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New monitor tested in transplant patients to improve care

NCT ID NCT07148323

Knowledge-focused Sponsor: Becton, Dickinson and Company 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Aug 27, 2026 · Updated 4 times

Summary

This study is testing a new monitoring platform called HemoSphere Alta in 100 adults having heart or liver transplant surgery. The goal is to collect data to help improve the device, not to treat a disease. Participants must be at least 18 years old and already scheduled for a pulmonary artery catheter during surgery.

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 100 people

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

Started

Oct 2025

Expected to finish

Dec 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

Up to 100 subjects with planned monitoring with a pulmonary artery catheter in the Operating Room (OR). Subjects must meet the eligibility criteria for the Primary Cohort to be enrolled in the study. Subjects may further qualify for inclusion in Sub-Cohorts A and/or B. Sub-Cohort A Right Ventricular Failure (RVF) will include up to 25 subjects undergoing either non-cardiac or cardiac surgery with a planned transesophageal echocardiogram (TEE) assessment. Sub-Cohort B Cerebral Autoregulation Index (CAI) will include up to 50 subjects aged ≥ 45 years undergoing Cardiopulmonary Bypass (CPB) with the ability to place ForeSight and Acumen IQ sensors and are at high risk for cerebrovascular disease.

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: 1. Signed informed consent 2. Age ≥ 18 years 3. Planned monitoring with a pulmonary artery catheter 4. Patient scheduled to undergo cardiac or liver transplant surgery lasting \> 2 hours 5. Additional criteria for Sub-Cohort A (RVF) 1. Possible Right Ventricular Dysfunction/Failure based on pre-operative assessment of previous Transthoracic Echocardiogram (TTE) 2. Planned Transesophageal Echocardiogram (TEE) assessment during the operative procedure 6. Additional criteria for Sub-Cohort B (CAI) 1. Age ≥ 45 years 2. Planned cardiac surgery with Cardiopulmonary Bypass (CPB) 3. Ability to place ForeSight IQ and Acumen IQ sensors during the operative monitoring period 4. High risk for cerebral vascular disease, defined as: a history of hypertension, pulse pressure \> 60 mmHg, diabetes, stroke, transient ischemic attack, carotid bruit, tobacco smoking, or peripheral vascular disease Exclusion Criteria: 1. Inability to provide informed consent 2. Pregnancy as confirmed per EMR 3. Patients deemed not suitable for the study at the discretion of the Investigator 4. Participation in another study that clinically interferes with the current study 5. Additional exclusion criteria for Sub-Cohort A 1. Presence of left bundle branch block 2. Presence of current/recurrent sepsis 3. Presence of hypercoagulability, as identified in the patient's past medical history and preoperative evaluation 4. Structural abnormality, including congenital heart defects, of the right ventricle 6. Additional exclusion criteria for Sub-Cohort B a. Surgery for congenital heart defect

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As listed by the trial registrant

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

Hemodynamic instability

How to take part

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  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

  • University of Rochester Medical Center

    RECRUITING

    Rochester, New York, 14620, United States

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