Heart DiseasesNCT06154265

Intraoperative Echocardiography in Low-Risk CABG Surgery

A study testing TEE probe in people with Heart Diseases and Coronary Artery Disease, run by University of Pennsylvania at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This goal of this study is to better understand when and where intraoperative transesophageal echocardiography (TEE) should (or should not) be used during coronary artery bypass graft (CABG) surgeries. Read more about this study

Who is it for?: Ages 18 to 100 years
Conditions the study is for: Heart Diseases, Coronary Artery Disease, Chest Pain
What is being tested?: TEE probe
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 40 participants
Where: 1 siteUnited States
Study dates: 22 Jan 2024to 15 Mar 2026
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 100 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Scheduled to undergo isolated CABG surgery at a hospital within the UPenn Health System
Age ≥18 years
Ejection fraction ≥50%
Transthoracic echocardiography within one year of scheduled surgery date
Left heart catheterization within one year of scheduled surgery date
English language fluency or facilitated via language interpreter
Able to provide informed consent either in English or via a language interpreter
Willing to comply with all study procedures

Who cannot join

Documented valve (aortic, mitral, tricuspid, or pulmonic) disease (stenosis or regurgitation) moderate or greater.
Any CABG surgery with either "possible" or "definite" aortic intervention listed as a planned part of the procedure. plan for either definite or possible surgical intervention.
Any CABG surgery with either "possible" or "definite" valve repair/replacement listed as a planned part of the procedure.
Having undergone any previous cardiac surgeries (i.e. scheduled with a "REDO" modifier).
Proximal/critical left main coronary disease (e.g. greater than or equal to 90% stenosis).
Preexisting anomalous coronary arteries

Show all 33Show fewer

Preexisting end-stage renal disease on hemodialysis
Preexisting chronic kidney disease (CKD) stage 3, 4, or 5
Stroke with residual focal neurological deficit(s) within 90 days of surgery
Any of the following presurgical, mechanical circulatory support devices:
Intraaortic balloon pump
Percutaneous right ventricular assist device (RVAD)
Impella
Extracorporeal membrane oxygenation (ECMO)
Absolute contraindication to echocardiography defined as one or more of the following documented conditions:
Esophagectomy
Esophagogastrectomy
Esophageal trauma
Any of these three relative contraindication to TEE:
Esophageal varies
Gastric bypass surgery
Descending thoracic aortic aneurysm
Severe pulmonary hypertension defined as:
Pulmonary arterial pressure ≥60 mmHg
Pulmonary vascular resistance (PVR) ≥3 Woods Units
Hemodynamic instability after induction and following placement of an endotracheal tube will be defined as one or more of the following events or scenarios:
Placement of an intraaortic balloon pump (IABP)
Initiation of venoarterial extracorporeal membrane oxygenation (VAECMO)
Placement of a right or left percutaneous mechanical circulatory support device
Initiation of epinephrine infusion at a dose ≥ 6 mcg/min for a duration ≥5 minutes
Initiation of norepinephrine at a dose ≥8 mcg/min for a duration ≥ minutes
Initiation of phenylephrine infusion at a dose ≥100 mcg/min for a duration ≥ minutes
Initiation of vasopressin infusion at a dose ≥0.04 units/min for a duration ≥ minutes

Trial locations and contacts

1 site in 1 country.

United States1 site

Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104

Other trials in United States

About this study

Official title: Default vs As-Needed Intraoperative Transesophageal Echocardiography (TEE) in Low-Risk Isolated Coronary Artery Bypass Graft (CABG) Surgery: A Randomized Controlled Trial

Read the detailed description

This trial will look at benefits and harms to two different treatments strategies in order to improve clinical outcomes. Intraoperative TEE is an ultrasound-based, imaging device that uses sound waves to look at the heart continuously during a heart surgery.

Conditions: Heart Diseases, Coronary Artery Disease, Chest Pain, Stenosis Coronary, STEMI
Being tested: TEE probe
Keywords: Heart, Chest Pain, Artery, Stenosis, TEE, CABG, Bypass
Medical subject headings: Heart Diseases, Coronary Artery Disease, Chest Pain, Coronary Stenosis, ST Elevation Myocardial Infarction, Constriction, Pathologic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TEE probeDevice
Also called Philips transesophageal echocardiography (TEE), ultrasound probe
Transesophageal echocardiography, ultrasound probe

Study groups in NCT06154265
Study group	Role	What they receive
Default TEE	Active comparator	The TEE probe is placed after going under general anesthesia and a breathing tube is placed. TEE issued to take pictures of the heart before and after a CABG surgery. If randomized to this group, the TEE probe will remain in place throughout the surgery. Receives: Device: TEE probe
As-needed TEE	Other	The TEE probe is placed only in situations where a surgeon requires information that can only be obtained by ultrasound imaging of the heart. Receives: Device: TEE probe

What is being measured

The primary outcome is the main question the study is designed to answer.

