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

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

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