Electrode Positions in Cardioverting Atrial Fibrillation (EPIC)
Primary Purpose
Atrial Fibrillation
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Anterior-posterior electrode position
Anterior-lateral electrode position
Sponsored by
About this trial
This is an interventional treatment trial for Atrial Fibrillation focused on measuring Cardioversion, Electrode position
Eligibility Criteria
Inclusion Criteria:
- Atrial fibrillation (documented on an ECG-12)
- Able and willing to sign informed consent
- Age ≥ 18 years
- Anticoagulation according to guidelines (Patients with atrial fibrillation for >48 hours will be required to have a documented weekly international normalized ratio (INR) ≥2.0 (including within 48 hours of cardioversion) or treatment with non-vitamin K oral anticoagulant for three weeks or longer. Alternatively, a transoesophageal echocardiogram documenting the absence of intracardiac thrombi is accepted and cardioversion can be performed on treatment with low molecular weight heparin).
Exclusion Criteria:
- Implanted pacemaker and/or cardioverter defibrillator (ICD)
- Prior enrollment in the trial
- Hemodynamically unstable atrial fibrillation
- Untreated hyperthyroidism
- Known or suspected pregnancy
Sites / Locations
- Horsens Regional Hospital
- Randers Regional Hospital
- Viborg Regional Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Anterior-posterior electrode position
Anterior-lateral electrode position
Arm Description
The anterior electrode is placed in the left parasternal area (precordium). The posterior electrode is placed in the left lower-scapular region with the electrode edge left to the spinal column.
The anterior electrode is placed in the right parasternal area below the clavicle. The lateral electrode is placed with the center of the electrode in the left mid-axillary line in level with the V6 electrocardiogram electrode.
Outcomes
Primary Outcome Measures
Efficacy: First shock success
The primary endpoint will be first shock efficacy, i.e. the proportion of patients in sinus rhythm for at least one minute immediately after an initial shock of 100 J.
Secondary Outcome Measures
Efficacy: Successful cardioversion
The secondary efficacy endpoint will be cardioversion success, i.e. the proportion of patients in sinus rhythm for at least one minute after end of protocol.
Safety: Number of participants with arrhythmic events during and after cardioversion
Secondary safety endpoints will be arrhythmia during and after cardioversion (asystole, transient bradycardia, ventricular arrhythmia, atrioventricular block, recurrence of atrial fibrillation)
Safety: Number of participants with skin-discomfort, skin burns or itching
Patient-reported peri-procedural discomfort when asked at discharge.
Full Information
NCT ID
NCT03817372
First Posted
January 21, 2019
Last Updated
October 6, 2020
Sponsor
University of Aarhus
Collaborators
Regionshospitalet Viborg, Skive, Randers Regional Hospital, Regionshospitalet Horsens
1. Study Identification
Unique Protocol Identification Number
NCT03817372
Brief Title
Electrode Positions in Cardioverting Atrial Fibrillation
Acronym
EPIC
Official Title
Comparison of Anterior-Posterior Versus Anterior-Lateral Electrode Position in Cardioverting Atrial Fibrillation - A Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
February 19, 2019 (Actual)
Primary Completion Date
October 2, 2020 (Actual)
Study Completion Date
October 2, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus
Collaborators
Regionshospitalet Viborg, Skive, Randers Regional Hospital, Regionshospitalet Horsens
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Atrial fibrillation is the most common heart rhythm disorder, and the incidence is rapidly increasing. Cardioversion using an electrical shock (DC-cardioversion) is an important treatment to reduce symptoms and improve patient's quality-of-life. The treatment is performed by applying gel electrodes to the chest. Cardioversion is not always successful, and it is unknown which electrode-position provides the optimal efficacy.
This study aims to compare two electrode positions, which are in clinical use: Anterior-posterior (left front and left back) versus anterior-lateral (right front and left side of the chest).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
Cardioversion, Electrode position
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
468 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Anterior-posterior electrode position
Arm Type
Active Comparator
Arm Description
The anterior electrode is placed in the left parasternal area (precordium). The posterior electrode is placed in the left lower-scapular region with the electrode edge left to the spinal column.
