Effectiveness, safety and efficiency of the use of vernakalant in the control of the rhythm of atrial fibrillation in the emergency. Cohort study (VERITA)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/103552
• EU PAS number:
  EUPAS103551
• Study ID:
  103552
• Official title and acronym:
  Effectiveness, safety and efficiency of the use of vernakalant in the control of the rhythm of atrial fibrillation in the emergency. Cohort study (VERITA)
• DARWIN EU® study:
  No
• Study countries:
  Spain
• Study description:
  Atrial fibrillation (AF) is the most prevalent sustained arrhythmia in clinical practice in hospital emergency departments. Complications of AF include thromboembolism and heart failure. In addition, affected patients may be at increased risk of mortality. Within the acute management of AF, two different strategies should be considered: rate control (usually with a beta-blocker or calcium channel inhibitor) and rhythm control (electrical or pharmacological cardioversion). Rhythm and rate control strategies are associated with similar rates of mortality and morbidity, such as embolic risk. The decision to adopt a therapeutic strategy is usually dictated by the presence of symptoms associated with AF and/or the development of left ventricular systolic dysfunction believed to be secondary to the arrhythmia. According to the ESC guidelines, there are different options for pharmacological cardioversion: flecainide and propafenone (class Ic antiarrhythmics), intravenous amiodarone, and vernakalant. Other alternatives, such as dofetilide and ibutilide, are not marketed in Europe. On June 24, 2010, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion, recommending the marketing authorization of vernakalant, indicated for the rapid conversion to sinus rhythm of AF. of recent onset in adults. For its part, the United States Food and Drug Administration (FDA) denied the marketing application for vernakalant due to safety concerns: severe hypotension, ventricular arrhythmias, conduction abnormalities, and death. Currently, the management in terms of AF rhythm control in emergency services varies depending on the idiosyncrasy of each hospital and its own experience of use. In this context, a retrospective observational study is proposed to evaluate the efficiency and safety of vernakalant in clinical practice.
• Study status:
  Finalised

Research institutions and networks

Institutions

Puerta de Hierro-Majadahonda University Hospital

Study timelines

Date when funding contract was signed

Planned: 06/06/2022

Actual: 06/06/2022

Study start date

Planned: 01/09/2022

Actual: 01/09/2022

Data analysis start date

Planned: 31/10/2023

Actual: 14/02/2023

Date of interim report, if expected

Planned: 29/12/2023

Actual: 14/02/2023

Date of final study report

Planned: 01/06/2024

Actual: 14/02/2023

Sources of funding

Other

More details on funding

The study is not funded

Study protocol

Initial protocol

PROTOCOLO ESTUDIO VERNAKALANT EN URGENCIAS VERSION 25052022

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable