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Botulinum Toxin Type A (AGN-151607) for the Prevention of Post-operative Atrial Fibrillation in Patients Undergoing Open-chest Cardiac Surgery (NOVA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03779841
Recruitment Status : Recruiting
First Posted : December 19, 2018
Last Update Posted : December 20, 2019
Sponsor:
Information provided by (Responsible Party):
Allergan

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Post-Operative Atrial Fibrillation Drug: AGN-151607 Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 330 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 2, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy and Safety of Botulinum Toxin Type A (AGN-151607) Injections Into the Epicardial Fat Pads to Prevent Post-Operative Atrial Fibrillation in Patients Undergoing Open-Chest Cardiac Surgery
Actual Study Start Date : March 1, 2019
Estimated Primary Completion Date : October 15, 2020
Estimated Study Completion Date : October 14, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: AGN-151607 (250 U)
Injections of 50 U will be made into each 1 of 5 fat pads. The total injection volume into each fat pad will be 1 mL. One-time treatment.
Drug: AGN-151607
Injections will be made into each 1 of 5 fat pads. The total injection volume into each fat pad will be 1 mL. One-time treatment.

Experimental: AGN-151607 (125 U)
Injections of 25 U will be made into each 1 of 5 fat pads. The total injection volume into each fat pad will be 1 mL. One-time treatment.
Drug: AGN-151607
Injections will be made into each 1 of 5 fat pads. The total injection volume into each fat pad will be 1 mL. One-time treatment.

Placebo Comparator: Placebo
Injections of placebo will be made into each 1 of 5 fat pads. The total injection volume into each fat pad will be 1 mL. One-time treatment.
Drug: Placebo
Injections of placebo will be made into each 1 of 5 fat pads. The total injection volume into each fat pad will be 1 mL. One-time treatment.




Primary Outcome Measures :
  1. Percentage of participants with at least 1 continuous atrial fibrillation (AF) episode ≥ 30 seconds during the first 30 days post-surgery. [ Time Frame: 30 days ]

Secondary Outcome Measures :
  1. Percentage of time spent in AF (AF burden) during the first 30 days post-surgery [ Time Frame: 30 days ]
  2. Percentage of participants with at least 1 event of symptomatic AF during the first 30 days post-surgery [ Time Frame: 30 days ]
  3. Time to first occurrence of AF during the first 30 days post-surgery [ Time Frame: 30 days ]
  4. Percentage of participants with at least 1 continuous AF episode ≥ 2 minutes during the first 30 days post-surgery [ Time Frame: 30 days ]
  5. Percentage of participants with at least 1 continuous AF episode ≥ 5 minutes during the first 30 days post-surgery [ Time Frame: 30 days ]
  6. Percentage of participants with at least 1 continuous AF episode ≥ 30 minutes during the first 30 days post-surgery [ Time Frame: 30 days ]
  7. Percentage of participants with at least 1 continuous AF episode ≥ 1 hour during the first 30 days post-surgery [ Time Frame: 30 days ]
  8. Percentage of participants with at least 1 continuous AF episode ≥ 4 hours during the first 30 days post-surgery [ Time Frame: 30 days ]
  9. Percentage of participants with at least 1 continuous AF episode ≥ 24 hours during the first 30 days post-surgery [ Time Frame: 30 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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:
  • Not a woman of childbearing potential (WOCBP).
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03779841


Contacts
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Contact: Clinical Trials Registry Team 877‐277‐8566 IR‐CTRegistration@Allergan.com

Locations
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Sponsors and Collaborators
Allergan
Investigators
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Study Director: William G Ferguson, PhD Allergan

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Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT03779841    
Other Study ID Numbers: 1925-201-008
2017-004399-68 ( EudraCT Number )
First Posted: December 19, 2018    Key Record Dates
Last Update Posted: December 20, 2019
Last Verified: December 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Botulinum Toxins
Botulinum Toxins, Type A
abobotulinumtoxinA
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents