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Simple surgical trick may prevent dangerous heart rhythm after bypass or valve surgery

NCT ID NCT06728826

Prevention Sponsor: Changhai Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 14, 2026 · Last updated Jul 15, 2026 · Updated 1 time

Summary

This trial tests whether making a small opening in the sac around the heart (posterior pericardiotomy) during heart surgery can prevent a common complication called atrial fibrillation. About 650 adults in China having surgery on the heart's valves, coronary arteries, or aorta will be randomly assigned to receive the procedure or not. The main goal is to see if it reduces cases of atrial fibrillation within 30 days 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
a surgical procedure called posterior pericardiotomy, where a small opening is made in the sac around the heart to drain fluid
What this could lead to
If effective, this simple surgical step could become a standard way to prevent a common and serious heart-rhythm problem after cardiac surgery.
What could go wrong
This is a single-country trial, so results may not apply everywhere. The procedure also carries risks like bleeding or infection, and it may not reduce atrial fibrillation as hoped.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 650 people

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

Started

Dec 2025

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

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 older than or equal to 18 years of age * Requiring surgical intervention on proximal aorta, cardiac valves, and/or coronary arteries * Able to provide informed consent Exclusion Criteria: * History of atrial fibrillation or flutter * Reoperations/minimally invasive cardiac surgery/emergent presentation * Need for hypothermic circulatory arrest * Disease of the left pleura or previous left thoracotomy * Chest deformity * Unlikely to participate in follow-up assessments

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Conditions

The condition(s) this trial relates to.

cardiovascular disorder pericardial effusion atrial fibrillation prevention target

As listed by the trial registrant

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

Atrial fibrillation (AF) Cardiac events Pericardial effusion

How to take part

Only the study team decides who joins. These are the ways to reach them.

  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.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Changhai Hospital

    RECRUITING

    Shanghai, 200433, China

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