Temporary Autonomic Blockade to Prevent Atrial Fibrillation After Cardiac Surgery

Completed · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Atrial Fibrillation

In brief

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.

Key facts

Study ID

NCT02498769

Run by

Joseph Mathew, M.D.

People needed

130

Starts

2015-09-01

Expected to finish

2018-12-01

Last updated by the study team

2019-02-22

Who can join

Age: 50 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Undergoing cardiac surgery with cardiopulmonary bypass via median sternotomy
• coronary artery bypass graft (CABG)
• valve surgery
• CABG + valve surgery

You may not qualify if…

• < 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

Where it is running

• Duke University Medical Center — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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