Plain-English translation of NCT04075981 on ClinicalTrials.gov ↗ · Source last updated · Translation generated · How we translate trials
Phase 3 — Testing in thousands of people, comparing the treatment against what doctors currently use. This is the last big step before approval.
This trial is testing whether incobotulinumtoxin A (a medication that blocks nerve signals) can prevent a common type of irregular heartbeat called atrial fibrillation that often develops after heart surgery. The medication is injected into fatty tissue around the heart during surgery, and the goal is to keep your heart rhythm steady in the weeks after your operation. This would be the first large study of this approach in heart surgery patients.
Irregular heartbeats are very common after heart surgery and can cause problems like blood clots and stroke. Researchers believe this medication could reduce those irregular heartbeats by quieting the nerve signals that trigger them, potentially helping thousands of patients each year avoid this complication.
If you are selected, you will be randomly assigned to receive either the study medication or a placebo during your planned heart surgery—the injection is given while your heart is on a heart-lung machine before the main part of the surgery begins. After surgery, you will be monitored closely for the first three weeks and will need to attend several follow-up visits at the heart surgery center so doctors can check your heart rhythm and make sure you are recovering well.
AI-generated summary from trial data · Jul 11, 2026 · Not medical advice
France