Botulinum Toxin Type A (AGN-151607) for the Prevention of Post-operative Atrial Fibrillation in Adult Participants Undergoing Open-chest Cardiac Surgery (NOVA)

Study Identifier
1925-201-008
CT.gov Identifier
EudraCT Identifier
EUCTIS ID
Not available
For general inquiries, please contact
Study Complete

Results Available

Protocol
Available Language(s): English
Statistical Analysis Plan
Available Language(s): English
Plain Language Summary
Available Language(s): English

Study Details

Medical Condition
  • Heart, Blood & Circulatory - Other
  • Study Drug
  • AGN-151607
  • Placebo
  • Phase
    Phase 2
    Sex
    Female & Male
    Age
    55 - 90 Years

    Protocol Summary

    This was a multi-center, randomized, double-blind, placebo-controlled, parallel group, dose-ranging study to evaluate the efficacy and safety of botulinum toxin type A (AGN-151607) injections into the epicardial fat pads, foci of ganglionic plexi, to prevent Post-Operative Atrial Fibrillation (POAF) in patients undergoing open-chest cardiac surgery.

    Study Locations

    Location
    Status
    Location
    Stanford University School of Med /ID# 236922
    Stanford, California, United States, 94305-2200
    Status
    Not applicable
    Location
    Yale New Haven Hospital - Yale School of Medicine /ID# 238221
    New Haven, Connecticut, United States, 06510-3206
    Status
    Not applicable
    Location
    Medstar Washington Hospital Center /ID# 234322
    Washington D.C., District of Columbia, United States, 20010-3017
    Status
    Not applicable
    Location
    Emory Saint Joseph's Hospital /ID# 234334
    Atlanta, Georgia, United States, 30342-1731
    Status
    Not applicable
    Location
    Lutheran Medical Group /ID# 237990
    Fort Wayne, Indiana, United States, 46804
    Status
    Not applicable
    Location
    Ochsner Medical Center /ID# 238004
    New Orleans, Louisiana, United States, 70121-2429
    Status
    Not applicable
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