrical cardioversion for Atrial Fibrillation or Flutter.I haven't had the proper blood thinning treatment or a specific heart scan.I cannot have treatments placed on certain parts of my body due to skin conditions or wounds.
Research Study Groups:
This trial has the following groups:- Group 1: Anterolateral shock vector
- Group 2: Anteroposterior shock vector
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any enrollment openings for this research investigation?
"Affirmative. Clinicaltrials.gov's data indicates that this clinical trial, first advertised on February 22nd 2023, is currently recruiting participants. 1500 individuals need to be enrolled between two medical centers."
Answered by AI
How many participants have joined the clinical trial thus far?
"Affirmative. The clinicaltrials.gov website confirms that this medical research is still recruiting participants, which was first posted on February 22nd 2023 and recently updated on March 13th 2023. 1500 patients are required to be enrolled across two different sites."
Answered by AI
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