Post-Operative Atrial FibrillationPhase 2NCT03779841
Botulinum Toxin Type A (AGN-151607) for the Prevention of Post-operative Atrial Fibrillation in Adult Participants Undergoing Open-chest Cardiac Surgery (NOVA)
A Phase 2 study testing AGN-151607 in people with Post-Operative Atrial Fibrillation, run by AbbVie at 32 sites in 9 countries.
Trial summary
This was 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… Read more about this study
- Who is it for?
- Ages 55 to 90 years
- Conditions the study is for
- Post-Operative Atrial Fibrillation
- What is being tested?
- AGN-151607
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 323 participants
- Where
- 32 sitesin 9 countries
- Study dates
- 1 Mar 2019to 6 Mar 2023
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
32 sites in 9 countries.
32 sites in 9 countries
United States19 sites
University of Michigan /ID# 236228
Ann Arbor, Michigan, 48109-5000
Mission Hospital /ID# 237231
Asheville, North Carolina, 28801
Emory Saint Joseph's Hospital /ID# 234334
Atlanta, Georgia, 30342-1731
University of Maryland Medical Center /ID# 234352
Baltimore, Maryland, 21201-1544
Medical University of South Carolina /ID# 236476
Charleston, South Carolina, 29425
University of Virginia /ID# 237611
Charlottesville, Virginia, 22908
Ohio State University Medical Center /ID# 234408
Columbus, Ohio, 43210
Duke University Medical Center /ID# 234314
Durham, North Carolina, 27705-4410
Lutheran Medical Group /ID# 237990
Fort Wayne, Indiana, 46804
East Carolina University /ID# 237820
Greenville, North Carolina, 27858
Dartmouth-Hitchcock Medical Center /ID# 237530
Lebanon, New Hampshire, 03756
Yale New Haven Hospital - Yale School of Medicine /ID# 238221
New Haven, Connecticut, 06510-3206
Ochsner Medical Center /ID# 238004
New Orleans, Louisiana, 70121-2429
Icahn School of Medicine at Mount Sinai - The Mount Sinai Medical Center /ID# 234449
New York, New York, 10029
Baylor Scott & White Research Institute /ID# 235937
Plano, Texas, 75093
University of Utah /ID# 237601
Salt Lake City, Utah, 84112-5500
Washington University-School of Medicine /ID# 238121
St Louis, Missouri, 63110
Stanford University School of Med /ID# 236922
Stanford, California, 94305-2200
Medstar Washington Hospital Center /ID# 234322
Washington D.C., District of Columbia, 20010-3017
Canada6 sites
Montreal Heart Insitute /ID# 234859
Montreal, Quebec, H1T 1C8
CHUM - Centre hospitalier de l'Universite de Montréal /ID# 238163
Montreal, Quebec, H2X 3E4
CIUSSS du Nord-de-l'ile-de-Montréal_Hopital du Sacré-Coeur de Montréal /ID# 234316
Montreal, Quebec, H4J 1C5
University of Ottawa Heart Institute /ID# 236012
Ottawa, Ontario, K1Y 4W7
Institut universitaire de cardiologie et de pneumologie de Québec - Université L /ID# 237166
Québec, Quebec, G1V 4G5
Toronto General Hospital /ID# 237680
Toronto, Ontario, M5G 2C4
Austria1 site
Medizinische Universitaet Wien /ID# 238259
Vienna, State of Vienna, 1090
Netherlands1 site
Academisch Medisch Centrum /ID# 237113
Amsterdam, 1105 AZ
Spain1 site
Hospital Clínic. University of Barcelona /ID# 234853
Barcelona, 08039
Sweden1 site
Orebro University Hospital Sweden /ID# 236047
Örebro, Örebro County, 702 12
United Kingdom1 site
University Hospital Plymouth NHS Trust /ID# 234423
Plymouth, PL6 5FP
About this study
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
This was 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.
- Conditions
- Post-Operative Atrial Fibrillation
- Being tested
- AGN-151607, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AGN-151607Drug
Injections were made into each 1 of 5 fat pads. The total injection volume into each fat pad was 1 mL. One-time treatment.
