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Phase 2 N=130 Randomized Quadruple-blind Prevention

Temporary Autonomic Blockade to Prevent Atrial Fibrillation After Cardiac Surgery

Atrial Fibrillation

Enrolled (actual)
130
Serious AEs
43.9%
Results posted
Dec 2018
Primary outcome: Primary: Time to In-hospital Post-operative Atrial Fibrillation (POAF) — 224.38; 194.76 hours — p=0.18

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
Botulinum Toxin Type A (Drug); Placebo (Drug)
Age
Adult, Older Adult · 50+ yrs
Sex
All
Sponsor
Joseph Mathew, M.D.
Primary completion
Sep 2017

Outcome Measures

OutcomeResultp-value
PRIMARY
Time to In-hospital Post-operative Atrial Fibrillation (POAF)
224.38; 194.76 0.18
SECONDARY
Number of Participants With In-hospital POAF
23; 32 0.19
SECONDARY
Length of Stay
25.7; 23.1; 145; 149 .16
SECONDARY
Number of Participants With Adverse Events
44; 47 .97

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.

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • 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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02498769). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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