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Vernakalant Versus Amiodarone for Post-operative Atrial Fibrillation in Cardiac Surgery Patients

StatusNot Yet Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Notable Primary completion date: Jan 2025 to Jan 2028
    • Start date: Sep 2024 to Sep 2026
    • Study completion date: Sep 2025 to Sep 2029
    v8
  2. Notable Start date: Jan 2024 to Sep 2024v7
  3. Notable Primary completion date: Jan 2024 to Jan 2025
    • Start date: Jan 2023 to Jan 2024
    • Study completion date: Sep 2024 to Sep 2025
    v6
  4. Notable Start date: Sep 2022 to Jan 2023
    • Primary completion date: Sep 2023 to Jan 2024
    • Study completion date: Sep 2023 to Sep 2024
    v5
  5. Notable Primary completion date: Jan 2023 to Sep 2023
    • Start date: Jan 2022 to Sep 2022
    • Study completion date: Aug 2023 to Sep 2023
    v4
Show 2 earlier versionsHide 2 earlier versions
  1. Notable Start date: Jul 2021 to Jan 2022
    • Primary completion date: Jul 2022 to Jan 2023
    • Study completion date: Aug 2022 to Aug 2023
    v3
  2. Notable Start date: Mar 2021 to Jul 2021
    • Primary completion date: Mar 2022 to Jul 2022
    • Study completion date: Jun 2022 to Aug 2022
    v2
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Post-operative atrial fibrillation is a common problem post cardiac surgery with rates exceeding 30%. Atrial fibrillation has multiple adverse effects on cardiac hemodynamics and can lead to hypotension, diminished end organ perfusion and lengthen the stay in ICU. Amiodarone is the medication of choice used for pharmacological cardioversion and can be used with vasoactive medications. Intravenous amiodarone is associated with hypotension and end organ perfusion requiring escalation in vasoactive support. Vernakalant is novel anti-arrhythmic agent approved in Canada for cardioversion of atrial fibrillation that primarily works on atrial channels and has no effect on contractility or vasodilation. Clinical trials have proved good efficacy of Vernakalant in conversion of paroxysmal atrial fibrillation however there is no comparison of Amiodarone to Vernakalant in post-operative cardiac surgery. We plan to perform a clinical trial comparing Vernakalant to amiodarone in post-cardiac surgery patients with a primary outcome of cardioversion at 90 minutes. Secondary outcomes will follow duration of vasoactive medications, days in ICU and economics.
Trial Details
NCT Number NCT04748991
Lead Sponsor University of Calgary
Conditions
(from sponsor)
Atrial Fibrillation, Post-cardiac Surgery
Related terms Atrial Fibrillation
Enrollment 50 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov