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Trial of Electrical Versus Pharmacological Cardioversion for RAFF in the ED

NCT01891058 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 396

Last updated 2019-07-22

No results posted yet for this study

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

Interventions

DEVICE

drug-shock vs shock only

procainamide followed by electrocardioversion if necessary vs cardioversion only.

Sponsors & Collaborators

  • The Ottawa Hospital

    collaborator OTHER

  • Ottawa Hospital Research Institute

    lead OTHER

Principal Investigators

  • Ian G Stiell, MD, MSc · Ottawa Hospital Research Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
FACTORIAL

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-07-18
Primary Completion
2018-10-31
Completion
2018-10-31

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01891058 on ClinicalTrials.gov