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Heart surgery patients may get new shield against dangerous rhythm

NCT ID NCT06063538

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-phase study tests whether placing amiodarone directly into the sac around the heart during open-chest surgery can prevent a common and serious irregular heartbeat called atrial fibrillation. About 63 adults aged 20-85 having bypass or valve surgery will receive this treatment. The goal is to see if this approach reduces hospital complications and extra time in the ICU.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

About 63 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2024

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

20 to 85 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Subject aged 20-85 years old. * Patients able to provide written informed consent, understand, and be willing to comply with study-related procedures. * Participants who are scheduled to undergo open-chest cardiac surgery via complete median sternotomy. Includes: * Coronary artery bypass graft (CABG) and/or valve repair/replacement procedures (aortic, mitral, or tricuspid) * Isolated ascending aortic aneurysm replacement/repair * Note: Left atrial appendage (LAA) procedures are allowed if CABG and/or valve repair or replacement is the qualifying surgical procedure, but is not a qualifying surgical procedure on its own. * In sinus rhythm at the time of office visit and prior electrocardiogram (EKG) (note: continuous EKG monitoring for 48 hours is not required). Exclusion Criteria: * Subject unable to give voluntary written informed consent, is unlikely to cooperate or is legally incompetent, including subjects who are institutionalized by court or official order, or in a dependency relationship with, testing center or investigator. * Any condition which could interfere with the subject's ability to comply with the study. * Ongoing participation in an interventional clinical study or during the preceding 30 days. * Female subjects who are pregnant, breastfeeding, were pregnant within the last three months, or are planning to become pregnant during the course of the study. * Active skin or deep infection at the site of implantation. * History of chronic wounds or wound-healing disorders. * Known connective tissue diseases (e.g. Ehlers-Danlos syndrome, Epidermolysis bullosa, Marfan syndrome, Osteogenesis imperfecta). * Immune-suppressed subjects, immune-deficiency subjects (properly managed diabetes mellitus is not an exclusion criterion). * Concomitant oral or IV systemic corticosteroid therapy and/or other constant anti-inflammatory therapies. * Patients already receiving amiodarone as a treatment for atrial fibrillation or ventricular arrhythmias. * Disease of the left pleura, previous intervention in the left pleural space, or chest deformity. * Subjects with end-stage chronic-renal disease / dialysis. * STS (Society of Thoracic Surgeons Score) risk score \>5.5% for 30 day mortality.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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  3. A doctor treating you

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Contacts and locations

Locations

  • The University of Chicago

    RECRUITING

    Chicago, Illinois, 60637, United States

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