PlaceboDrug
Injections of placebo were made into each 1 of 5 fat pads. The total injection volume into each fat pad was 1 mL. One-time treatment.
| Study group | Role | What they receive |
|---|---|---|
| AGN-151607 (250 U) | Experimental | Injections of 50 U were made into each 1 of 5 fat pads. The total injection volume into each fat pad was 1 mL. One-time treatment. Receives: Drug: AGN-151607 |
| AGN-151607 (125 U) | Experimental | Injections of 25 U were made into each 1 of 5 fat pads. The total injection volume into each fat pad was 1 mL. One-time treatment. Receives: Drug: AGN-151607 |
| Placebo | Placebo comparator | Injections of placebo were made into each 1 of 5 fat pads. The total injection volume into each fat pad was 1 mL. One-time treatment. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With at Least 1 Continuous AF (Atrial Fibrillation or Atrial Flutter) Episode ≥ 30 Seconds During the First 30 Days Post-surgery
At least one episode of continuous AF (atrial fibrillation or atrial flutter) sustained ≥ 30 seconds documented by monitoring ECG measurements using ECG patches (ePatch) placed on the participant's chest.
Measured: First 30 days following the initial intensive care unit (ICU) admission date after open-chest cardiac surgery.
Secondary outcomes (16)
Percentage of Time Spent in Atrial Fibrillation or Atrial Flutter (AF Burden) During the First 30 Days Post-surgery
The proportion of time an individual is in AF (atrial fibrillation or atrial flutter) during a monitoring period (expressed as a percentage) calculated as (the total time spent in AF during the first 30 days post-surgery divided by the total time of analyzable data obtained from the ECG patch during the first 30 days post-surgery) multiplied by 100. The calculation excludes continuous AF episodes < 30 seconds in duration.
Measured: First 30 days following the initial ICU admission date after open-chest cardiac surgery.
Percentage of Participants With at Least 1 Event of Symptomatic AF (Atrial Fibrillation or Atrial Flutter) During the First 30 Days Post-surgery
At least 1 event of symptomatic AF (atrial fibrillation or atrial flutter) (symptoms occurring within 2 hours of an AF episode). For symptomatic AF, symptoms that occur in the interval that starts two hours prior to the onset of the AF episode and ends two hours after the conclusion of the AF episode will meet the definition of "within 2 hours of an AF episode".
AF episode ≥ 30 seconds.
Measured: First 30 days following the initial ICU admission date after open-chest cardiac surgery.
Time to First Occurrence of AF (Atrial Fibrillation or Atrial Flutter) During the First 30 Days Post-surgery
Amount of time (days) to first AF (atrial fibrillation or atrial flutter) occurrence defined by first episode of AF lasting for ≥ 30 seconds.
Measured: First 30 days following the initial ICU admission date after open-chest cardiac surgery.
Percentage of Participants With at Least 1 Continuous AF (Atrial Fibrillation or Atrial Flutter) Episode ≥ 2 Minutes During the First 30 Days Post-surgery
At least one episode of continuous AF (atrial fibrillation or atrial flutter) sustained ≥ 2 minutes documented by monitoring ECG measurements using ECG patches (ePatch) placed on the participant's chest.
Measured: First 30 days following the initial ICU admission date after open-chest cardiac surgery.
Percentage of Participants With at Least 1 Continuous AF (Atrial Fibrillation or Atrial Flutter) Episode ≥ 5 Minutes During the First 30 Days Post-surgery
At least one episode of continuous AF (atrial fibrillation or atrial flutter) sustained ≥ 5 minutes documented by monitoring ECG measurements using ECG patches (ePatch) placed on the participant's chest.
Measured: First 30 days following the initial ICU admission date after open-chest cardiac surgery.
Percentage of Participants With at Least 1 Continuous AF (Atrial Fibrillation or Atrial Flutter) Episode ≥ 6 Minutes During the First 30 Days Post-surgery
At least one episode of continuous AF (atrial fibrillation or atrial flutter) sustained ≥ 6 minutes documented by monitoring ECG measurements using ECG patches (ePatch) placed on the participant's chest.
Measured: First 30 days following the initial ICU admission date after open-chest cardiac surgery.
Percentage of Participants With at Least 1 Continuous AF (Atrial Fibrillation or Atrial Flutter) Episode ≥ 30 Minutes During the First 30 Days Post-surgery
At least one episode of continuous AF (atrial fibrillation or atrial flutter) sustained ≥ 30 minutes documented by monitoring ECG measurements using ECG patches (ePatch) placed on the participant's chest.
Measured: First 30 days following the initial ICU admission date after open-chest cardiac surgery.
Percentage of Participants With at Least 1 Continuous AF (Atrial Fibrillation or Atrial Flutter) Episode ≥ 1 Hour During the First 30 Days Post-surgery
At least one episode of continuous AF (atrial fibrillation or atrial flutter) sustained ≥ 1 hour documented by monitoring ECG measurements using ECG patches (ePatch) placed on the participant's chest.
