Atrial FibrillationEPICNCT03817372
Electrode Positions in Cardioverting Atrial Fibrillation
A study testing Anterior-posterior electrode position and Anterior-lateral electrode position in people with Atrial Fibrillation, run by University of Aarhus at 3 sites in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Anterior-posterior electrode position and Anterior-lateral electrode position
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 468 participants
- Where
- 3 sitesDenmark
- Study dates
- 19 Feb 2019to 2 Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- 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).
Who cannot join
- Implanted pacemaker and/or cardioverter defibrillator (ICD)
- Prior enrollment in the trial
- Hemodynamically unstable atrial fibrillation
- Untreated hyperthyroidism
- Known or suspected pregnancy
Trial locations and contacts
3 sites in 1 country.
Denmark3 sites
Horsens Regional Hospital
Horsens, 8700
Randers Regional Hospital
Randers, 8930
Viborg Regional Hospital
Viborg, 8800
About this study
Official title: Comparison of Anterior-Posterior Versus Anterior-Lateral Electrode Position in Cardioverting Atrial Fibrillation - A Randomized Clinical Trial
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).
- Conditions
- Atrial Fibrillation
- Being tested
- Anterior-posterior electrode position, Anterior-lateral electrode position
- Keywords
- Cardioversion, Electrode position
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anterior-posterior electrode positionDevice
Also called LIFEPAK 20, Physio-Control/Stryker
Escalating energy shocks (100 J, 150 J, 200 J, 360 J) using anterior-posterior electrode position
Anterior-lateral electrode positionDevice
Also called LIFEPAK 20, Physio-Control/Stryker
Escalating energy shocks (100 J, 150 J, 200 J, 360 J) using anterior-lateral electrode position
| Study group | Role | What they receive |
|---|---|---|
| Anterior-posterior electrode position | Active comparator | 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. Receives: Device: Anterior-posterior electrode position |
| Anterior-lateral electrode position | Active comparator | 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. Receives: Device: Anterior-lateral electrode position |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Immediately after first cardioversion attempt.
Secondary outcomes (3)
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.
Measured: One minute after cardioversion
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)
Measured: Within 2 hours after cardioversion (until discharge)
Safety: Number of participants with skin-discomfort, skin burns or itching
Patient-reported peri-procedural discomfort when asked at discharge.
Measured: Two hours after cardioversion (at discharge)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2019
- Study start19 Feb 2019
- Primary completion2 Oct 2020
- Study completion2 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by University of AarhusThe 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
- Masking
- None (open label)
- Enrolment
- 468 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Regionshospitalet Viborg, Skive, Randers Regional Hospital, Regionshospitalet Horsens
- Responsible party
- Sponsor
- Investigators
- Anders S Schmidt, MD, Principal investigator, Randers Regional HospitalConsultant cardiologist Andi E Albertsen, MD, PhD, Study director, Viborg Regional HospitalProfessor Bo Løfgren, MD, PhD, FESC, FAHA, Study chair, University of Aarhus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03817372
- Sponsor's protocol ID
- 66051
- Acronym
- EPIC
- Status last verified
- Oct 2020
- First submitted
- 21 Jan 2019
- Last updated
- 8 Oct 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 34814700
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Anterior-Posterior Versus Anterior-Lateral Electrode Position in Cardioverting Atrial Fibrillation - A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03817372
- Acronym / sponsor ID
- EPIC / 66051
- Conditions
- Atrial Fibrillation
- Keywords
- Cardioversion, Electrode position
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 468 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Regionshospitalet Viborg, Skive, Randers Regional Hospital, Regionshospitalet Horsens
- Study start
- 19 Feb 2019 (actual)
- Primary completion
- 2 Oct 2020 (actual)
- Study completion
- 2 Oct 2020 (actual)
- First posted
- 25 Jan 2019 (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, 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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anterior-posterior electrode position | Active comparator | Device: Anterior-posterior electrode positionThe 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. |
| Anterior-lateral electrode position | Active comparator | Device: Anterior-lateral electrode positionThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (5 listed)
- Implanted pacemaker and/or cardioverter defibrillator (ICD)
- Prior enrollment in the trial
- Hemodynamically unstable atrial fibrillation
- Untreated hyperthyroidism
- Known or suspected pregnancy
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 |
|---|---|---|
| Anterior-posterior electrode positionAlso: LIFEPAK 20, Physio-Control/StrykerEscalating energy shocks (100 J, 150 J, 200 J, 360 J) using anterior-posterior electrode position | Device | Anterior-posterior electrode position |
| Anterior-lateral electrode positionAlso: LIFEPAK 20, Physio-Control/StrykerEscalating energy shocks (100 J, 150 J, 200 J, 360 J) using anterior-lateral electrode position | Device | Anterior-lateral electrode position |
Primary outcome
Efficacy: First shock success
Time frame: Immediately after first cardioversion attempt.
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.
3 secondary outcomes
Efficacy: Successful cardioversion
Time frame: One minute after cardioversion
Safety: Number of participants with arrhythmic events during and after cardioversion
Time frame: Within 2 hours after cardioversion (until discharge)
Safety: Number of participants with skin-discomfort, skin burns or itching
Time frame: Two hours after cardioversion (at discharge)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2020.
- Derived from this study: PubMed 34814700Schmidt 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.
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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. This study is not recruiting at the moment.
Anders S Schmidt, MD principal investigator
Randers Regional Hospital
Consultant cardiologist Andi E Albertsen, MD, PhD study director
Viborg Regional Hospital
Professor Bo Løfgren, MD, PhD, FESC, FAHA study chair
University of Aarhus
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anterior-posterior electrode position and Anterior-lateral electrode position in people with Atrial Fibrillation, run by University of Aarhus at 3 sites in Denmark.
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 4 inclusion and 5 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: finished, as of the sponsor's last update on 8 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Denmark. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy: First shock success (time frame: Immediately after first cardioversion attempt.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03817372, which also lists 1 linked publication.
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 8 Oct 2020.