Atrial Fibrillation
Conditions
Keywords
Atrial fibrillation, Vernakalant, Flecainide, Echocardiography
Brief summary
Atrial fibrillation (AF) is associated with decreased atrial contractility which is associated with stroke. Decreased contractility becomes apparent after cardioversion of atrial fibrillation, a short period (weeks) during which stroke risk is increased. Improved contractility immediately after cardioversion may prevent arrhythmia progression. In addition, it may reduce the stroke risk. Vernakalant is a new antiarrhythmic drug able to convert atrial fibrillation to sinus rhythm and at the same time increase atrial contractility. The latter has not yet been shown in humans and is subject of the present investigation. Our hypothesis is that in humans the contractility of the atria is higher after administration of vernakalant compared to flecainide. If indeed vernakalant improves atrial contractility after cardioversion further studies into the effect on long-term arrhythmia progression and stroke prevention may follow.
Interventions
DRUGVernakalant
10-minute infusion of 3 mg/kg vernakalant, followed by a 15 minute observation period. If the patient is still in atrial fibrillation, an additional 10-minute infusion of 2 mg/kg vernakalant will be given.
DRUGFlecainide
10-minute infusion of 2 mg/kg (maximal 150 mg)
Sponsors
Maastricht University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* persistent AF or paroxysmal AF * eligible for treatment with vernakalant or flecainide infusion to restore sinus rhythm * receiving adequate anticoagulant therapy (or having an episode of AF lasting \< 24 hours)
Exclusion criteria
* refusal or inability to give informed consent to participate in this study * atrial flutter * contra-indications for receiving vernakalant or flecainide according to MUMC+ protocol (unstable hemodynamic condition, LVEF \< 40%, inadequate potassium levels, acute ischaemia, sinus node dysfunction) * age \< 18 years
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Atrial contractility measured by echocardiography | After successful cardioversion to sinus rhythm (this can be during infusion of medication or during the first hour after infusion) an echocardiography will be performed within one hour. | Echocardiography will be performed when the patient has sinus rhythm. Transmitral flow will be measured by pulsed Doppler from an apical four chamber view. Peak velocities of the early filling (E) wave and atrial filling (A) will be determined. We will also determine the E/A ratio and the atrial volumes and the total atrial conduction time (PA-TVI). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Conversion to sinus rhythm | Within one hour after drug administration | Heart rhythm will be assessed on monitor and confirmed on ECG. |
| Recurrence of AF | At one month follow-up | Heart rhythm will be assessed by ECG. |
Countries
Netherlands
Contacts
Primary ContactIone Limantoro, MD
Backup ContactHarry Crijns, MD, PhD
Outcome results
None listed