A prospective observational registry study to characterise normal conditions of use, dosing and safety following administration of vernakalant IV sterile concentrate

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Sentinel sites, Observational Study

Study drug and medical condition

• Name of medicine:
  BRINAVESS
• Medical condition to be studied:
  Atrial fibrillation

Population studied

• Short description of the study population:
  Atrial fibrillation patients with vernakalant IV administration.
• Age groups:
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 65 years)

      • Adults (65 to < 75 years)
      • Adults (75 to < 85 years)
      • Adults (85 years and over)
• Special population of interest:
  Other
• Special population of interest, other:
  Atrial fibrillation patients
• Estimated number of subjects:
  2000

Study design details

• Main study objective:
  To collect information about normal use and appropriate dosing and quantify possible medically significant risks associated with the use of vernakalant in real-world clinical practice.
• Outcomes:
  # of participants experiencing: significant hypotenstion, significant ventricular arrhythmia, significant atrial flutter, significant bradycardia, # of participants who are converted to sinus rhythm for at least 1 minute up to 90 minutes after the start of first infusion of vernakalant
• Data analysis plan:
  Frequencies and cumulative incidence of health outcomes of interest (HOIs) and serious adverse events (SAEs) following vernakalant IV administration will be reported for the 24-hour follow-up period, or until end of medical encounter, whichever occurs earlier. Ninety-five percent confidence intervals for the cumulative incidence measures for HOIs will be computed.