Screening and Prophylactic Amiodarone Reduces Post-Operative Atrial Fibrillation in At-Risk Patients.
Terrence Pong, Kevin Cyr, John Niesen...
https://pubmed.ncbi.nlm.nih.gov/32192666/Actively Recruiting
Led by Stanford University · Updated on 2026-02-17
600
Participants Needed
1
Research Sites
1043 weeks
Total Duration
Researchers are studying patients undergoing their first cardiac surgery to see if rapid atrial pacing during surgery can predict the development of postoperative atrial fibrillation POAF. The trial evaluates whether using this pacing test to identify patients who may benefit from preventive treatment with amiodarone can reduce the occurrence of AF after surgery. This phase 4 study aims to improve how doctors manage the risk of AF following heart operations. During surgery, the surgeon will briefly stimulate the upper right part of the heart with a pacemaker for 30 seconds before starting heart-lung bypass. If this causes atrial fibrillation lasting at least 30 seconds, patients are randomly assigned to receive either preventive amiodarone treatment or no initial drug treatment. Those without induced AF receive standard postoperative care. Amiodarone is given starting with an intravenous dose during surgery followed by continuous IV infusion and then oral doses until discharge. Participants will be closely monitored after surgery to track if they develop AF and to assess how well the test predicts this condition. The main outcome measured is the reduction in new AF episodes within 30 days after surgery. The study includes heart rhythm monitoring, documentation of treatment effects, and routine follow-up until hospital discharge and beyond. Overall participation involves the surgical procedure, drug administration if assigned, and postoperative observation.
CONDITIONS
Prevention of Postop Atrial Fibrillation Through Intraoperative Inducibility of Atrial Fibrillation and Amiodarone Treatment
A
Anson Lee, MD
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Stanford University
Lead Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | Amiodarone (intraoperative loading + oral until discharge) | No amiodarone (standard care) | Prophylactic amiodarone per current STS guideline |
|---|---|---|---|
| What the approach is | Intraoperative rapid atrial pacing followed by IV loading then oral amiodarone until discharge | Intraoperative rapid atrial pacing without amiodarone (standard care) | Prophylactic perioperative amiodarone is recommended by guidelines to prevent postoperative atrial fibrillation |
| Role in study | Intervention arm receiving investigational amiodarone protocol | Control arm representing standard postoperative care without amiodarone | Reflects current recommended prophylactic treatment outside of trial |
| Primary use | To prevent postoperative atrial fibrillation in patients with intraoperative inducibility | To observe incidence of postoperative atrial fibrillation under standard care | To reduce risk of postoperative atrial fibrillation in clinical practice |
| How it is given or performed | 150 mg IV loading before bypass then IV infusion for 24 h, then 400 mg oral twice daily until discharge | No amiodarone administered perioperatively | Perioperative amiodarone following dosage and timing per guideline (e.g., loading then oral protocol) |
| Evidence status | Efficacy under investigation; trial measuring postoperative AF incidence | Control condition; evidence reflects usual care without prophylaxis | Prophylactic amiodarone has demonstrated efficacy in reducing postoperative AF in multiple studies and guideline recommendations |
| Important risks | Potential for bradycardia or heart block, as known amiodarone adverse effects | Risks reflect standard postoperative complications without added drug risk | Amiodarone prophylaxis may carry small risk of bradycardia or heart block (~2‑4% and 1‑2% respectively in evidence reviewed) |
| Important limitations | Trial focuses on intraoperative inducibility subgroup and may not generalize to all cardiac surgical patients | Standard care arm lacks prophylaxis, which may differ from current practice where prophylactic amiodarone is guideline‑recommended | Guideline‑recommended prophylaxis not randomized in trial so comparative effectiveness versus intraoperative strategy remains untested |
| Patient‑relevant outcome | Not yet established; trial will assess reduction in postoperative atrial fibrillation incidence | Baseline outcome of postoperative AF incidence under standard care | Established reduction in postoperative AF incidence and shorter hospital stay supported by meta‑analysis and guideline recommendations |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Day of surgery
During open heart surgery, participants undergo rapid atrial pacing for 30 seconds to assess atrial fibrillation inducibility. Based on the results, participants may receive prophylactic amiodarone treatment or standard care. The remainder of the surgical procedure follows routine practice.
1 in-person surgery visit
Duration - Until hospital discharge
Participants with inducible atrial fibrillation may receive intravenous and oral amiodarone treatment until discharge. Those without inducible atrial fibrillation or receiving standard care may be treated with amiodarone only if post-operative atrial fibrillation occurs.
Daily monitoring during hospital stay
Duration - 30 days post-surgery
Participants are monitored for up to 30 days after surgery to assess the incidence of post-operative atrial fibrillation.
Follow-up visits as per routine care
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
3
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Terrence Pong, Kevin Cyr, John Niesen...
https://pubmed.ncbi.nlm.nih.gov/32192666/Stanford University
Lead Sponsor