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Completed

NCT Number: NCT01461733

Atrial Fibrillation Without Hemodynamic Instability in the Intensive Care Unit

Atrial fibrillation (AF) is an abnormal heart rhythm that is common among patients who are admitted to an intensive care unit (ICU) of a hospital. It is usually a transient occurrence that resolves as the patient recovers from their underlying condition. However, patients who develop AF can present with a very rapid heart rate that in some cases can put stress on the heart which can lead to life threatening heart attacks, low blood pressure or breathing problems. Not all patients with AF will have unstable heart function but those who have rapid heart rates can worsen quickly. The goals of treatment for AF with a rapid heart rate but no unstable heart function are two fold. Patients can be treated by controlling the heart rate and/or by attempting to convert the AF to a normal heart rhythm. The heart rate can be controlled by medication and the AF can be converted by either electrical cardioversion (an electric shock that jump-starts the heart) or medication. Currently it is unknown if the goal of treatment should be to simply control the heart rate and wait for the patient to spontaneously convert to a normal heart rhythm or convert the AF with medication for patients who only have the rapid heart rate.

The objective of this project is to conduct a pilot study to determine if it would be feasible to conduct a larger definitive trial that would answer the following question: Should the goal of treatment be to control the rapid heart rate or resolve the abnormal heart rhythm in patients with AF who have a rapid heart rate without unstable heart function.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

see above

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • new onset afib

Exclusion criteria

  • hemodynamically unstable

Treatment and study plan

Amiodarone

Drug

standard dose amiodarone

Other names: non applicable

Placebo

Drug

placebo delivered blinded

Primary outcomes

  1. Conversion From Atrial Fibrillation to Sinus Rhythm

    Time frame: From randomization to conversion or ICU discharge up to 100 months.

    Conversion rates measured during ICU stay only. Average duration of ICU stay is 7 days.

Sponsors and collaborators

Lead sponsor

Ottawa Hospital Research Institute

Other

Collaborators

  • Heart and Stroke Foundation of Ontario

Registry information

Official study title

Atrial Fibrillation WITHOUT Hemodynamic Stability

Acronym: AFIB

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Oct 28, 2011
Registry last updated
Sep 15, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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