Botulinum toxin type A (AGN-151607) for the prevention of post operative atrial fibrillation in patients undergoing open-chest cardiac surgery

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 330

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

•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) < 25%; presence or history of symptomatic atrioventricular block > 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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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Updated 9/24/2018