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A Phase 2, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy and Safety of Botulinum Toxin Type A (AGN-151607) Injections Into the Epicardial Fat Pads to Prevent Post-Operative Atrial Fibrillation in Patients Undergoing Open-Chest Cardiac Surgery

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Trial Profile

A Phase 2, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy and Safety of Botulinum Toxin Type A (AGN-151607) Injections Into the Epicardial Fat Pads to Prevent Post-Operative Atrial Fibrillation in Patients Undergoing Open-Chest Cardiac Surgery

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 01 Jul 2024

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At a glance

  • Drugs Botulinum-Toxin-A (Primary)
  • Indications Atrial fibrillation
  • Focus Therapeutic Use
  • Acronyms NOVA
  • Sponsors AbbVie; Allergan

    • Most Recent Events

    • 29 Jun 2024 This trial has been Completed in Italy, according to European Clinical Trials Database record.
    • 13 Nov 2023 Results exploring systemic inflammatory biomarker changes after treatment with BoNT/A and the temporal relation to incidence of POAF, presented at the American Heart Association Scientific Sessions 2023
    • 13 Nov 2023 Results assessing efficacy and pulmonary safety of botulinum toxin type A vs placebo for prevention of POAF after coronary artery bypass graft and/or valve surgery, presented at the American Heart Association Scientific Sessions 2023

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