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Heart surgery study tests new material for closing the Heart's protective sac

NCT ID NCT06136182

Disease control Sponsor: Methodist Health System 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
The trial has finished. Results may not be published yet.
Stopped early This study
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This status has not been confirmed recently, so it may be out of date.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 study compared two materials, Gentrix and CorMatrix, used to close the pericardium (the sac around the heart) after heart surgery. Researchers looked at how long patients stayed in the hospital and whether they were readmitted within 30 days. The trial was terminated early, so the findings are incomplete.

What this could mean

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

Active substance
Gentrix (a material used to close the sac around the heart after surgery)
What this could lead to
If successful, Gentrix could offer an alternative to CorMatrix for closing the pericardium after heart surgery, potentially reducing complications like fluid buildup.
What could go wrong
The trial was terminated early, so results are limited. It is unclear if Gentrix is better or safer than the standard option.

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.

Participants

489 people

The number who actually took part.

Started

May 2023

Finished

Apr 2026

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.

Who is studied

* Must have undergone a CABG or valve repair/replacement surgery requiring pericardial reconstruction. * CABG or valve repair/replacement surgery must have been either elective or urgent status

Ages

18 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: * Must have undergone a Coronary Artery Bypass Grafting(CABG) or valve repair/replacement surgery requiring pericardial reconstruction. CABG or valve repair/replacement surgery must have been either elective or urgent status Exclusion Criteria: -CABG or valve repair/replacement surgery classified as emergent status Surgery classified as redo-sternotomy

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As listed by the trial registrant

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

Clinical outcome of pericardial closure using gentrix

Contacts and locations

Locations

  • Clinical Research Institute at Methodist Health System

    Dallas, Texas, 75203, United States

  • Methodist Dallas Medical Center

    Dallas, Texas, 75203, United States