Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT06067438

Amiodarone for the Prevention of Atrial Fibrillation After Minimally Invasive Esophagectomy in Patients With Esophageal Cancer

Led by OHSU Knight Cancer Institute · Updated on 2025-09-23

90

Participants Needed

1

Research Sites

114 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This phase II trial studies how well amiodarone works in the prevention of atrial fibrillation (AF) after a minimally invasive esophagectomy (MIE) in patients with esophageal cancer. Atrial fibrillation (AF) is an irregular heart rhythm, usually associated with a rapid rate, that is caused by abnormal electrical activity within the atria. AF is the most common complication after MIE for esophageal cancer. There has never been a study of AF after MIE that has used unbiased assignment of patients to receive preventative amiodarone or not. Further, there is no standard recommendation or guideline for preventative medications, such as amiodarone, to decrease the risk of AF in patients having MIE performed for cancer. In fact, most medical centers in the United States and around the world do not give preventative amiodarone after esophagectomy. Giving amiodarone after MIE surgery may be able to reduce the risk of AF for patients with esophageal cancer.

CONDITIONS

Official Title

Amiodarone for the Prevention of Atrial Fibrillation After Minimally Invasive Esophagectomy in Patients With Esophageal Cancer

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients undergoing minimally invasive esophagectomy (MIE) for esophageal cancer, esophageal dysplasia, or esophageal dysmotilities
  • Age over 18 years
  • Ability to understand and willing to sign informed consent
Not Eligible

You will not qualify if you...

  • History of chronic or paroxysmal atrial fibrillation or atrial flutter
  • Previous severe reaction or contraindication to amiodarone (such as lung toxicity, liver toxicity, or thyroid problems)
  • Current use of amiodarone before surgery
  • Development of atrial fibrillation during surgery
  • Pregnancy (negative pregnancy test required on surgery day for those who can become pregnant)
  • Breastfeeding
  • Aborted minimally invasive esophagectomy operation
  • QTcF (heart rate corrected QT interval) over 500 within 30 days prior to surgery
  • For heart rate 50-59 bpm on pre-op EKG, must show heart rate increases to 100 or more with exercise to be eligible

AI-Screening

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Trial Site Locations

Total: 1 location

1

OHSU Knight Cancer Institute

Portland, Oregon, United States, 97239

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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