Arm Title
Anterior-lateral electrode position
Arm Type
Active Comparator
Arm Description
The anterior electrode is placed in the right parasternal area below the clavicle. The lateral electrode is placed with the center of the electrode in the left mid-axillary line in level with the V6 electrocardiogram electrode.
Intervention Type
Device
Intervention Name(s)
Anterior-posterior electrode position
Other Intervention Name(s)
LIFEPAK 20, Physio-Control/Stryker
Intervention Description
Escalating energy shocks (100 J, 150 J, 200 J, 360 J) using anterior-posterior electrode position
Intervention Type
Device
Intervention Name(s)
Anterior-lateral electrode position
Other Intervention Name(s)
LIFEPAK 20, Physio-Control/Stryker
Intervention Description
Escalating energy shocks (100 J, 150 J, 200 J, 360 J) using anterior-lateral electrode position
Primary Outcome Measure Information:
Title
Efficacy: First shock success
Description
The primary endpoint will be first shock efficacy, i.e. the proportion of patients in sinus rhythm for at least one minute immediately after an initial shock of 100 J.
Time Frame
Immediately after first cardioversion attempt.
Secondary Outcome Measure Information:
Title
Efficacy: Successful cardioversion
Description
The secondary efficacy endpoint will be cardioversion success, i.e. the proportion of patients in sinus rhythm for at least one minute after end of protocol.
Time Frame
One minute after cardioversion
Title
Safety: Number of participants with arrhythmic events during and after cardioversion
Description
Secondary safety endpoints will be arrhythmia during and after cardioversion (asystole, transient bradycardia, ventricular arrhythmia, atrioventricular block, recurrence of atrial fibrillation)
Time Frame
Within 2 hours after cardioversion (until discharge)
Title
Safety: Number of participants with skin-discomfort, skin burns or itching
Description
Patient-reported peri-procedural discomfort when asked at discharge.
Time Frame
Two hours after cardioversion (at discharge)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Atrial fibrillation (documented on an ECG-12)
Able and willing to sign informed consent
Age ≥ 18 years
Anticoagulation according to guidelines (Patients with atrial fibrillation for >48 hours will be required to have a documented weekly international normalized ratio (INR) ≥2.0 (including within 48 hours of cardioversion) or treatment with non-vitamin K oral anticoagulant for three weeks or longer. Alternatively, a transoesophageal echocardiogram documenting the absence of intracardiac thrombi is accepted and cardioversion can be performed on treatment with low molecular weight heparin).
Exclusion Criteria:
Implanted pacemaker and/or cardioverter defibrillator (ICD)
Prior enrollment in the trial
Hemodynamically unstable atrial fibrillation
Untreated hyperthyroidism
Known or suspected pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anders S Schmidt, MD
Organizational Affiliation
Randers Regional Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Consultant cardiologist Andi E Albertsen, MD, PhD
Organizational Affiliation
Viborg Regional Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Professor Bo Løfgren, MD, PhD, FESC, FAHA
Organizational Affiliation
University of Aarhus
Official's Role
Study Chair
Facility Information:
Facility Name
Horsens Regional Hospital
City
Horsens
ZIP/Postal Code
8700
Country
Denmark
Facility Name
Randers Regional Hospital
City
Randers
ZIP/Postal Code
8930
Country
Denmark
Facility Name
Viborg Regional Hospital
City
Viborg
ZIP/Postal Code
8800
Country
Denmark
12. IPD Sharing Statement
Citations:
PubMed Identifier
34814700
Citation
Schmidt AS, Lauridsen KG, Moller DS, Christensen PD, Dodt KK, Rickers H, Lofgren B, Albertsen AE. Anterior-Lateral Versus Anterior-Posterior Electrode Position for Cardioverting Atrial Fibrillation. Circulation. 2021 Dec 21;144(25):1995-2003. doi: 10.1161/CIRCULATIONAHA.121.056301. Epub 2021 Nov 24.
Results Reference
derived
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Electrode Positions in Cardioverting Atrial Fibrillation
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