NCT06336655RecruitingPhase 2
Physiology of Unloading VA ECMO Trial
Source: ClinicalTrials.gov · Last updated 30 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 104 (estimated)
- First submitted
- 8 Mar 2024
- Start date
- 2 Oct 2024
- Primary completion date
- 1 Feb 2028
- Lead sponsor
- University of Utah
- NCT number
- NCT06336655
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 104
- From 2 Oct 2024 to the primary completion date, 1 Feb 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Metastatic or stage 4 cancer
Other
- Atrial septostomy
- Planned LV unloading on ECMO
- Anticipated death \<72 hours
- Existing durable left ventricular assist device (dLVAD)
- Unwillingness to randomize
- Patients who are pregnant
Who the study is looking for
- Adult patients (age 18 years or older)
- Diagnosis of acute cardiogenic shock (CS)
- Patients failing medical therapy, defined as 1 or more of the following:
- Society for Coronary Angiography and Interventions (SCAI) Stage C or greater
- 2 or more inotropic medications and not improving
- IABP in place and clinically worsening
- Placed on VA ECMO for CS
- In the opinion of the attending physician, patient has worsening CS and could require VA ECMO support in the near-term
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Utah Coordinator of this site? Confirm its status | Salt Lake City | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.