Electrode Positions in Cardioverting Atrial Fibrillation

Not Applicable

Completed

• Conditions: Atrial Fibrillation
• Interventions: Device: Anterior-lateral electrode position; Device: Anterior-posterior electrode position

• Registration Number: NCT03817372
• Lead Sponsor: University of Aarhus

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).

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-01-21
• Study First Submitted QC: 2019-01-24
• Study First Posted: 2019-01-25
• Study Start: 2019-02-19
• Status Verified: 2020-10
• Primary Completion: 2020-10-02
• Study Completion: 2020-10-02
• Last Update Submitted: 2020-10-06
• Last Update Posted: 2020-10-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 468

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).

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Anterior-lateral electrode position	Anterior-lateral electrode position	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.
Anterior-posterior electrode position	Anterior-posterior electrode position	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.

Primary Outcome Measures

Name	Time	Method
Efficacy: First shock success	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.

Secondary Outcome Measures

Name	Time	Method
Safety: Number of participants with skin-discomfort, skin burns or itching	Two hours after cardioversion (at discharge)	Patient-reported peri-procedural discomfort when asked at discharge.
Efficacy: Successful cardioversion	One minute after 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	Within 2 hours after cardioversion (until discharge)	Secondary safety endpoints will be arrhythmia during and after cardioversion (asystole, transient bradycardia, ventricular arrhythmia, atrioventricular block, recurrence of atrial fibrillation)

Trial Locations

Locations (3)

Randers Regional Hospital; 🇩🇰 Randers, Denmark

Viborg Regional Hospital; 🇩🇰 Viborg, Denmark

Horsens Regional Hospital; 🇩🇰 Horsens, Denmark