Trial of Electrical Versus Pharmacological Cardioversion for RAFF in the ED (RAFF-2)
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|ClinicalTrials.gov Identifier: NCT01891058|
Recruitment Status : Completed
First Posted : July 2, 2013
Last Update Posted : July 22, 2019
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-onset episodes of AF or AFL (RAFF) where rapid heart rate requires urgent treatment to restore normal heart rhythm. RAFF is the most common rhythm disorder managed in the ED. Investigators recently showed that doctors use a wide variety of treatment approaches in Canadian EDs for RAFF. Also, the Canadian Cardiovascular Society Guidelines indicate that there have not been enough studies to know if the best treatment is to use an electrical shock (Shock Only) or drugs followed by shock (Drug-Shock). Investigators believe that Drug-Shock approach will be more effective and will help avoid an electric shock for many patients. Investigators also do not know if electrical shocks should be given with the electrode pads on the front (antero-lateral) or front and back (antero-posterior).
Investigators intend to conduct 2 randomized protocols within one study (partial factorial design) in order to answer these two questions. 1. Will initial drug treatment followed by electrical shock if necessary (Drug-Shock) lead to more patients being converted to normal heart rhythm than a strategy of only electrical shock (Shock Only)? 2. Will the antero-posterior pad position be more effective than the antero-lateral position? Investigators plan to enroll 468 RAFF patients at 8 large Canadian EDs. Patients will be randomized to 1 of 2 arms for each of the two protocols. Investigators primary outcome will be conversion to normal heart rhythm. Other outcomes will include heart rhythm at discharge, need for hospital admission, length of stay in ED, adverse events, patient satisfaction, and 14-day follow-up status.
Investigator results will add important information about the best and safest ways to treat RAFF patients in Canadian EDs. Ultimately Investigators expect to see fewer patients admitted to hospital and more patients rapidly and safely returned to their normal activities.
|Condition or disease||Intervention/treatment||Phase|
|Atrial Fibrillation Atrial Flutter||Device: drug-shock vs shock only||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||396 participants|
|Intervention Model:||Factorial Assignment|
|Official Title:||A Randomized, Controlled Comparison of Electrical Versus Pharmacological Cardioversion for Emergency Department Patients With Recent-Onset Atrial Fibrillation and Flutter (RAFF)|
|Actual Study Start Date :||July 18, 2013|
|Actual Primary Completion Date :||October 2018|
|Actual Study Completion Date :||October 31, 2018|
Active Comparator: drug-shock vs shock only
For ED patients with RAFF, Investigators will compare conversion to normal sinus rhythm between the two strategies of i) attempted pharmacological cardioversion with intravenous procainamide followed by DC cardioversion if necessary (Drug-Shock), and ii) DC cardioversion alone (Shock Only).
Device: drug-shock vs shock only
procainamide followed by electrocardioversion if necessary vs cardioversion only.
No Intervention: pad positions
For ED RAFF patients undergoing DC cardioversion, Investigators will compare conversion to normal sinus rhythm between the i) antero-posterior and ii) antero-lateral pad positions.
- conversion to sinus rhythm [ Time Frame: one year ]The primary outcome for both hypotheses will be conversion to sinus rhythm following randomization and maintenance of sinus rhythm for at least 30 minutes. Patients who have not converted by the time 3 DC shocks have been delivered or who revert to AF/AFL during the 30 minutes following the shocks will be considered treatment failures. Spontaneous conversion after randomization but prior to study interventions will be considered a treatment success.
- Outcomes during ED Visit [ Time Frame: 1 day ]Being in normal sinus rhythm at the time of ED disposition
- ED disposition [ Time Frame: 1 day ]ED disposition - admission or discharge;
- Length of stay in ED [ Time Frame: 1 day ]Length of stay in ED in minutes from time of arrival to time of discharge or admission
- Time to conversion to sinus rhythm [ Time Frame: 1 day ]Time to conversion to sinus rhythm in minutes from time of randomization; a 60 minute adjustment will be made for those randomized to placebo infusion.
- Adverse Events [ Time Frame: 1 day ]
i) conduction problems: development of new bundle branch block or QT lengthening >25% from baseline; ii) dysrhythmias: bradycardia (heart rate < 50 bpm), ventricular tachyarrhythmias (torsade de pointes, sustained ventricular tachycardia > 30 seconds, or ventricular fibrillation), or cardiac arrest; iii) hypotension: systolic BP < 90 mm-Hg; iv) respiratory events: hypoxia (O2 saturation < 90%), aspiration, or airway manoeuvres (e.g., jaw positioning, oral airway, BVM ventilation, intubation).
- Physician Comments [ Time Frame: 1 month ]Physician comments on the protocol gathered as narrative by research staff.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01891058
|Foothills Medical Centre|
|Calgary, Alberta, Canada, 2TN 1M7|
|Rockyview General Hospital|
|Calgary, Alberta, Canada|
|University of Alberta Hospital|
|Edmonton, Alberta, Canada, T6G 2B7|
|Canada, British Columbia|
|Vancouver General Hospital|
|Vancouver, British Columbia, Canada, V5Z 1M9|
|Kingston General Hospital|
|Kingston, Ontario, Canada, K7L 2V7|
|Ottawa Hospital Research Institute|
|Ottawa, Ontario, Canada, K1Y 4E9|
|Mount Sinai Hospital|
|Toronto, Ontario, Canada, M5G 1X5|
|Montreal Heart Institute|
|Montreal, Quebec, Canada, H1T 1C8|
|Hopital Du Sacre-Coeur|
|Montreal, Quebec, Canada|
|Hopital de L'Enfant-Jesus|
|Quebec City, Quebec, Canada|
|Principal Investigator:||Ian G Stiell, MD, MSc||Ottawa Hospital Research Institute|