Recruiting PHASE4 Postoperative Atrial Fibrillation

Prevention study for Postoperative Atrial Fibrillation

Official title Prevention of Postop Atrial Fibrillation Through Intraoperative Inducibility of Atrial Fibrillation and Amiodarone Treatment

ClinicalTrials.gov ID: NCT03868150

What this study is testing

What is Amiodarone Injection?

Amiodarone Injection is an investigational medicine, given as a twice-daily infusion into a vein, being studied as a potential treatment for postoperative atrial fibrillation.

Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing
Patients undergoing first time cardiac surgery will undergo rapid atrial pacing prior to initiation of cardiopulmonary bypass to screen for AF inducibility. Patients with inducible AF will be randomized to prophylactic amiodarone treatment versus no treatment.
  • Phase 4: studies an already-approved treatment
  • Which group you join is decided by chance.

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 and older. Healthy volunteers may be eligible.

You may be able to join if

  • Patients scheduled for first-time non-emergent open-heart surgery for coronary artery bypass graft (CABG) revascularization, valvular repair or...
  • Normal sinus rhythm
  • No documented history of atrial fibrillation

You likely can't join if

  • Prior surgical procedures involving heart surgery and cardiopulmonary bypass
  • Any prior documented history of atrial fibrillation, atrial flutter or atrial tachycardia lasting longer than 30 seconds
  • Prior history of Amiodarone treatment for the management of supraventricular tachy-arrhythmias
  • Patients requiring surgical treatment of atrial arrhythmias such as pulmonary vein isolation or Maze procedure.

The study team makes the final eligibility decision.

Where it's taking place

  • Stanford, California, United States

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Stanford, California, United States. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.