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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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03779841
Recruitment Status : Active, not recruiting
First Posted : December 19, 2018
Last Update Posted : April 11, 2022
Sponsor:
Information provided by (Responsible Party):
AbbVie

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)
Actual 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
Actual Primary Completion Date : March 24, 2022
Estimated Study Completion Date : February 27, 2023

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 ]
  10. Percentage of participants with at least 1 continuous AF episode ≥ 6 hours during the first 30 days post-surgery [ Time Frame: 30 days ]
  11. Percentage of participants with at least 1 continuous AF episode ≥ 12 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:

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. Includes: coronary artery bypass graft (CABG) and/or valve repair/replacement. Inclusionary valve repair/replacement procedures for the primary reason for surgery include: Aortic valve repair/replacement, 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 or replacement is the qualifying surgical procedure, but is not a qualifying surgical procedure on its own.
  • 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 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
  • Able, as assessed by the investigator, and willing to follow study instructions and likely to complete required study visit.

Exclusion Criteria:

  • Any uncontrolled clinically significant medical condition other than the one under study that, in the investigator's opinion, would put the participant at an unacceptable risk with exposure to botulinum toxin type A.
  • Exclusionary valve repair/replacement procedures include: Combination of aortic and mitral valve repair/replacement, Isolated tricuspid valve repair/replacement.
  • 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 (> 55 mm 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) - 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
  • Current enrollment in an investigational drug or device study or participation in such a study within 30 days of entry into this study
  • Participants have diagnostic assessments which in the opinion of the investigator prevent participation in the study
  • Impaired prognosis defined as EuroSCORE II > 7% perioperative mortality at screening is exclusionary.
  • Females who are pregnant, nursing, or planning a pregnancy during the study
  • The participant has a condition or is in a situation which, in the investigator's opinion, may put the participant at significant risk, may confound the study results, or may interfere significantly with the participant's participation in 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


Locations
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Sponsors and Collaborators
AbbVie
Investigators
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Study Director: ALLERGAN INC. Allergan
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: AbbVie
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: April 11, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
Access Criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.
URL: https://vivli.org/ourmember/abbvie/

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes