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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

About this trial

This is an interventional treatment trial for Atrial Fibrillation focused on measuring Cardioversion, Electrode position

Eligibility Criteria

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

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

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

Studies a U.S. FDA-regulated Device Product

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

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

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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