Status:
COMPLETED
Trial of Electrical Versus Pharmacological Cardioversion for RAFF in the ED
Lead Sponsor:
Ottawa Hospital Research Institute
Collaborating Sponsors:
The Ottawa Hospital
Conditions:
Atrial Fibrillation
Atrial Flutter
Eligibility:
All Genders
16+ years
Phase:
NA
Brief Summary
Atrial fibrillation (AF) and atrial flutter (AFL) are cardiac rhythm problems where there is an irregular, rapid heart rate. Investigators plan to study Emergency Department (ED) patients with recent-...
Detailed Description
Background: Atrial fibrillation (AF) is characterized by disorganized atrial electrical depolarization leading to an irregular and rapid heart rate and is the most common arrhythmia seen in the emerge...
Eligibility Criteria
Inclusion
- include stable (see below) patients presenting with an episode of RAFF of at least 3 hours duration,
- where symptoms require urgent management and where pharmacological or DC cardioversion is a reasonable option because there is a clear history of:
- onset within 48 hours, or
- onset within 7 days and adequately anticoagulated for \> 4 weeks (warfarin and INR \> 2.0 or newer oral anticoagulants \[dabigatran, rivaroxaban, and apixaban\]), or
- onset within 7 days and no left atrial thrombus on TEE. Of note, Investigators will not exclude patients with prior episodes of RAFF.
Exclusion
- Investigators will exclude patients for the reasons listed below.
- who are unable to give consent;
- who have permanent (chronic) AF;
- whose episode did not clearly start within 48 hours \[or 7 days if anticoagulated / normal TEE\];
- who are 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 iv) pulmonary edema - severe dyspnea requiring immediate IV diuretic, nitrates, or BIPAP;
- whose primary presentation was for another condition; examples include pneumonia, pulmonary embolism, and sepsis;
- who convert spontaneously to sinus rhythm prior to randomization; or
- who were previously enrolled in the study.
- Safety Exclusions:
- who are known to have severe heart failure (left ventricular ejection fraction \<30% or have clinical or radiological evidence of acute HF);
- whose heart rate \< 55 bpm;
- who have 3rd degree AV block or complete LBBB or a history of 2nd or 3rd degree AV block (in the absence of a permanent pacemaker or implantable cardioverter-defibrillator \[ICD\]);
- whose ECG shows QTc \>460ms;
- who have Brugada syndrome (genetic disease with increased risk of sudden cardiac death);
- who currently take class I or III antiarrhythmic drugs (last dose \< 5 half-lives before enrolment) except Amiodarone;
- who have hypersensitivity to procainamide, procaine, other ester-type local anesthetics, or any component of the formulation;
- who have had a recent myocardial infarction (\< 3 months);
- who have these chronic diseases: renal failure (GFR \<60 mL/min/1.73m2) or liver disease; or
- who are breast feeding or pregnant
Key Trial Info
Start Date :
July 18 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 31 2018
Estimated Enrollment :
396 Patients enrolled
Trial Details
Trial ID
NCT01891058
Start Date
July 18 2013
End Date
October 31 2018
Last Update
July 22 2019
Active Locations (10)
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1
Foothills Medical Centre
Calgary, Alberta, Canada, 2TN 1M7
2
Rockyview General Hospital
Calgary, Alberta, Canada
3
University of Alberta Hospital
Edmonton, Alberta, Canada, T6G 2B7
4
Vancouver General Hospital
Vancouver, British Columbia, Canada, V5Z 1M9