Clinical trial NCT03817372: Electrode Positions in Cardioverting Atrial Fibrillation
Official title: Comparison of Anterior-Posterior Versus Anterior-Lateral Electrode Position in Cardioverting Atrial Fibrillation - A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Keywords: Cardioversion
Electrode position
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Regionshospitalet Viborg, Skive
name: Randers Regional Hospital
name: Regionshospitalet Horsens
First posted: 2019-01-25
Enrollment: 468
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: 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

Primary outcomes:
measure: Efficacy: First shock success
timeFrame: Immediately after first cardioversion attempt.
Secondary outcomes:
measure: Efficacy: Successful cardioversion
timeFrame: One minute after cardioversion
measure: Safety: Number of participants with arrhythmic events during and after cardioversion
timeFrame: Within 2 hours after cardioversion (until discharge)
measure: Safety: Number of participants with skin-discomfort, skin burns or itching
timeFrame: Two hours after cardioversion (at discharge)
Other outcomes:
Locations:
city: Horsens
country: Denmark
facility: Horsens Regional Hospital
city: Randers
country: Denmark
facility: Randers Regional Hospital
city: Viborg
country: Denmark
facility: Viborg Regional Hospital
Study officials:
affiliation: Randers Regional Hospital
name: Anders S Schmidt, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Viborg Regional Hospital
name: Consultant cardiologist Andi E Albertsen, MD, PhD
role: STUDY_DIRECTOR
affiliation: University of Aarhus
name: Professor Bo Løfgren, MD, PhD, FESC, FAHA
role: STUDY_CHAIR
References:
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.