Trial of Electrical Versus Pharmacological Cardioversion for RAFF in the ED

NCT01891058 | Completed DMC

• 2 other identifiers: 20130331G-13-0002756
• Study Type: interventional
• Target: 396
• Locations: 1 country
• Sites: 10

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.

Conditions

Atrial Fibrillation; Atrial Flutter

Outcome Measures

Primary Outcomes (1)

• conversion to sinus rhythm

  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.

  one year

Secondary Outcomes (1)

• Outcomes during ED Visit

  1 day

Other Outcomes (5)

• ED disposition

  1 day

• Length of stay in ED

  1 day

• Time to conversion to sinus rhythm

  1 day

Study Arms (2)

drug-shock vs shock only

ACTIVE COMPARATOR

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

pad positions

NO INTERVENTION

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.

Interventions

drug-shock vs shock only DEVICE

procainamide followed by electrocardioversion if necessary vs cardioversion only.

drug-shock vs shock only

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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;

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead
• The Ottawa Hospital: collaborator

Study Sites (10)

Foothills Medical Centre

Calgary, Alberta, 2TN 1M7, Canada

Location

Rockyview General Hospital

Calgary, Alberta, Canada

Location

University of Alberta Hospital

Edmonton, Alberta, T6G 2B7, Canada

Location

Vancouver General Hospital

Vancouver, British Columbia, V5Z 1M9, Canada

Location

Kingston General Hospital

Kingston, Ontario, K7L 2V7, Canada

Location

Ottawa Hospital Research Institute

Ottawa, Ontario, K1Y 4E9, Canada

Location

Mount Sinai Hospital

Toronto, Ontario, M5G 1X5, Canada

Location

Montreal Heart Institute

Montreal, Quebec, H1T 1C8, Canada

Location

Hopital Du Sacre-Coeur

Montreal, Quebec, Canada

Location

Hopital de L'Enfant-Jesus

Québec, Quebec, Canada

Location

Related Publications (2)

• Stiell IG, Sivilotti MLA, Taljaard M, Birnie D, Vadeboncoeur A, Hohl CM, McRae AD, Morris J, Mercier E, Macle L, Brison RJ, Thiruganasambandamoorthy V, Rowe BH, Borgundvaag B, Clement CM, Brinkhurst J, Brown E, Nemnom MJ, Wells GA, Perry JJ. A randomized, controlled comparison of electrical versus pharmacological cardioversion for emergency department patients with acute atrial flutter. CJEM. 2021 May;23(3):314-324. doi: 10.1007/s43678-020-00067-7. Epub 2021 Jan 18.

  PMID: 33959925 DERIVED

• Stiell IG, Sivilotti MLA, Taljaard M, Birnie D, Vadeboncoeur A, Hohl CM, McRae AD, Rowe BH, Brison RJ, Thiruganasambandamoorthy V, Macle L, Borgundvaag B, Morris J, Mercier E, Clement CM, Brinkhurst J, Sheehan C, Brown E, Nemnom MJ, Wells GA, Perry JJ. Electrical versus pharmacological cardioversion for emergency department patients with acute atrial fibrillation (RAFF2): a partial factorial randomised trial. Lancet. 2020 Feb 1;395(10221):339-349. doi: 10.1016/S0140-6736(19)32994-0.

  PMID: 32007169 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation; Atrial Flutter

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ian G Stiell, MD, MSc

  Ottawa Hospital Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2013
• First Posted: July 2, 2013
• Study Start: July 18, 2013
• Primary Completion: October 1, 2018
• Study Completion: October 31, 2018
• Last Updated: July 22, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (10)