Measured: First 30 days following the initial ICU admission date after open-chest cardiac surgery.
Percentage of Participants With at Least 1 Continuous AF (Atrial Fibrillation or Atrial Flutter) Episode ≥ 4 Hours During the First 30 Days Post-surgery
At least one episode of continuous AF (atrial fibrillation or atrial flutter) sustained ≥ 4 hours documented by monitoring ECG measurements using ECG patches (ePatch) placed on the participant's chest.
Measured: First 30 days following the initial ICU admission date after open-chest cardiac surgery.
Percentage of Participants With at Least 1 Continuous AF (Atrial Fibrillation or Atrial Flutter) Episode ≥ 6 Hours During the First 30 Days Post-surgery
At least one episode of continuous AF (atrial fibrillation or atrial flutter) sustained ≥ 6 hours documented by monitoring ECG measurements using ECG patches (ePatch) placed on the participant's chest.
Measured: First 30 days following the initial ICU admission date after open-chest cardiac surgery.
Percentage of Participants With at Least 1 Continuous AF (Atrial Fibrillation or Atrial Flutter) Episode ≥ 12 Hours During the First 30 Days Post-surgery
At least one episode of continuous AF (atrial fibrillation or atrial flutter) sustained ≥ 12 hours documented by monitoring ECG measurements using ECG patches (ePatch) placed on the participant's chest.
Measured: First 30 days following the initial ICU admission date after open-chest cardiac surgery.
Percentage of Participants With at Least 1 Continuous AF (Atrial Fibrillation or Atrial Flutter) Episode ≥ 24 Hours During the First 30 Days Post-surgery
At least one episode of continuous AF (atrial fibrillation or atrial flutter) sustained ≥ 24 hours documented by monitoring ECG measurements using ECG patches (ePatch) placed on the participant's chest.
Measured: First 30 days following the initial ICU admission date after open-chest cardiac surgery.
Percentage of Participants With at Least 1 Continuous Atrial Fibrillation (Excluding Atrial Flutter) Episode ≥ 30 Seconds During the First 30 Days Post-surgery
At least one episode of continuous atrial fibrillation (excluding atrial flutter) sustained ≥ 30 seconds documented by monitoring ECG measurements using ECG patches (ePatch) placed on the participant's chest.
Measured: First 30 days following the initial ICU admission date after open-chest cardiac surgery.
Percentage of Participants With at Least 1 Continuous Atrial Flutter Episode ≥ 30 Seconds During the First 30 Days Post-surgery
At least one episode of continuous atrial flutter sustained ≥ 30 seconds documented by monitoring ECG measurements using ECG patches (ePatch) placed on the participant's chest.
Measured: First 30 days following the initial ICU admission date after open-chest cardiac surgery.
Percentage of Participants With at Least 1 Continuous Atrial Tachycardia Episode (Defined as the Duration of the Longest Supraventricular Tachycardia [SVT] Run) ≥ 30 Seconds During the First 30 Days Post-surgery
At least one episode of continuous atrial tachycardia sustained ≥ 30 seconds documented by monitoring ECG measurements using ECG patches (ePatch) placed on the participant's chest.
Measured: First 30 days following the initial ICU admission date after open-chest cardiac surgery.
Percentage of Participants With at Least 1 Continuous Episode of Either Atrial Fibrillation or Atrial Flutter or Atrial Tachycardia ≥ 30 Seconds During the First 30 Days Post-surgery
At least one episode of continuous atrial fibrillation or atrial flutter or atrial tachycardia sustained ≥ 30 seconds documented by monitoring ECG measurements using ECG patches (ePatch) placed on the participant's chest.
Measured: First 30 days following the initial ICU admission date after open-chest cardiac surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2018
- Study start1 Mar 2019
- Primary completion24 Mar 2022
- Study completion6 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Post-Operative Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 323 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ABBVIE INC., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03779841
- Sponsor's protocol ID
- 1925-201-008
- Other IDs
- 2017-004399-68, 2017
- Status last verified
- Apr 2024
- First submitted
- 17 Dec 2018
- Last updated
- 14 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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, analyses plans, 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.
