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Trial · NCT04485195

Registered outcomes13

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryConversion to sinus rhythm for a minimum duration of 30 minutesDuring any time following randomization until 30 minutes past the completion of the drug infusion
Conversion to and maintenance of sinus rhythm for at least 30 minutes at any time following randomization until 30 minutes past the completion of the drug infusion. Heart rhythm will be determined by an electrocardiogram (ECG).
SecondaryNormal sinus rhythmAt the time of patient disposition (approximately 3 hours after arrival)Being in normal sinus rhythm at the time of ED disposition (discharge or admission). Heart rhythm will be determined by an electrocardiogram (ECG).
SecondaryPatient disposition (admission or discharge)At the time of patient admission or discharge (approximately 3 hours after arrival)Whether the patient was discharged home or admitted to the hospital.
SecondaryLength of stay in EDFrom time of arrival until time of discharge or admission (approximately 3 hours)Length of stay in ED in minutes, from time of arrival to time of discharge or admission
SecondaryTime to dischargeFrom time of randomization until time of discharge or admission (approximately 3 hours)Time to discharge in minutes, from time of randomization to time of discharge or admission
SecondaryTime to conversionFrom time of infusion start until time of conversion to sinus rhythm (approximately 0 - 90 minutes)Time to conversion to sinus rhythm in minutes, from time of start of study drug infusion
SecondaryWhether the patient required electrical cardioversionFrom 30 minutes after the study drug infusion is completed.Whether the patient required electrical cardioversion to restore normal sinus rhythm in the ED
SecondaryAdverse events0-12 hourswill be classified as serious or other, whether occurring 0-2 hours or 2-12 hours after infusion, whether infusion had to be halted or discontinued, or treatment required
OtherMaintenance of normal sinus rhythm30 days post dischargeMaintenance of normal sinus rhythm at 30 days after ED disposition, to be verified by hospital records, patient report, or by a smartphone application.
OtherRecurrence of acute AF30 daysRecurrence of acute atrial fibrillation requiring an emergency department visit
OtherDeath30 dayswithin 30 days of ED disposition
OtherStroke30 daystransient ischemic attack, myocardial infarction, or other thromboembolic event within 30 days of ED disposition
OtherReturn to normal activities30 daysReturn to normal daily activities measured in days

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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