Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03779841 | Botulinum Toxin Type A (AGN-151607) for the Prevention of Post-operative Atrial Fibrillation in Adult Participants Undergoing Open-chest Cardiac Surgery (NOVA) | PHASE2 | COMPLETED | 323 | — | — | Mar 1, 2019 | Mar 6, 2023 | May 14, 2024 | 32 | United States, Austria +7 |
At least one episode of continuous AF (atrial fibrillation or atrial flutter) sustained ≥ 30 seconds documented by monitoring ECG measurements using ECG patches (ePatch) placed on the participant's chest.
| Arm | Type | Description |
|---|---|---|
| AGN-151607 (250 U) | EXPERIMENTAL | Injections of 50 U were made into each 1 of 5 fat pads. The total injection volume into each fat pad was 1 mL. One-time treatment. |
| AGN-151607 (125 U) | EXPERIMENTAL | Injections of 25 U were made into each 1 of 5 fat pads. The total injection volume into each fat pad was 1 mL. One-time treatment. |
| Placebo | PLACEBO_COMPARATOR | 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. |
| Name | Type | Description |
|---|---|---|
| AGN-151607 | DRUG | Injections were made into each 1 of 5 fat pads. The total injection volume into each fat pad was 1 mL. One-time treatment. |
| Placebo | DRUG | 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. |
Inclusion Criteria: Inclusion Criteria: * Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form. * Written informed consent from the participant has been obtained prior to any study-related procedures * Writt...