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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 : March 31, 2020
Sponsor:
Information provided by (Responsible Party):
Allergan

Tracking Information
First Submitted Date  ICMJE December 17, 2018
First Posted Date  ICMJE December 19, 2018
Last Update Posted Date March 31, 2020
Actual Study Start Date  ICMJE March 1, 2019
Estimated Primary Completion Date October 15, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 17, 2018)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 17, 2018)
  • Percentage of time spent in AF (AF burden) during the first 30 days post-surgery [ Time Frame: 30 days ]
  • Percentage of participants with at least 1 event of symptomatic AF during the first 30 days post-surgery [ Time Frame: 30 days ]
  • Time to first occurrence of AF during the first 30 days post-surgery [ Time Frame: 30 days ]
  • Percentage of participants with at least 1 continuous AF episode ≥ 2 minutes during the first 30 days post-surgery [ Time Frame: 30 days ]
  • Percentage of participants with at least 1 continuous AF episode ≥ 5 minutes during the first 30 days post-surgery [ Time Frame: 30 days ]
  • Percentage of participants with at least 1 continuous AF episode ≥ 30 minutes during the first 30 days post-surgery [ Time Frame: 30 days ]
  • Percentage of participants with at least 1 continuous AF episode ≥ 1 hour during the first 30 days post-surgery [ Time Frame: 30 days ]
  • Percentage of participants with at least 1 continuous AF episode ≥ 4 hours during the first 30 days post-surgery [ Time Frame: 30 days ]
  • Percentage of participants with at least 1 continuous AF episode ≥ 24 hours during the first 30 days post-surgery [ Time Frame: 30 days ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Botulinum Toxin Type A (AGN-151607) for the Prevention of Post-operative Atrial Fibrillation in Patients Undergoing Open-chest Cardiac Surgery (NOVA)
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Post-Operative Atrial Fibrillation
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • 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.
    Intervention: Drug: AGN-151607
  • 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.
    Intervention: Drug: AGN-151607
  • 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.
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 17, 2018)
330
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 14, 2021
Estimated Primary Completion Date October 15, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 55 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Clinical Trials Registry Team 877‐277‐8566 IR‐CTRegistration@Allergan.com
Listed Location Countries  ICMJE Austria,   Canada,   Germany,   Italy,   Netherlands,   Spain,   Sweden,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03779841
Other Study ID Numbers  ICMJE 1925-201-008
2017-004399-68 ( EudraCT Number )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Allergan
Study Sponsor  ICMJE Allergan
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: William G Ferguson, PhD Allergan
PRS Account Allergan
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP