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
- Conditions
- post-operative atrial fibrillationheartfailure10019280
- Registration Number
- NL-OMON55701
- Lead Sponsor
- Allergan Ltd.
- Brief Summary
Trial never started
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- Not specified
- Target Recruitment
- 30
1.01- Participants must be 55 to 90 years of age, inclusive, at the time of
signing the informed consent.
2.01- Participants who are scheduled to undergo open-chest cardiac surgery.
Includes: coronary artery bypass graft (CABG) and/or valve repair/replacement.
3.01- Male or female
4.01- Male participants willing to minimize the risk of inducing pregnancy up
to Day 60.
A male participant must agree to use contraception as detailed in Appendix 7,
Section 10.7 of this protocol until Day 60 and refrain from donating sperm
during this period.
4.02- Female participants willing to minimize the risk of inducing pregnancy up
to Day 60.
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:
a. Not a woman of childbearing potential (WOCBP) as defined in Appendix 7,
Section 10.7
• OR
b. A WOCBP who agrees to follow the contraceptive guidance in Appendix 7,
Section 10.7 of this protocol until after Day 60.
5.01- Capable of giving signed informed consent as described in Appendix 1,
Section 10.1, which includes compliance with the requirements and restrictions
listed in the informed consent form (ICF) and in this protocol.
5.02- Written informed consent from the participant has been obtained prior to
any study related procedures.
5.03- 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 [EU] sites).
6.01- In sinus rhythm for the last 48 hours prior to surgery (prior history of
paroxysmal atrial fibrillation (AF) is acceptable).
6.02- Willing to wear an electrocardiogram (ECG) patch for 30 days post-surgery
and for 7 days after each study visit
6.03- Able, as assessed by the investigator, and willing to follow study
instructions and likely to complete required study visit.
1.01- 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.
1.02- 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.
1.03- 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.
1.04- Permanent/persistent atrial fibrillation (AF)
1.05- Has a known allergy or sensitivity to any botulinum toxin type A
preparation.
1.06- Has a known allergy or sensitivity to medical adhesive (eg, ECG patch
adhesive; hydrogel-based adhesive).
1.07- Severe (> 55mm) atrial enlargement
1.08- Left ventricular ejection fraction (LVEF) < 25%
1.09- Presence or history of symptomatic atrioventricular block > 1st degree
within the last 30 days
2.01- Class I or III antiarrhythmic drugs unless proper washout was documented
(Section 6.5.1)
2.02- Botulinum toxin type A (of any serotype) use within 6 months of
randomization
2.03- Has been immunized for any botulinum toxin type A serotype as determined
by participant medical history
2.04- Preoperative need for inotropes/vasopressors or intra-aortic balloon pump
2.05- Prior cardiac surgery
2.06- History of ablation for AF
2.07- Planned ablation procedure for AF at the time of surgery
2.08- Emergency surgery
3.01- Current enrollment in an investigational drug or device study or
participation in such a study within 30 days of entry into this study
4.01- Participants have diagnostic assessments which in the opinion of the
investigator prevent participation in the study.
4.02- Impaired prognosis defined as EuroSCORE II greater than 7% perioperative
mortality
5.01- Females who are pregnant, nursing, or planning a pregnancy during the
study
5.02- 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Percentage of participants with at least 1 continuous atrial fibrillation (AF)<br /><br>episode >= 30 seconds during the first 30 days post surgery</p><br>
- Secondary Outcome Measures
Name Time Method