Electrode Positions in Cardioverting Atrial Fibrillation

Atrial Fibrillation Clinical Trial

— EPIC  

Official title:

Comparison of Anterior-Posterior Versus Anterior-Lateral Electrode Position in Cardioverting Atrial Fibrillation - A Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03817372
• Other study ID #: 66051
• Status: Completed
• Phase: N/A
• Start date: February 19, 2019
• Est. completion date: October 2, 2020

Study information

• Verified date: October 2020
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 468
• Est. completion date: October 2, 2020
• Est. primary completion date: October 2, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Atrial fibrillation (documented on an ECG-12)

2. Able and willing to sign informed consent

3. Age = 18 years

4. 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:

1. Implanted pacemaker and/or cardioverter defibrillator (ICD)

2. Prior enrollment in the trial

3. Hemodynamically unstable atrial fibrillation

4. Untreated hyperthyroidism

5. Known or suspected pregnancy

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Device:
• Anterior-posterior electrode position
Escalating energy shocks (100 J, 150 J, 200 J, 360 J) using anterior-posterior electrode position
• Anterior-lateral electrode position
Escalating energy shocks (100 J, 150 J, 200 J, 360 J) using anterior-lateral electrode position

Locations

Country	Name	City	State
Denmark	Horsens Regional Hospital	Horsens
Denmark	Randers Regional Hospital	Randers
Denmark	Viborg Regional Hospital	Viborg

Sponsors (4)

Lead Sponsor	Collaborator
University of Aarhus	Randers Regional Hospital, Regionshospitalet Horsens, Regionshospitalet Viborg, Skive

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Immediately after first cardioversion attempt.
Secondary	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.	One minute after cardioversion
Secondary	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)	Within 2 hours after cardioversion (until discharge)
Secondary	Safety: Number of participants with skin-discomfort, skin burns or itching	Patient-reported peri-procedural discomfort when asked at discharge.	Two hours after cardioversion (at discharge)