Publications
Piccini JP, Ahlsson A, Dorian P, Gillinov AM, Kowey PR, Mack MJ, Milano CA, Noiseux N, Perrault LP, Ryan W, Steinberg JS, Voisine P, Waldron NH, Gleason KJ, Titanji W, Leaback RD, O'Sullivan A, Ferguson WG, Benussi S; NOVA-AF Investigators. Efficacy and Safety of Botulinum Toxin Type A for the Prevention of Postoperative Atrial Fibrillation. JACC Clin Electrophysiol. 2024 May;10(5):930-940. doi: 10.1016/j.jacep.2024.01.020. Epub 2024 Apr 24.
PubMed 38661602Piccini JP, Ahlsson A, Dorian P, Gillinov MA, Kowey PR, Mack MJ, Milano CA, Perrault LP, Steinberg JS, Waldron NH, Adams LM, Bharucha DB, Brin MF, Ferguson WG, Benussi S. Design and Rationale of a Phase 2 Study of NeurOtoxin (Botulinum Toxin Type A) for the PreVention of Post-Operative Atrial Fibrillation - The NOVA Study. Am Heart J. 2022 Mar;245:51-59. doi: 10.1016/j.ahj.2021.10.114. Epub 2021 Oct 20.
PubMed 34687654
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03779841
- Acronym / sponsor ID
- 1925-201-008
- Conditions
- Post-Operative Atrial Fibrillation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 323 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 24 Mar 2022 (actual)
- Study completion
- 6 Mar 2023 (actual)
- First posted
- 19 Dec 2018 (actual)
- Results
- Posted 14 May 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This was 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| AGN-151607 (250 U) | Experimental | Drug: AGN-151607Injections of 50 U were made into each 1 of 5 fat pads. The total injection volume into each fat pad was 1 mL. One-time treatment. |
| AGN-151607 (125 U) | Experimental | Drug: AGN-151607Injections of 25 U were made into each 1 of 5 fat pads. The total injection volume into each fat pad was 1 mL. One-time treatment. |
| Placebo | Placebo comparator | Drug: PlaceboInjections of placebo were made into each 1 of 5 fat pads. The total injection volume into each fat pad was 1 mL. One-time treatment. |
Who may qualify
- Ages
- 55 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (20 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AGN-151607Injections were made into each 1 of 5 fat pads. The total injection volume into each fat pad was 1 mL. One-time treatment. | Drug | AGN-151607 (125 U), AGN-151607 (250 U) |
| PlaceboInjections of placebo were made into each 1 of 5 fat pads. The total injection volume into each fat pad was 1 mL. One-time treatment. | Drug | Placebo |
Primary outcome
Percentage of Participants With at Least 1 Continuous AF (Atrial Fibrillation or Atrial Flutter) Episode ≥ 30 Seconds During the First 30 Days Post-surgery
Time frame: First 30 days following the initial intensive care unit (ICU) admission date after open-chest cardiac surgery.
At least one episode of continuous AF (atrial fibrillation or atrial flutter) sustained ≥ 30 seconds documented by monitoring ECG measurements using ECG patches (ePatch) placed on the participant's chest.
16 secondary outcomes
Percentage of Time Spent in Atrial Fibrillation or Atrial Flutter (AF Burden) During the First 30 Days Post-surgery
Time frame: First 30 days following the initial ICU admission date after open-chest cardiac surgery.
Percentage of Participants With at Least 1 Event of Symptomatic AF (Atrial Fibrillation or Atrial Flutter) During the First 30 Days Post-surgery
Time frame: First 30 days following the initial ICU admission date after open-chest cardiac surgery.
Time to First Occurrence of AF (Atrial Fibrillation or Atrial Flutter) During the First 30 Days Post-surgery
Time frame: First 30 days following the initial ICU admission date after open-chest cardiac surgery.
Percentage of Participants With at Least 1 Continuous AF (Atrial Fibrillation or Atrial Flutter) Episode ≥ 2 Minutes During the First 30 Days Post-surgery
Time frame: First 30 days following the initial ICU admission date after open-chest cardiac surgery.
Percentage of Participants With at Least 1 Continuous AF (Atrial Fibrillation or Atrial Flutter) Episode ≥ 5 Minutes During the First 30 Days Post-surgery
Time frame: First 30 days following the initial ICU admission date after open-chest cardiac surgery.
Percentage of Participants With at Least 1 Continuous AF (Atrial Fibrillation or Atrial Flutter) Episode ≥ 6 Minutes During the First 30 Days Post-surgery
Time frame: First 30 days following the initial ICU admission date after open-chest cardiac surgery.
