Actively Recruiting
Physiology of Unloading VA ECMO Trial
Led by University of Utah · Updated on 2026-04-30
104
Participants Needed
1
Research Sites
226 weeks
Total Duration
On this page
Sponsors
U
University of Utah
Lead Sponsor
U
University of Minnesota
Collaborating Sponsor
AI-Summary
What this Trial Is About
The goal of this clinical trial is to compare the use of veno-arterial extracorporeal membrane oxygenation (VA ECMO) with and without left ventricular (LV) unloading in patients being treated for cardiogenic shock (CS). The main aims of the study are: 1. To determine the physiologic effects on cardiopulmonary congestion of adding LV unloading to VA ECMO 2. To determine the effects on myocardial function of adding LV unloading to ECMO 3. To test the effects on myocardial recovery of adding LV unloading to VA ECMO Participants who are being treated with VA ECMO will be randomized to receive or not receive LV unloading in the form of an intra-aortic balloon pump (IABP). Over the course of the study, the investigators will obtain measurements via lab work, echocardiography, and pulmonary artery catheter that will allow comparison of the two groups.
CONDITIONS
Official Title
Physiology of Unloading VA ECMO Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patients age 18 years or older
- Diagnosis of acute cardiogenic shock
- Failing medical therapy defined by at least one of the following: SCAI Stage C or greater, use of 2 or more inotropic medications without improvement, worsening while on IABP, currently on VA ECMO for cardiogenic shock, or attending physician expects worsening requiring VA ECMO support soon
You will not qualify if you...
- Metastatic or stage 4 cancer
- Atrial septostomy
- Planned left ventricular unloading on ECMO
- Anticipated death within 72 hours
- Existing durable left ventricular assist device (dLVAD)
- Unwillingness to be randomized
- Pregnancy
AI-Screening
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Trial Site Locations
Total: 1 location
1
University of Utah
Salt Lake City, Utah, United States, 84132
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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