Atrial Fibrillation
Conditions
Keywords
Atrial fibrillation, Electrical cardioversion, Pharmacological cardioversion, Rhythm control, Rate control
Brief summary
A symptomatic episode of the heart rhythm disorder 'atrial fibrillation' (AF) is a frequent reason for visits to the emergency department. Currently, in the majority of cases, immediate (electrical or pharmacological) cardioversion is chosen, while atrial fibrillation terminates spontaneously in 70% of the cases within 24 hours. A wait-and-see approach with rate-control medication only, and when needed cardioversion within 48 hours of onset of symptoms, could be effective, safe and more cost-effective than current standard of care and could lead to a higher quality of life.
Interventions
Sponsors
Study design
Eligibility
Inclusion criteria
* ECG with atrial fibrillation at the emergency department * Heart rate \> 70bpm * Symptoms most probable due to atrial fibrillation * Duration of symptoms \< 36 hours * \> 18 years of age * Able and willing to sign informed consent * Able and willing to use MyDiagnostick
Exclusion criteria
* Signs of myocardial infarction on ECG * Hemodynamic instability (systolic blood pressure \< 100mm Hg, heart rate \> 170 bpm) * Presence of pre-excitation syndrome * History of Sick Sinus Syndrome * History of unexplained syncope * History of persistent AF (episode of AF lasting more than 48 hours) * Acute heart failure * Currently enrolled in another clinical trial * Deemed unsuitable for participation by attending physician
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 12-lead ECG | 4 weeks | Presence of sinus rhythm on ECG |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to conversion to sinus rhythm (Holter monitor) | 48 hours | Intervention group only |
| Quality of life (SF-36) | Baseline, 4 weeks, 6 months, 12 months | — |
| Quality of Life (AFEQT) | Baseline, 4 weeks, 6 months, 12 months | — |
| Time to first recurrence of Atrial Fibrillation | 1 month | Monitoring through handheld device |
| Total health care and societal costs | 1 year | — |
| One-year follow-up of Major Adverse Cerebrovascular or Cardiovascular Events | One year | — |
Countries
Netherlands