Percentage of Participants With at Least 1 Continuous AF (Atrial Fibrillation or Atrial Flutter) Episode ≥ 30 Minutes During the First 30 Days Post-surgery
Time frame: First 30 days following the initial ICU admission date after open-chest cardiac surgery.
Percentage of Participants With at Least 1 Continuous AF (Atrial Fibrillation or Atrial Flutter) Episode ≥ 1 Hour During the First 30 Days Post-surgery
Time frame: First 30 days following the initial ICU admission date after open-chest cardiac surgery.
Percentage of Participants With at Least 1 Continuous AF (Atrial Fibrillation or Atrial Flutter) Episode ≥ 4 Hours During the First 30 Days Post-surgery
Time frame: First 30 days following the initial ICU admission date after open-chest cardiac surgery.
Percentage of Participants With at Least 1 Continuous AF (Atrial Fibrillation or Atrial Flutter) Episode ≥ 6 Hours During the First 30 Days Post-surgery
Time frame: First 30 days following the initial ICU admission date after open-chest cardiac surgery.
Percentage of Participants With at Least 1 Continuous AF (Atrial Fibrillation or Atrial Flutter) Episode ≥ 12 Hours During the First 30 Days Post-surgery
Time frame: First 30 days following the initial ICU admission date after open-chest cardiac surgery.
Percentage of Participants With at Least 1 Continuous AF (Atrial Fibrillation or Atrial Flutter) Episode ≥ 24 Hours During the First 30 Days Post-surgery
Time frame: First 30 days following the initial ICU admission date after open-chest cardiac surgery.
Percentage of Participants With at Least 1 Continuous Atrial Fibrillation (Excluding Atrial Flutter) Episode ≥ 30 Seconds During the First 30 Days Post-surgery
Time frame: First 30 days following the initial ICU admission date after open-chest cardiac surgery.
Percentage of Participants With at Least 1 Continuous Atrial Flutter Episode ≥ 30 Seconds During the First 30 Days Post-surgery
Time frame: First 30 days following the initial ICU admission date after open-chest cardiac surgery.
Percentage of Participants With at Least 1 Continuous Atrial Tachycardia Episode (Defined as the Duration of the Longest Supraventricular Tachycardia [SVT] Run) ≥ 30 Seconds During the First 30 Days Post-surgery
Time frame: First 30 days following the initial ICU admission date after open-chest cardiac surgery.
Percentage of Participants With at Least 1 Continuous Episode of Either Atrial Fibrillation or Atrial Flutter or Atrial Tachycardia ≥ 30 Seconds During the First 30 Days Post-surgery
Time frame: First 30 days following the initial ICU admission date after open-chest cardiac surgery.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38661602Piccini JP, Ahlsson A, Dorian P, Gillinov AM, Kowey PR, Mack MJ, Milano CA, Noiseux N, Perrault LP, Ryan W, Steinberg JS, Voisine P, Waldron NH, Gleason KJ, Titanji W, Leaback RD, O'Sullivan A, Ferguson WG, Benussi S; NOVA-AF Investigators. Efficacy and Safety of Botulinum Toxin Type A for the Prevention of Postoperative Atrial Fibrillation. JACC Clin Electrophysiol. 2024 May;10(5):930-940. doi: 10.1016/j.jacep.2024.01.020. Epub 2024 Apr 24.
- Derived from this study: PubMed 34687654Piccini JP, Ahlsson A, Dorian P, Gillinov MA, Kowey PR, Mack MJ, Milano CA, Perrault LP, Steinberg JS, Waldron NH, Adams LM, Bharucha DB, Brin MF, Ferguson WG, Benussi S. Design and Rationale of a Phase 2 Study of NeurOtoxin (Botulinum Toxin Type A) for the PreVention of Post-Operative Atrial Fibrillation - The NOVA Study. Am Heart J. 2022 Mar;245:51-59. doi: 10.1016/j.ahj.2021.10.114. Epub 2021 Oct 20.
- Individual participant dataSharing planned: Yes. 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, analyses plans, 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ABBVIE INC. study director
AbbVie
32 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AGN-151607 in people with Post-Operative Atrial Fibrillation, run by AbbVie at 32 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 sites in United States, Canada, Austria, Germany, Italy and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With at Least 1 Continuous AF (Atrial Fibrillation or Atrial Flutter) Episode ≥ 30 Seconds During the First 30 Days Post-surgery (time frame: First 30 days following the initial intensive care unit (ICU) admission date after open-chest cardiac surgery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03779841, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2024.