Acute Cardioversion Versus Wait And See-approach for Symptomatic Atrial Fibrillation in the Emergency Department

Study Overview
=================
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.

Official Title
-----------------
Acute Cardioversion Versus Wait And See-approach for Symptomatic Atrial Fibrillation in the Emergency Department (RACE 7 ACWAS-trial)

Conditions
-----------------
Atrial Fibrillation

Intervention / Treatment
-----------------
* Drug: Pharmacological cardioversion - Flecainide
* Procedure: Electrical cardioversion
* Drug: Metoprolol
* Drug: Verapamil
* Drug: Digoxin
* Drug: Pharmacological cardioversion - Amiodarone


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard Care<br>Pharmacological cardioversion and/or electrical cardioversion | Drug: Pharmacological cardioversion - Flecainide<br> <br> * Other names: Tambocor;Procedure: Electrical cardioversion<br> <br> Drug: Pharmacological cardioversion - Amiodarone<br> <br> * Other names: Cordarone;|
| Experimental: Wait-and-see Approach<br>Rate control drugs only (metoprolol, verapamil or digoxin) | Drug: Metoprolol<br> <br> * Other names: Selokeen;Drug: Verapamil<br> <br> * Other names: Isoptin;Drug: Digoxin<br> <br> * Other names: Lanoxin;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 12-lead ECG | Presence of sinus rhythm on ECG | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to conversion to sinus rhythm (Holter monitor) | Intervention group only | 48 hours | 
| 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 | Monitoring through handheld device | 1 month | 
| Total health care and societal costs |  | 1 year | 
| Quality of Life (AFEQT) |  | Baseline, 4 weeks, 6 months, 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Atrial fibrillation, Electrical cardioversion, Pharmacological cardioversion, Rhythm control, Rate control