Patients with paroxysmal or persistent atrial fibrillation (AF) reporting at the first heart aid.
Conditions
Interventions
Trade Name: Brinavess
Product Name: Brinavess
Product Code: SUB30707
Pharmaceutical Form: Concentrate for solution for infusion
CAS Number: 748810-28-8
Other descriptive name: VERNAKALANT HYDROCHLORID
Sponsors
Maastricht University Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - patients presenting with paroxysmal or persistent AF - eligible for treatment with flecainide or vernakalant infusion to restore sinus rhythm - receiving adequate anticoagulant therapy (or having an episode of AF lasting =65 years) yes F.1.3.1 Number of subjects for this age range 30
Exclusion criteria
Exclusion criteria: - atrial flutter - contra-indications for receiving flecainide or vernakalant infusion 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 |
|---|---|
| Main Objective: To compare the atrial contractility by means of echocardiography between patients receiving flecainide and vernakalant i.v. after conversion to sinus rhythm.;Secondary Objective: a. To compare the conversion rate of AF between patients receiving flecainide and vernakalant i.v. b. To compare the recurrence rate of AF four weeks after successful cardioversion between patients receiving flecainide and vernakalant i.v.;Primary end point(s): Echocardiography to evaluate atrial contractility after conversion to sinus rhythm.;Timepoint(s) of evaluation of this end point: Directly after successfull cardioversion. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): a. Conversion rate to sinus rhythm. b. Recurrence of AF at one month follow-up.;Timepoint(s) of evaluation of this end point: a. One hour after start infusion vernakalant or flecainide. b. One month after first heart aid visit (follow-up). | — |
Countries
Netherlands
Contacts
Public ContactSecretary Cardiology
Maastricht University Medical Center
Outcome results
None listed