Using amiodarone to prevent atrial fibrillation after esophageal cancer surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase II trial investigates the effectiveness of amiodarone in preventing atrial fibrillation (AF) in patients undergoing minimally invasive esophagectomy (MIE) for esophageal cancer. Patients will be randomly assigned to receive either amiodarone or a placebo following their surgery. The study aims to evaluate not only the incidence of AF but also other postoperative complications and overall hospital costs associated with the treatment. Participants will be monitored for 60 days post-discharge to assess outcomes related to AF and other health metrics.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* All patients undergoing MIE will be evaluated for potential enrollment

  * Indication of cancer, esophageal dysplasia or esophageal dysmotilities
* Age \> 18 years
* Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

* History of chronic or paroxysmal AF, or atrial flutter
* Previous severe adverse reaction or contraindication to amiodarone (e.g., pulmonary toxicity/fibrosis, hepatotoxicity, thyroid dysfunction)
* Current preoperative use of amiodarone, as baseline home medication
* Development of AF intraoperatively
* Pregnancy

  * Negative pregnancy tests are required for participants of childbearing potential (PCBP) on Day of Surgery (DOS)
* Breastfeeding/chest feeding
* Aborted MIE operation
* QTcF (Fridericia formula) \> 500 for heart rate (HR) 60-100 within 30 days

  * For patients with a heart rate (HR) of between 50-59 on their pre-operative screening electrocardiography (EKG), we will first review evidence of chronotropic cardiac response to exercise before inclusion in the study. If a patient's HR increases to ≥ 100 with exercise, the patient is eligible for inclusion of study. Exercise testing options may include a stair climb, a brisk walk, or supine leg-lifts prior to surgery. If exercise is not an option, we can review results of formal stress testing chronotropic response (ie. HR ≥ 100). HR monitoring can be collected by either pulse oximeter or EKG

Where it's running

• OHSU Knight Cancer Institute
  Portland, Oregon, United States Recruiting

Study contacts

• Principal investigator: Stephanie Wood — OHSU Knight Cancer Institute

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• AI-based tools to help diagnose, treat and predict stroke outcomes across multiple hospitals

  This study tests AI-powered tools on real-world stroke patients to see if they can improve pre-hospital triage, diagnosis, and outcome prediction while data stay securely within each hospital.

  Recruiting at 2 sites Hospital Universitari Vall d'Hebron Research Institute · Leuven and 6 other locations · NCT07924371

• Left-atrial Fibrosis in Persistent Atrial Fibrillation and Its Comorbidities

  This study tests how comorbid conditions like sleep apnea and primary aldosteronism relate to left-atrial fibrosis and AF recurrence in patients undergoing ablation.

  Recruiting University Hospital Augsburg · Augsburg, Bavaria · NCT07857044

• Dual Energy ablation with SmartTouch SF catheter in persistent atrial fibrillation

  This study tests a pulsed field and radiofrequency ablation system to treat persistent atrial fibrillation in adults who have not responded well to prior medications.

  Recruiting at 4 sites Biosense Webster, Inc. · Beijing and 3 other locations · NCT07845682

• Identifying AF patients who may need more than standard ablation using Volta AF-Xplorer II

  This trial tests whether AI-identified dispersion areas during AF ablation can predict recurrence after a standard pulmonary vein isolation in patients with persistent AF.

  Recruiting Volta Medical · Avignon and 4 other locations · NCT07807423

• 4D intracardiac echocardiography to guide left atrial appendage occlusion procedures

  A new 4D ICE catheter is being tested alongside standard imaging to see if it can safely guide left atrial appendage occlusion procedures for adults with atrial fibrillation.

  Recruiting The Cleveland Clinic · Cleveland, Ohio · NCT07806890

• Paclitaxel given inside the abdomen with systemic therapy for GI cancers with peritoneal spread

  This phase II study tests a combination of intraperitoneal and systemic chemotherapy (paclitaxel) in adults with digestive tract cancers that have spread to the peritoneum.

  Recruiting Phase 2 University of California, Irvine · Orange, California · NCT07795749

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.