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Heart device safety check underway

NCT ID NCT07628907

Disease control 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 is checking how well a device called an aortic root cannula works and how safe it is during heart surgery that uses a heart-lung machine. About 20 patients will be watched to see if there is any bleeding or other issues. The goal is to make sure the device is safe for regular use.

What this could mean

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

Active substance
aortic root cannula (a device used during heart surgery to deliver fluids to the heart)
What this could lead to
If successful, this study will confirm that this device is safe and works as intended for heart surgery patients.
What could go wrong
This is a small, observational study with only 20 patients, so results may not apply to everyone. It is not testing a new treatment, just checking an existing device.

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 20 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

The aim of this study is not to prove a hypothesis defined by a specific objective-numerical expectation, but rather to compile the various outcomes resulting from the use of a medical device, using data obtained from all cases collected within a timeframe deemed clinically appropriate and sufficient. In this context, a minimum sample size is determined without considering an objective expectation or the Type I and Type II statistical errors accepted in the research. The sample will be formed by including participants such that even for the option with the fewest patients operated on-among the four options comprising two operative procedures and two cannula types-there will be at least 5 cases. Since the selection of the appropriate cannula is determined by the surgeon based on the patient's condition and characteristics, this sample will, to some extent, attempt to reflect real-world data on cannula use on a small scale.

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 an aortic root cannula is planned during surgery * Patients who, prior to surgery, have provided consent in the "Cardiovascular Surgery Department Information and Consent Form, Use of Patient Data for Educational and Research Purposes" section regarding the use of their data Exclusion Criteria: * Patients known to have hypersensitivity to any of the materials used in the device components (PVC, ABS, stainless steel) * Patients with calcified aorta, aortic valve insufficiency, occluded coronary arteries, the presence of adventitia or plaques, fibrosis in the aortic wall, or low arterial pressure Patients who have difficulty understanding the study and complying with it * Patients who may pose a conflict of interest (e.g., relatives of employees of sponsoring companies) * 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

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

  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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