Electrode Positions in Cardioverting Atrial Fibrillation

NCT03817372 | Completed

• 1 other identifier: 66051
• Study Type: interventional
• Target: 468
• Locations: 1 country
• Sites: 3

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).

Conditions

Atrial Fibrillation

Keywords

Cardioversion; Electrode position

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Efficacy: Successful cardioversion

  One minute after cardioversion

• Safety: Number of participants with arrhythmic events during and after cardioversion

  Within 2 hours after cardioversion (until discharge)

• Safety: Number of participants with skin-discomfort, skin burns or itching

  Two hours after cardioversion (at discharge)

Study Arms (2)

Anterior-posterior electrode position

ACTIVE COMPARATOR

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.

Device: Anterior-posterior electrode position

Anterior-lateral electrode position

ACTIVE COMPARATOR

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.

Device: Anterior-lateral electrode position

Interventions

Anterior-posterior electrode position DEVICE

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

Also known as: LIFEPAK 20, Physio-Control/Stryker

Anterior-posterior electrode position

Anterior-lateral electrode position DEVICE

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

Also known as: LIFEPAK 20, Physio-Control/Stryker

Anterior-lateral electrode position

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• Implanted pacemaker and/or cardioverter defibrillator (ICD)
• Prior enrollment in the trial
• Hemodynamically unstable atrial fibrillation
• Untreated hyperthyroidism
• Known or suspected pregnancy

Sponsors & Collaborators

• University of Aarhus: lead
• Regionshospitalet Viborg, Skive: collaborator
• Randers Regional Hospital: collaborator
• Regionshospitalet Horsens: collaborator

Study Sites (3)

Horsens Regional Hospital

Horsens, 8700, Denmark

Location

Randers Regional Hospital

Randers, 8930, Denmark

Location

Viborg Regional Hospital

Viborg, 8800, Denmark

Location

Related Publications (1)

• 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.

  PMID: 34814700 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Anders S Schmidt, MD

  Randers Regional Hospital

  PRINCIPAL INVESTIGATOR

• Consultant cardiologist Andi E Albertsen, MD, PhD

  Viborg Regional Hospital

  STUDY DIRECTOR

• Professor Bo Løfgren, MD, PhD, FESC, FAHA

  University of Aarhus

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2019
• First Posted: January 25, 2019
• Study Start: February 19, 2019
• Primary Completion: October 2, 2020
• Study Completion: October 2, 2020
• Last Updated: October 8, 2020

Record last verified: 2020-10

Locations

DK (3)