Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Trial of Electrical Versus Pharmacological Cardioversion for RAFF in the ED (RAFF-2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01891058
Recruitment Status : Completed
First Posted : July 2, 2013
Last Update Posted : July 22, 2019
Sponsor:
Collaborator:
The Ottawa Hospital
Information provided by (Responsible Party):
Ottawa Hospital Research Institute

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-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

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 396 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Outcomes during ED Visit [ Time Frame: 1 day ]
    Being in normal sinus rhythm at the time of ED disposition


Other Outcome Measures:
  1. ED disposition [ Time Frame: 1 day ]
    ED disposition - admission or discharge;

  2. 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

  3. 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.

  4. Adverse Events [ Time Frame: 1 day ]

    Adverse events:

    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).


  5. Physician Comments [ Time Frame: 1 month ]
    Physician comments on the protocol gathered as narrative by research staff.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 Criteria:

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:

  1. who are known to have severe heart failure (left ventricular ejection fraction <30% or have clinical or radiological evidence of acute HF);
  2. whose heart rate < 55 bpm;
  3. 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]);
  4. whose ECG shows QTc >460ms;
  5. who have Brugada syndrome (genetic disease with increased risk of sudden cardiac death);
  6. who currently take class I or III antiarrhythmic drugs (last dose < 5 half-lives before enrolment) except Amiodarone;
  7. who have hypersensitivity to procainamide, procaine, other ester-type local anesthetics, or any component of the formulation;
  8. who have had a recent myocardial infarction (< 3 months);
  9. who have these chronic diseases: renal failure (GFR <60 mL/min/1.73m2) or liver disease; or
  10. who are breast feeding or pregnant

Information from the National Library of Medicine

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


Locations
Layout table for location information
Canada, Alberta
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
Canada, Ontario
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
Canada, Quebec
Montreal Heart Institute
Montreal, Quebec, Canada, H1T 1C8
Hopital Du Sacre-Coeur
Montreal, Quebec, Canada
Hopital de L'Enfant-Jesus
Quebec City, Quebec, Canada
Sponsors and Collaborators
Ottawa Hospital Research Institute
The Ottawa Hospital
Investigators
Layout table for investigator information
Principal Investigator: Ian G Stiell, MD, MSc Ottawa Hospital Research Institute

Layout table for additonal information
Responsible Party: Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier: NCT01891058     History of Changes
Other Study ID Numbers: 20130331
G-13-0002756 ( Other Identifier: Heart and Stroke Foundation )
First Posted: July 2, 2013    Key Record Dates
Last Update Posted: July 22, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Atrial Fibrillation
Atrial Flutter
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes