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Study on Preventing Post-Operative Atrial Fibrillation with Botulinum Toxin Injections in Patients Undergoing Cardiac Surgery

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on preventing a heart rhythm problem called atrial fibrillation that can occur after heart surgery. The study involves patients who are undergoing heart surgeries such as coronary artery bypass grafting, aortic valve repair, or surgery on the ascending aorta. The treatment being tested is an injection of Botulinum toxin, also known as Xeomin or IncobotulinumtoxinA, into specific fat pads around the heart's pulmonary veins during surgery. This toxin is a protein that can affect nerve activity and is being studied for its potential to prevent atrial fibrillation after surgery.

The purpose of the study is to determine if these injections can effectively prevent atrial fibrillation in the weeks following heart surgery. Participants in the study will receive either the Botulinum toxin injection or a placebo, which is a substance with no active medication. The study will monitor the heart rhythm of participants for three weeks after their surgery to see if the treatment helps reduce the occurrence of atrial fibrillation.

Throughout the study, participants will have their heart rhythm checked regularly using devices like a Holter monitor and daily heart monitoring. The results will be reviewed by cardiologists to assess the effectiveness of the treatment. This research aims to find a new way to help patients recover from heart surgery with fewer complications related to heart rhythm.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the patient will be informed about the trial's purpose and procedures. The patient must provide informed consent to participate.

    Eligibility criteria include being between 18 and 80 years old, having a stable heart condition, and being scheduled for specific types of heart surgery.

  2. Step 2

    Pre-surgery preparation

    Before surgery, the patient will undergo a randomization process to determine whether they will receive the botulinum toxin or a placebo.

    The patient must be in sinus rhythm, which means a normal heart rhythm, at the time of randomization.

  3. Step 3

    Surgery and treatment

    During the cardiac surgery, injections of botulinum toxin or placebo will be administered into the epicardial fat pads around the pulmonary veins.

    The product used is Xeomin 200 units, which is a solution for injection.

  4. Step 4

    Post-surgery monitoring

    After surgery, the patient will be monitored for rhythm disorders, specifically atrial fibrillation, for up to 21 days.

    Monitoring will include daily ECG checks for the first 7 days and continuous recording with a Holter monitor for the first 21 days.

  5. Step 5

    Evaluation of results

    Two independent cardiologists will review the monitoring data to determine the presence of any rhythm disorders.

    The primary goal is to assess the effectiveness of the botulinum toxin in preventing postoperative atrial fibrillation.

Who can join the trial?

8 criteria

  • Must need heart surgery, such as CABG (a type of heart surgery), aortic valve repair or replacement (except for a special type called sutureless valve), or surgery on the ascending aorta, as per European Heart Association guidelines.
  • Must be in a stable condition, meaning the heart and blood circulation are working well.
  • Must have a normal heart rhythm, known as sinus rhythm, at the time of selection. This is checked with an ECG, a test that records the heart's electrical activity.
  • Must be between 18 and 80 years old.
  • Women who can have children must have a negative pregnancy test, either from blood or urine.
  • Must be able to visit the study center for several appointments.
  • Must have signed an informed consent form, which means they understand the study and agree to participate.
  • Must be part of the French social security system.

Who cannot join the trial?

5 criteria

  • Patients who are not adults cannot participate. This means only individuals who are 18 years or older are eligible.
  • Patients who do not need conventional heart surgery, such as CABG (a type of heart surgery to improve blood flow to the heart), aortic replacement, or surgery on the ascending aorta, are not eligible.
  • Patients who have already had heart surgery more than three weeks ago cannot participate.
  • Patients who are not able to undergo the procedure of injecting Botulinum toxin (a substance used to prevent certain complications after surgery) into the heart's fat pads are excluded.
  • Patients who are part of a vulnerable population, meaning they might have additional risks or challenges, are not eligible.
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Investigated drugs

Botulinum Toxin is used in this clinical trial. It is injected into specific areas around the heart, known as epicardial fat pads, during cardiac surgery. The purpose of this treatment is to prevent a common complication called atrial fibrillation, which can occur after heart surgery. Atrial fibrillation is a type of irregular heartbeat that can lead to other heart-related issues. The trial aims to see if these injections can effectively reduce the risk of developing this condition within three weeks after the surgery.

What is already known about the treatment

Botulinum Toxin – This medication is administered through injections directly into the epicardial fat pads around the pulmonary veins during cardiac surgery. It is currently being studied in clinical trials to assess its effectiveness in preventing postoperative atrial fibrillation in patients undergoing conventional cardiac surgeries such as coronary artery bypass grafting or aortic replacement. The main therapeutic indication is to reduce the incidence of atrial fibrillation after surgery. At the molecular level, Botulinum toxin works by blocking the release of neurotransmitters, which helps in reducing abnormal heart rhythms. It is classified pharmacologically as a neurotoxin.

Investigated diseases

Atrial Fibrillation – Atrial fibrillation is a common heart rhythm disorder where the heart's upper chambers (atria) beat irregularly and often rapidly. This irregular rhythm can lead to poor blood flow and may cause symptoms like palpitations, fatigue, and shortness of breath. The condition can occur sporadically or become a chronic issue. It often progresses from short, infrequent episodes to longer, more persistent ones. Over time, atrial fibrillation can lead to complications such as heart failure or stroke if not managed properly. The progression and severity can vary widely among individuals.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-513645-37-00Protocol codeP170912JEstimated enrolment220 patientsSponsorAssistance Publique Hopitaux De Paris

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