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Oral Amiodarone for Acute Cardioversion of Atrial Fibrillation Study

Atrial Fibrillation

The investigators will seek to determine the safety and efficacy of high-dose amiodarone (2000mg), given as a single uniform oral dose, for the treatment of acute atrial fibrillation in both a hospital inpatient and ambulatory outpatient setting. The investigators will conduct a placebo-controlled randomized trial, with outcome ascertainment at 48h.

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Participation Requirements

  • Sex:

    ALL
  • Eligible Ages:

    18 and up

Participation Criteria

Inclusion Criteria:

* Acute persistent or paroxysmal atrial fibrillation or atrial flutter with duration \< 14 days (continuous with no spontaneous conversions), confirmed by ECG or cardiac telemetry
* History of symptoms associated with atrial fibrillation
* Appropriate anticoagulation (warfarin with an international normalized ratio (INR) \> 2.0 or direct oral anticoagulant)

Exclusion Criteria:

* Received \> 10 g of amiodarone in the prior 6 months, or other Class III anti-arrhythmic agents in the prior 3 months
* previous severe adverse event following a cardioversion for atrial fibrillation
* Hypothyroid and not on thyroid replacement therapy
* Recent myocardial infarction (within 2 weeks)
* Acute pulmonary oedema requiring hospital admission or New York Heart Association (NYHA) class IV heart failure
* Severe left ventricular dysfunction or left ventricular ejection fraction \< 36%, as determined by cardiac imaging
* Sick sinus syndrome, high grade atrioventricular block, ventricular rate \< 50 beats per minute in the absence of a mechanical pacemaker
* Severe renal or hepatic disease
* Known congenital long QT syndrome
* Hypotension with systolic blood pressure \< 90 mmHg
* Pregnant or breast-feeding women

Study Location

University of Calgary
University of Calgary
Calgary, Alberta
Canada

Contact Study Team

Primary Contact

Satish R Raj, MD, MSCI

[email protected]
403-210-6152
Backup Contact

Robert S Sheldon, MD, PhD

[email protected]
403-220-8191
Study Sponsored By
University of Calgary
Participants Required
More Information
Study ID: NCT04594746