Enrollment and Randomization Feasibility
Enrollment and randomization feasibility defined as the proportion of patients approached for enrollment who consented and were successfully randomized. Of 72 patients approached for enrollment, 40 were randomized.
Measured: At time of enrollment and randomization (baseline)

Secondary outcomes (2)

Protocol Adherence
Protocol adherence defined as receipt of the intraoperative transesophageal echocardiography strategy corresponding to randomized assignment.
Measured: During index surgical procedure (from induction of anesthesia to completion of surgery; typical duration approximately 5-8 hours)
Rescue Echocardiography Use in the Backup TEE Arm
Use of rescue transesophageal echocardiography among participants randomized to the Backup TEE strategy, defined as intraoperative TEE performed in response to a clinical indication per protocol. Of 20 participants randomized to Backup TEE, 3 (15%) received rescue TEE.
Measured: During index surgical procedure (from induction of anesthesia to completion of surgery; typical duration approximately 5-8 hours)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

22 Jan 202415 Mar 2026

First posted4 Dec 2023
Study start22 Jan 2024
Primary completion15 Mar 2025
Study completion15 Mar 2026

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Heart DiseasesStudies of the same condition, open and under way.
More trials run by University of PennsylvaniaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Model description: (1) Default TEE: Where the TEE probe is placed after going under general anesthesia and a breathing tube is placed. TEE issued to take pictures of your heart before and after the CABG surgery. The TEE probe will remain in place throughout the surgery. (2) As-Needed TEE: Where the TEE probe is placed only in situations where a surgeon requires information that can only be obtained by ultrasound imaging of the heart.
Masking: None (open label)
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06154265
Sponsor's protocol ID: 853364
Status last verified: Apr 2026
First submitted: 13 Nov 2023
Last updated: 12 May 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Default vs As-Needed Intraoperative Transesophageal Echocardiography (TEE) in Low-Risk Isolated Coronary Artery Bypass Graft (CABG) Surgery: A Randomized Controlled Trial
ClinicalTrials.gov ID: NCT06154265
Acronym / sponsor ID: 853364
Conditions: Heart Diseases, Coronary Artery Disease, Chest Pain, Stenosis Coronary, STEMI
Keywords: Heart, Chest Pain, Artery, Stenosis, TEE, CABG, Bypass
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: University of PennsylvaniaUniversity, hospital or other
Collaborators: National Institutes of Health (NIH)
Study start: 22 Jan 2024 (actual)
Primary completion: 15 Mar 2025 (actual)
Study completion: 15 Mar 2026 (actual)
First posted: 4 Dec 2023 (actual)
Results: Posted 12 May 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: (1) Default TEE: Where the TEE probe is placed after going under general anesthesia and a breathing tube is placed. TEE issued to take pictures of your heart before and after the CABG surgery. The TEE probe will remain in place throughout the surgery. (2) As-Needed TEE: Where the TEE probe is placed only in situations where a surgeon requires information that can only be obtained by ultrasound imaging of the heart.

Arm	Type	Receives
Default TEE	Active comparator	Device: TEE probeThe TEE probe is placed after going under general anesthesia and a breathing tube is placed. TEE issued to take pictures of the heart before and after a CABG surgery. If randomized to this group, the TEE probe will remain in place throughout the surgery.
As-needed TEE	Other	Device: TEE probeThe TEE probe is placed only in situations where a surgeon requires information that can only be obtained by ultrasound imaging of the heart.

Who may qualify

Ages: 18 to 100 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Scheduled to undergo isolated CABG surgery at a hospital within the UPenn Health System
Age ≥18 years
Ejection fraction ≥50%
Transthoracic echocardiography within one year of scheduled surgery date
Left heart catheterization within one year of scheduled surgery date

Key exclusion criteria (33 listed)

Documented valve (aortic, mitral, tricuspid, or pulmonic) disease (stenosis or regurgitation) moderate or greater.
Any CABG surgery with either "possible" or "definite" aortic intervention listed as a planned part of the procedure. plan for either definite or possible surgical intervention.
Any CABG surgery with either "possible" or "definite" valve repair/replacement listed as a planned part of the procedure.
Having undergone any previous cardiac surgeries (i.e. scheduled with a "REDO" modifier).
Proximal/critical left main coronary disease (e.g. greater than or equal to 90% stenosis).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
TEE probeAlso: Philips transesophageal echocardiography (TEE), ultrasound probeTransesophageal echocardiography, ultrasound probe	Device	As-needed TEE, Default TEE

Primary outcome

Enrollment and Randomization Feasibility
Time frame: At time of enrollment and randomization (baseline)
Enrollment and randomization feasibility defined as the proportion of patients approached for enrollment who consented and were successfully randomized. Of 72 patients approached for enrollment, 40 were randomized.

2 secondary outcomes

Protocol Adherence
Time frame: During index surgical procedure (from induction of anesthesia to completion of surgery; typical duration approximately 5-8 hours)
Rescue Echocardiography Use in the Backup TEE Arm
Time frame: During index surgical procedure (from induction of anesthesia to completion of surgery; typical duration approximately 5-8 hours)

Results and safety

Results posted to the registry on 12 May 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Default TEE	20	20
Backup TEE	20	20

Primary outcome: Enrollment and Randomization Feasibility

Time frame: At time of enrollment and randomization (baseline). Count of participants. Unit: Participants

Measure	Overall Enrollment Cohort n = 72
Value	40

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: From index procedure through last available follow-up, including events occurring beyond the planned 90-day postoperative period (up to 185 days). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Default TEE	2 of 21 (9.5%)	0 of 21 (0%)	0 of 21
Backup TEE	1 of 19 (5.3%)	0 of 19 (0%)	1 of 19

Limitations and caveats (from the sponsor): This two-hospital feasibility trial was not powered to detect differences in clinical outcomes. The small sample size and limited follow-up preclude conclusions regarding the safety or effectiveness of either arm. Findings are intended to inform the design and conduct of a larger multicenter trial. The term "Backup TEE" used in this record corresponds to the "As-needed TEE" strategy described in the IRB-approved protocol and the "TEE-on-Demand" strategy used in the manuscript.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Emily MacKay, DO, MS principal investigator

University of Pennsylvania, Penn Medicine

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing TEE probe in people with Heart Diseases and Coronary Artery Disease, run by University of Pennsylvania at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Enrollment and Randomization Feasibility (time frame: At time of enrollment and randomization (baseline)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06154265.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2026; AzTrials last refreshed its copy on 26 Oct 2026.