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Trial · NCT04485195

RAFF4 Trial: Vernakalant vs. Procainamide for Acute Atrial Fibrillation in the Emergency Department

NCT04485195, Phase 4, Completed, Ottawa Hospital Research Institute

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. RAFF4 Trial: Vernakalant vs. Procainamide for Acute Atrial Fibrillation in the Emergency Department. Trials, record NCT04485195. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04485195

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
RAFF4 Trial: Vernakalant vs. Procainamide for Acute Atrial Fibrillation in the Emergency Department
NCT number
NCT04485195
Status
Completed
Phases
Phase 4
Enrollment
350 participants, actual
Lead sponsor
Ottawa Hospital Research Institute
Conditions
Atrial Fibrillation
Interventions
Vernakalant, Procainamide
First posted
2020-07-24
Last updated
2025-04-10

Source ClinicalTrials.gov

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

Outcomes0

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

None in this release.

Results by group0

Each measurement the trial posted, group by group, in the words and numbers it posted.

None in this release.

Participant flow0

How many started, completed or left each group, period by period.

None in this release.

Adverse events0

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

None in this release.

Adverse event totals0

The totals the trial posted for each group.

None in this release.

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMIDListed as
41218981DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

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.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT04485195

GET https://conductscience.org/api/trials/v1/NCT04485195/registered