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New device aims to improve safety in heart valve replacement

NCT ID NCT07205341

Knowledge-focused Sponsor: HemoCept Inc. 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This pilot study is testing a new device called HemoCept that measures blood volume and heart efficiency during trans-aortic valve replacement (TAVR) surgery for aortic stenosis. The study will enroll 20 adults aged 18-80 who need TAVR. Researchers want to see if the device's readings match standard heart measurements taken before and after the procedure.

What this could mean

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

Active substance
HemoCept device
What this could lead to
If successful, this could lead to a new way to monitor blood volume and heart function during TAVR surgery, potentially improving patient safety.
What could go wrong
This is a very small pilot study with only 20 people, so results may not apply to everyone. The device is still experimental and may not work 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.

Participants

About 20 people

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

Started

Apr 2025

Expected to finish

Sep 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Subjects will be between 18 and 80 and above who meet all the Inclusion/Exclusion criteria

Ages

18 to 80 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: * Subjects or representatives must have voluntarily signed the informed consent form before any study related procedures. * Subjects can be any gender but must be between (and including) the ages of 18 and 80. * Subject ls being treated by the participating healthcare facility . ., Subject requires a trans-aortic valve replacement. * Subject is able and willing to provide informed consent and HIPM authorization. * Subject is able and willing to meet all study requirements. Exclusion Criteria: * Subject is pregnant, breast-feeding, or intends to become pregnant during the course of the study. * Subject has a personal medical history that includes: * Long O-T syndrome * Cardiac channelopathies * Seizures

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Conditions

The condition(s) this trial relates to.

aortic valve stenosis

As listed by the trial registrant

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

Aortic valve stenosis

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

  • Boulder Heart

    RECRUITING

    Boulder, Colorado, 80303, United States

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