Expired Study
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Washington, District of Columbia 20010


Purpose:

This is 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.


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 - Written documentation has been obtained in accordance with the relevant country and local privacy requirements, where applicable (eg. Written Authorization for Use and Release of Health and Research Study Information [US sites] and written Data Protection consent (European Union sites). - Participants who are scheduled to undergo open-chest cardiac surgery. Including (coronary artery bypass graft (CABG) and/or valve repair/replacement). - A male participant must agree to use contraception until Day 60 and refrain from donating sperm during this period. - A female participant is eligible to participate if she is not pregnant (has a negative urine pregnancy result prior to randomization) not breastfeeding, and at least 1 of the following conditions applies: 1. Not a woman of childbearing potential (WOCBP). 2. A WOCBP who agrees to follow the contraceptive guidance until after Day 60. - In sinus rhythm for the last 48 hours prior to surgery (prior history of paroxysmal atrial fibrillation (AF) is acceptable). - Willing to wear an electrocardiogram (ECG) patch for 30 days post-surgery and for 7 days after each study visit - Able, as assessed by the investigator, and willing to follow study instructions and likely to complete required study visit. 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 atrial fibrillation (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) atrial enlargement - Left ventricular ejection fraction (LVEF) < 25% - Presence or history of symptomatic atrioventricular block > 1st degree within the last 30 days - 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 cardiac surgery - History of ablation for AF - Planned ablation procedure for AF at the time of surgery - Emergency surgery - Current enrollment in an investigational drug or device study or participation in such a study within 30 days of entry into this study - Impaired prognosis defined as EuroSCORE II greater than 7% perioperative mortality - Females who are pregnant, nursing, or planning a pregnancy during the study


NCT ID:

NCT03779841


Primary Contact:

Study Director
William G Ferguson, PhD
Allergan

Clinical Trials Registry Team
Phone: 877‐277‐8566
Email: IR‐CTRegistration@Allergan.com


Backup Contact:

N/A


Location Contact:

Washington, District of Columbia 20010
United States



There is no listed contact information for this specific location.

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: February 04, 2019

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