Temporary Autonomic Blockade to Prevent Atrial Fibrillation After Cardiac Surgery (NCT02498769) | Clinical Trial Compass
CompletedPhase 1/2
Temporary Autonomic Blockade to Prevent Atrial Fibrillation After Cardiac Surgery
United States130 participantsStarted 2015-09
Plain-language summary
In this study, the investigators aim to determine whether injecting botulinum toxin into epicardial fat pads is efficacious and safe for decreasing postoperative atrial fibrillation (POAF) after cardiac surgery. The investigators will test the hypothesis that botulinum toxin injected into the epicardial fat pads reduces POAF and length of stay (LOS) without increasing adverse events. This will be a prospective randomized trial of 130 patients undergoing coronary artery bypass graft (CABG), valve surgery or CABG + valve surgery with cardiopulmonary bypass. Patients will be randomized to receive either botulinum toxin (50 units per fat pad, n=65) or normal saline/placebo (1 mL per fat pad, n=65) injected into epicardial fat pads. All patients will receive standardized anesthetic, surgical, and post-surgical care. The primary outcome in this study will be time to occurrence of in-hospital POAF. Based on previous work and a pilot trial showing a pronounced reduction (relative risk reduction 77%) in POAF after injecting botulinum into the epicardial fat pads, the investigators anticipate a significant reduction in the risk for POAF with epicardial botulinum in this cohort, which includes valve surgery patients.
Who can participate
Age range
50 Years – 90 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Undergoing cardiac surgery with cardiopulmonary bypass via median sternotomy
* coronary artery bypass graft (CABG)
* valve surgery
* CABG + valve surgery
Exclusion Criteria:
* \< 50years of age
* \> 90years of age
* chronic AF or AF at the time of screening
* preoperative heart block (second degree or greater)
* LVEF \< 25%
* renal failure
* hepatic failure
* known sensitivity to Botulinum toxin
* debilitating neuromuscular disease
* preoperative need for inotropes/vasopressors or intra-aortic balloon pump
* planned MAZE procedure
* history of catheter ablation for AF
* use of Vaughan-Williams class I or III drugs within 5 elimination half lives (or within 2 months for amiodarone)
* undergoing minimally-invasive cardiac surgery
* prior cardiac surgery
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Time to In-hospital Post-operative Atrial Fibrillation (POAF)
Timeframe: From the time of ICU arrival until the time of first documented POAF, or discharge whichever came first, assessed up to 2 weeks