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Heart surgery monitoring under the microscope: is the standard test accurate enough?

NCT ID NCT07163052

Knowledge-focused Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026

Summary

This study will compare two ways of measuring pressure inside the heart during heart surgery: the gold standard (direct left atrial pressure) and a more common indirect method (pulmonary capillary wedge pressure). Researchers want to see if the indirect method is accurate enough to guide decisions about fluid management and heart support. About 136 adults having elective heart surgery will take part, and the results could improve how doctors monitor patients during and after surgery.

What this could mean

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

What this could lead to
If successful, this study could confirm that a less invasive pressure measurement is reliable enough for guiding treatment in heart surgery patients.
What could go wrong
This is an observational study, not a treatment trial. It may find that the two measurements do not agree well, meaning current practice needs rethinking but no direct patient benefit is guaranteed.

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 136 people

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

Expected to start

Sep 2025

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

Adult patients undergoing elective cardiac surgery for aortic valve regurgitation, mitral valve, coronary or aortic disease. We aim to include patients without significant impairment in cardiac function. Nonetheless, there are inherent primary and secondary effects of cardiac pathology leading to structural disease. The procedures, as noted in the inclusion criteria (4.2), are standard procedures in our hospital and are regularly performed. We want to select the patient from our wait list. No extra measures are taken to include the patients.

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: * the primary procedure is cardiac surgery by median sternotomy * the use of CPB * patients undergoing aortic valve replacement (AVR) due to aortic regurgitation, mitral valve plasty (MVP), mitral valve repair (MVR), valve sparing aortic root replacement or supracoronary aorta ascendens replacement (SCAR) * left ventricular ejection fraction of 60% or more * no clinical or echocardiographic signs of preoperative decompensation cordis * only elective procedures Exclusion Criteria: * patients with left ventricular hypertrophy (LVH), severe aortic stenosis or hypertrophic obstructive cardiomyopathy. LVH is defined as an increased LVMI greater than 95 grams per square meter (g/m²) in women and greater than 115 g/m² in men. * patients with echocardiographically observed RV or LV dilatation are assessed using specific criteria. For RV dilatation, a TAPSE of less than 14 millimeters or an RV FAC of less than 35% is indicative of dilatation. For LV dilatation, an LV end-diastolic (LVED) diameter greater than 2.7 centimeters per square meter or exceeding 117% of the predicted value, adjusted for age and body surface area, is considered dilated. * patients undergoing more than one type of procedure (i.e. double valve surgery, CABG and AVR) * postoperative aortic valve mean pressure gradient of more than 20 mm Hg and mitral valve mean pressure gradient of more than 5 mm Hg * postoperative paravalvular leak grade 2 or more * postoperative persistent regional wall abnormalities or electrocardiographic signs of acute ischemia * other significant valve pathology, such as moderate mitral regurgitation

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Conditions

The condition(s) this trial relates to.

aortic valve insufficiency cardiogenic shock heart failure mitral valve insufficiency mitral valve prolapse pulmonary edema Shock, Cardiogenic

As listed by the trial registrant

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

Cardiogenic shock Pulmonary edema cardiac cause

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.

More trials for these conditions

Other studies related to the condition(s) this trial covers.