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| Name | Class |
|---|---|
| Regionshospitalet Viborg, Skive | OTHER |
| Randers Regional Hospital | OTHER |
| Regionshospitalet Horsens | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anterior-posterior electrode position | Device | Escalating energy shocks (100 J, 150 J, 200 J, 360 J) using anterior-posterior electrode position |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy: Successful 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. | One minute after cardioversion |
| Safety: Number of participants with arrhythmic events during and after cardioversion |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Horsens Regional Hospital | Horsens | 8700 | Denmark | |||
| Randers Regional Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34814700 | Derived | 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. |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| Anterior-lateral electrode position | Device | Escalating energy shocks (100 J, 150 J, 200 J, 360 J) using anterior-lateral electrode position |
|
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Secondary safety endpoints will be arrhythmia during and after cardioversion (asystole, transient bradycardia, ventricular arrhythmia, atrioventricular block, recurrence of atrial fibrillation) |
| Within 2 hours after cardioversion (until discharge) |
| Safety: Number of participants with skin-discomfort, skin burns or itching | Patient-reported peri-procedural discomfort when asked at discharge. | Two hours after cardioversion (at discharge) |
| Randers |
| 8930 |
| Denmark |
| Viborg Regional Hospital | Viborg | 8800 | Denmark |
| D013568 |
| Pathological Conditions, Signs and Symptoms |