← Back to Search

Intraoperative Echocardiography for Heart Disease

N/A

Waitlist Available

Led By Emily MacKay, DO, MS

Research Sponsored by University of Pennsylvania

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age ≥18 years

Scheduled to undergo isolated CABG surgery at PPMC

Must not have

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 month

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to determine which CABG patients need TEE during surgery to improve outcomes.

Who is the study for?

This trial is for adults over 18 who are scheduled for low-risk isolated CABG surgery, have a good heart pump function (ejection fraction ≥50%), and recent heart tests. It's not for those with moderate or severe valve disease, planned aortic interventions, critical coronary disease, end-stage kidney disease on dialysis, certain esophageal conditions, or severe pulmonary hypertension.

What is being tested?

The study aims to determine the usefulness of using an intraoperative TEE probe during CABG surgeries. The TEE probe is used to take detailed images of the heart from inside the esophagus during surgery to guide decisions and improve outcomes.

What are the potential side effects?

While not explicitly stated in this summary, potential side effects of using a TEE probe may include sore throat, difficulty swallowing or rare complications like esophageal injury.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 18 years old or older.

Select...

I am scheduled for a heart bypass surgery at PPMC.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have moderate or severe heart valve disease.

Select...

I am scheduled for CABG surgery that may include work on my aorta.

Select...

I have had severe heart or blood pressure issues after a specific medical procedure.

Select...

I cannot have an echocardiogram due to past esophageal surgery or injury.

Select...

I have severe narrowing in my heart's main artery.

Select...

I am on hemodialysis for end-stage kidney disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 month

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 month

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 month for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Primary Objectives

Secondary study objectives

Secondary Objectives

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: As-needed TEEExperimental Treatment1 Intervention

The TEE probe is placed only in situations where a surgeon requires information that can only be obtained by ultrasound imaging of the heart.

Group II: Default TEEActive Control1 Intervention

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.

0 / 8Eligibility criteria met