NCT03779841

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

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: Phase 2
• Study type: Interventional
• Enrollment: 323 (actual)
• Sponsor: AbbVie · Industry
• Sex: All
• Age: 55 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Post-Operative Atrial Fibrillation

Interventions

Type	Name	Description
DRUG	AGN-151607	Injections were made into each 1 of 5 fat pads. The total injection volume into each fat pad was 1 mL. One-time treatment.
DRUG	Placebo	Injections of placebo were made into each 1 of 5 fat pads. The total injection volume into each fat pad was 1 mL. One-time treatment.

Timeline

• Start date: 2019-03-01
• Primary completion: 2022-03-24
• Completion: 2023-03-06
• First posted: 2018-12-19
• Last updated: 2024-05-14
• Results posted: 2024-05-14

Locations

32 sites across 9 countries: United States, Austria, Canada, Germany, Italy, Netherlands, Spain, Sweden, United Kingdom

Regulatory

• FDA-regulated drug study