RAFF4 Trial: Vernakalant vs. Procainamide for Acute Atrial Fibrillation in the Emergency Department

  • STATUS
    Recruiting
  • End date
    Jun 1, 2024
  • participants needed
    340
  • sponsor
    Ottawa Hospital Research Institute
Updated on 4 October 2022
diabetes
hypertension
stroke
heart failure
warfarin
anticoagulants
heart disease
rivaroxaban
fibrillation
apixaban
edoxaban
cardioversion
procainamide
dabigatran
transesophageal echocardiography
Accepts healthy volunteers

Summary

The objective is to compare IV vernakalant to IV procainamide for the ED management of acute AF patients. If vernakalant proves to be more effective, faster, and safer than IV procainamide, this will give clinicians an important alternative for pharmacological cardioversion of acute AF. The investigators propose a pragmatic comparative effectiveness trial entailing an open label, randomized controlled trial at 12 large Canadian EDs. Study subjects will be randomized to 1 of 2 treatment arms: 1) Patients will receive an initial infusion of 3mg/kg of IV vernakalant over 10 minutes, followed by a second dose of 2mg/kg over 10 minutes, if necessary, or 2) Patients will receive a continuous infusion of 15mg/kg of IV procainamide over 60 minutes. The primary aim will be to compare conversion to normal sinus rhythm between the two drugs. The investigators will include stable patients presenting with an episode of acute AF of at least 3 hours duration, where symptoms require urgent management and where immediate cardioversion is a reasonable option. Using the integrated consent model, research assistants will obtain verbal consent from eligible patients.

Details
Condition Atrial Fibrillation
Treatment Vernakalant, Procainamide
Clinical Study IdentifierNCT04485195
SponsorOttawa Hospital Research Institute
Last Modified on4 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

The investigators will include stable (see below) patients presenting with an episode of
acute non-valvular AF of at least 3 hours duration and no greater than 7 days, where
symptoms require urgent management and where immediate cardioversion is a reasonable option
because
The patient has been adequately anticoagulated for a minimum of 3 weeks (warfarin and
INR > 2.0 or novel oral anticoagulants [dabigatran, rivaroxaban, edoxaban, and
apixaban]), or
The patient is not adequately anticoagulated for > 3 weeks, has no history of stroke
or TIA, and does not have valvular heart disease, AND
i) onset < 12 hours ago, or ii) if onset 12 - 48 hours ago and there are <2 of these
CHADS-65 criteria (age ≥ 65, diabetes, hypertension, heart failure), or iii) negative for
thrombus on transesophageal echocardiography. Of note, we will not exclude patients with
prior episodes of acute AF. Patients will only be enrolled if the attending physician is
confident about time of onset, based upon the patient's symptoms. Physicians are well aware
of the importance of this determination and will not attempt to cardiovert patients
otherwise

Exclusion Criteria

Appropriateness
have permanent (chronic) AF
have valvular heart disease (mitral stenosis, rheumatic or mechanical)
The investigators will exclude patients who have any of the reasons
listed below
convert spontaneously to sinus rhythm prior to randomization
were previously enrolled in the study; or
unable to understand the study and integrated consent due to language barrier
have atrial flutter
and/or cognitive impairment
Safety
increased risk of stroke because onset not clearly <48 hours and not
has severe aortic stenosis
anticoagulated (or abnormal TEE); or do not meet the inclusion criteria a or b
has a systolic blood pressure < 100 mmHg
deemed unstable and require immediate cardioversion: i) systolic blood pressure
<100 mmHg; ii) rapid ventricular preexcitation (Wolff-Parkinson-White syndrome)
iii) acute coronary syndrome - chest pain and acute ischemic changes on ECG; or
has received an IV beta-blocker within the 2 hours prior
iv) pulmonary edema - severe dyspnea requiring immediate IV diuretic, nitrates
or BIPAP
primary presentation was for another condition; examples include pneumonia
has advanced or end-stage liver disease; or
pulmonary embolism, and sepsis
is breast feeding or pregnant (safety not established)
has heart failure Class NYHA III or NYHA IV; left ventricular ejection fraction
<30%; or has clinical or radiological evidence of acute HF
has presented with an acute coronary syndrome or acute decompensated heart
failure, in the last 30 days; or has had a recent myocardial infarction (< 3
months)
has a significantly prolonged QT interval at baseline e.g. uncorrected > 440
msec, congenital or acquired long QT syndrome; or a family history of Long QT
syndrome; or ECG shows QTc >460ms (when heart rate >100 measured by the
Fridericia formula)
has severe bradycardia (heart rate < 55 bpm), sinus node dysfunction, or second
or third degree atrioventricular heart block, in the absence of an in situ
properly functioning pacemaker; or, has Brugada syndrome (genetic disease with
increased risk of sudden cardiac death)
has received an intravenous antiarrhythmic drug Class I, e.g. procainamide, or
Class Ill, e.g. amiodarone or ibutilide, within the prior 4 hours; or currently
takes oral class I or III antiarrhythmic drugs other than amiodarone (last dose <
half-lives before enrollment)
has hypersensitivity to the active substance or to any of the ingredients of
either drug
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