Electrode Positions in Cardioverting Atrial Fibrillation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

468 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-19

Study Completion Date

2020-10-02

Brief Summary

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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).

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Detailed Description

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Conditions

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Atrial Fibrillation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Anterior-posterior electrode position

Intervention Type DEVICE

Escalating energy shocks (100 J, 150 J, 200 J, 360 J) using anterior-posterior 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.

Group Type ACTIVE_COMPARATOR

Anterior-lateral electrode position

Intervention Type DEVICE

Escalating energy shocks (100 J, 150 J, 200 J, 360 J) using anterior-lateral electrode position

Interventions

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Anterior-posterior electrode position

Escalating energy shocks (100 J, 150 J, 200 J, 360 J) using anterior-posterior electrode position

Intervention Type DEVICE

Anterior-lateral electrode position

Escalating energy shocks (100 J, 150 J, 200 J, 360 J) using anterior-lateral electrode position

Intervention Type DEVICE

Other Intervention Names

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LIFEPAK 20, Physio-Control/Stryker LIFEPAK 20, Physio-Control/Stryker

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No