Post-operative atrial fibrillation (POAF) MedDRA version: 20.0 Level: PT Classification code 10003658 Term: Atrial fibrillation System Organ Class: 10007541 - Cardiac disorders
Conditions
Sponsors
AbbVie Deutschland GmbH & Co. KG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - 55 to 90 years of age, inclusive, at the time of signing the informed consent - Scheduled to undergo open-chest cardiac surgery. Includes: coronary artery bypass graft (CABG) and/or valve repair/replacement (inclusionary valve repair/replacement procedures for the primary reason for surgery include: aortic or mitral valve repair/replacement; combination of aortic and tricuspid valve repair/replacement; combination of mitral and tricuspid valve repair/replacement; CABG/valve combination procedures [when valvular procedure is one of the 4 sub-bulleted procedures immediately above]; left atrial appendage [LAA] procedures are allowed if CABG and/or valve repair/replacement is the qualifying surgical procedure, but is not a qualifying surgical procedure on its own) - In sinus rhythm for the last 48 hours prior to randomization based on standard-of-care assessments and study ECGs (note: continuous ECG monitoring for 48 hours is not required; prior history of paroxysmal AF is acceptable) - Willing to wear an electrocardiogram (ECG) patch for a full 30 days post-surgery and for 7 days after each study visit Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 130 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 200
Exclusion criteria
Exclusion criteria: • Any medical condition that may put the participant at increased risk with exposure to botulinum toxin type A, including diagnosed muscular dystrophy (eg, Duchenne's muscular dystrophy), myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, mitochondrial disease, or any other significant disease which might interfere with neuromuscular function • Participants with presence or history of any of the following within 3 months prior to the Day 1 visit that may indicate a vulnerable respiratory state per the investigator's clinical judgment: aspiration pneumonia, lower respiratory tract infections, uncontrolled asthma, severe chronic obstructive pulmonary disease or otherwise compromised respiratory function • Permanent/persistent AF • Has a known allergy or sensitivity to any botulinum toxin type A preparation; has a known allergy or sensitivity to medical adhesive (eg, ECG patch adhesive; hydrogel based adhesive) • Severe (> 55mm left atrial diameter) left atrial enlargement • Left ventricular ejection fraction (LVEF) 1st degree within the last 30 days (note: presence of a pacemaker is not exclusionary per se) • Exclusionary valve repair/replacement procedures include combination of aortic and mitral valve repair/replacement; isolated tricuspid valve repair/replacement. • Prior or concomitant therapy with Class I or III antiarrhythmic drugs unless proper washout was documented • Botulinum toxin type A (of any serotype) use within 6 months of randomization • Has been immunized for any botulinum toxin type A serotype as determined by participant medical history • Preoperative need for inotropes/vasopressors or intra-aortic balloon pump • Prior open-chest, sternotomy cardiac surgery • History of ablation for AF • Planned ablation procedure for AF at the time of surgery • Emergency surgery • Impaired prognosis defined as EuroSCORE II > 7% perioperative mortality at screening is exclusionary
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: - To compare the efficacy of AGN-151607 with placebo to prevent post-operative atrial fibrillation (POAF) in participants who are undergoing open chest cardiac surgery - To compare the efficacy of AGN-151607 with placebo to reduce AF burden in participants who are undergoing open-chest cardiac surgery;Secondary Objective: - To compare the efficacy of AGN-151607 with placebo to prevent POAF using alternative definitions for AF in participants who are undergoing open-chest cardiac surgery - To compare the safety of AGN-151607 with placebo in participants undergoing open-chest cardiac surgery ;Primary end point(s): • Percentage of participants with at least 1 continuous atrial fibrillation (AF) episode = 30 seconds during the first 30 days post surgery • Percentage of time spent in AF (AF burden) during the first 30 days post surgery • Percentage of participants with at least 1 event of symptomatic AF during the first 30 days post surgery • Time to first occurrence of AF during the first 30 days post surgery within the first 30 days post surgery;Timepoint(s) of evaluation of this end point: within the first 30 days post surgery | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Percentage of participants with at least 1 continuous AF episode = 2 minutes during the first 30 days post-surgery • Percentage of participants with at least 1 continuous AF episode = 5 minutes during the first 30 days post-surgery • Percentage of participants with at least 1 continuous AF episode = 30 minutes during the first 30 days post-surgery • Percentage of participants with at least 1 continuous AF episode = 1 hour during the first 30 days post surgery • Percentage of participants with at least 1 continuous AF episode = 4 hours during the first 30 days post surgery • Percentage of participants with at least 1 continuous AF episode = 6 hours during the first 30 days post surgery • Percentage of participants with at least 1 continuous AF episode = 12 hours during the first 30 days post surgery • Percentage of participants with at least 1 continuous AF episode = 24 hours during the first 30 days post surgery • Adverse events (AEs), physical examination, clinical laboratory tests, vital signs, electrocardiogram (ECGs), pulmonary function • Potential immunogenicity response;Timepoint(s) of evaluation of this end point: within the first 30 days post surgery | — |
Countries
Austria, Canada, Germany, Italy, Netherlands, Spain, Sweden, United Kingdom, United States
Contacts
Public ContactEU Clinical Trials Helpdesk
AbbVie Ltd.
Outcome results
None listed