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Heart surgery device gets a safety check in new study

NCT ID NCT07628920

Knowledge-focused Sponsor: Bıçakcılar Tıbbi Cihazlar Sanayi ve Ticaret A.Ş. 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 study will look at how a vent catheter performs and stays safe when used during heart surgery that requires a heart-lung machine. The device helps drain blood from the heart to prevent damage. Researchers will track 45 patients and rate things like bleeding, ease of use, and whether the device keeps its shape. The goal is to make sure the catheter works as intended after it has already been approved for use.

What this could mean

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

Active substance
vent catheter
What this could lead to
If successful, this study could confirm that the vent catheter is safe and effective for routine use during heart surgery.
What could go wrong
This is a small, observational post-market study with only 45 participants. It is not designed to prove the device works better than others, and results may not apply to all patients.

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

About 45 people

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

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Oct 2026

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.

Who is studied

* Patients with diseased or abnormal tissue at the catheter insertion site * Patients with intracardiac and/or major intravascular thrombi and/or masses * Patients with left atrial/ventricular myxoma * Patients who have difficulty understanding or complying with the study * Patients who may present a conflict of interest (e.g., relatives of employees of the sponsoring company) * Patients who have participated in any clinical trial within the past 30 days

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

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 who have consulted the Department of Cardiovascular Surgery and for whom the physician has decided to perform heart surgery using the cardiopulmonary bypass technique, * Patients for whom the use of a vent catheter is planned during surgery * Patients who, in the "Use of Patient Data for Educational and Research Purposes" section of the Department of Cardiovascular Surgery Informed Consent Form, have given permission for their data to be used Exclusion Criteria: * • Patients with diseased or abnormal tissue in the catheter placement site * Patients with intracardiac and/or major intravascular thrombi and/or masses * Patients with left atrial/ventricular myxoma * Patients who have difficulty understanding or complying with the study * Patients who may pose a conflict of interest (e.g., relatives of employees of the sponsoring company) * Patients who have participated in any clinical trial within the past 30 days

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As listed by the trial registrant

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

Cardiopulmonary bypass surgery

How to take part

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  1. 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 ↗

  2. 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.

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