Acute Cardioversion Versus Wait And See-approach for Symptomatic Atrial Fibrillation in the Emergency Department
- Conditions
- Atrial Fibrillation
- Interventions
- Drug: Pharmacological cardioversion - FlecainideProcedure: Electrical cardioversionDrug: Pharmacological cardioversion - Amiodarone
- Registration Number
- NCT02248753
- Lead Sponsor
- Maastricht University Medical Center
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 437
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Standard Care Pharmacological cardioversion - Flecainide Pharmacological cardioversion and/or electrical cardioversion Standard Care Pharmacological cardioversion - Amiodarone Pharmacological cardioversion and/or electrical cardioversion Standard Care Electrical cardioversion Pharmacological cardioversion and/or electrical cardioversion Wait-and-see Approach Verapamil Rate control drugs only (metoprolol, verapamil or digoxin) Wait-and-see Approach Metoprolol Rate control drugs only (metoprolol, verapamil or digoxin) Wait-and-see Approach Digoxin Rate control drugs only (metoprolol, verapamil or digoxin)
- Primary Outcome Measures
Name Time Method 12-lead ECG 4 weeks Presence of sinus rhythm on ECG
- Secondary Outcome Measures
Name Time Method Quality of life (SF-36) Baseline, 4 weeks, 6 months, 12 months One-year follow-up of Major Adverse Cerebrovascular or Cardiovascular Events One year Time to first recurrence of Atrial Fibrillation 1 month Monitoring through handheld device
Total health care and societal costs 1 year Quality of Life (AFEQT) Baseline, 4 weeks, 6 months, 12 months Time to conversion to sinus rhythm (Holter monitor) 48 hours Intervention group only
Trial Locations
- Locations (15)
VU University Medical Center
🇳🇱Amsterdam, Netherlands
Antonius Ziekenhuis
🇳🇱Sneek, Netherlands
University Medical Center Groningen
🇳🇱Groningen, Netherlands
Amphia Hospital
🇳🇱Breda, Netherlands
Catharina Ziekenhuis
🇳🇱Eindhoven, Netherlands
Medisch Spectrum Twente
🇳🇱Enschede, Netherlands
Alrijne Hospital
🇳🇱Leiderdorp, Netherlands
Maastricht University Medical Center
🇳🇱Maastricht, Netherlands
Zuyderland Medical Center
🇳🇱Heerlen, Netherlands
Diakonessenhuis
🇳🇱Utrecht, Netherlands
St. Antonius Hospital
🇳🇱Nieuwegein, Netherlands
Franciscus Gasthuis
🇳🇱Rotterdam, Netherlands
VieCuri Medical Center
🇳🇱Venlo, Netherlands
HagaZiekenhuis
🇳🇱The Hague, Netherlands
St. Elisabeth - TweeSteden Hospital
🇳🇱Tilburg, Netherlands