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Could a placental wrap prevent Post-Surgery heart flutter?

NCT ID NCT04130061

Disease control Sponsor: University of Utah Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 study tested whether placing a thin layer of human amniotic membrane on the heart during bypass surgery could reduce inflammation and prevent post-operative atrial fibrillation (an irregular heartbeat). Twenty-seven patients were randomly assigned to receive either the membrane or standard care. The main goals were to check safety and see if the membrane lowered the rate of atrial fibrillation after surgery.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
human amniotic membrane
What this could lead to
If it works, this could lead to a simple way to lower the risk of irregular heartbeat after heart bypass surgery.
What could go wrong
This was a very early, small safety study (27 people). It is not yet proven to work, and the benefits remain uncertain.

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

27 people

The number who actually took part.

Started

Oct 2019

Finished

Jun 2021

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

18 years and older

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: * Patients undergoing primary elective CABG at the University of Utah Hospital * Ability to provided informed consent and follow-up with protocol procedures Exclusion Criteria: * Patients in AF at the time of surgery * Prior history of sternotomy * Prior history of pericarditis * Currently on aggressive antiarrhythmic therapy (does not include beta blockers) * Patients with an implantable cardiac device (pacemaker, ICD, CRT-D) * Ejection fraction \<45%

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Conditions

The condition(s) this trial relates to.

coronary artery disorder atrial fibrillation prevention target

As listed by the trial registrant

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

Atrial fibrillation

Contacts and locations

Locations

  • University of Utah

    Salt Lake City, Utah, 84132, United States

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