Atrial Fibrillation
Conditions
Keywords
Cardioversion, Electrode position
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).
Interventions
DEVICEAnterior-posterior electrode position
Escalating energy shocks (100 J, 150 J, 200 J, 360 J) using anterior-posterior electrode position
DEVICEAnterior-lateral electrode position
Escalating energy shocks (100 J, 150 J, 200 J, 360 J) using anterior-lateral electrode position
Sponsors
Regionshospitalet Viborg, Skive
Randers Regional Hospital
Regionshospitalet Horsens
University of Aarhus
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| 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. |
Countries
Denmark
Outcome results
None listed