Comparing VA ECMO with and without left ventricular unloading in cardiogenic shock patients
Physiology of Unloading VA ECMO Trial
PHASE2 · University of Utah · NCT06336655
This study is testing if adding a device to help the heart pump better while on a life-support machine can improve recovery for people in cardiogenic shock.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 104 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Utah (other) |
| Locations | 1 site (Salt Lake City, Utah) |
| Trial ID | NCT06336655 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effects of adding left ventricular unloading to veno-arterial extracorporeal membrane oxygenation (VA ECMO) in patients experiencing cardiogenic shock. Participants will be randomized to receive either standard VA ECMO or VA ECMO combined with an intra-aortic balloon pump (IABP) for LV unloading. The study will assess physiological changes, myocardial function, and recovery outcomes through various measurements, including lab work and echocardiography. The goal is to determine if LV unloading improves patient outcomes compared to VA ECMO alone.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older diagnosed with acute cardiogenic shock who are failing medical therapy.
Not a fit: Patients with metastatic cancer, planned LV unloading on ECMO, or those who are pregnant may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance recovery and survival rates in patients with cardiogenic shock.
How similar studies have performed: Preliminary data suggests that LV unloading may improve survival in similar patient populations, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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: 1. Society for Coronary Angiography and Interventions (SCAI) Stage C or greater 2. 2 or more inotropic medications and not improving 3. IABP in place and clinically worsening 4. Placed on VA ECMO for CS 5. In the opinion of the attending physician, patient has worsening CS and could require VA ECMO support in the near-term Exclusion Criteria: * Metastatic or stage 4 cancer * 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
Where this trial is running
Salt Lake City, Utah
- University of Utah — Salt Lake City, Utah, United States (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Cardiogenic Shock, cardiogenic shock, extracorporeal membrane oxygenation, left ventricular unloading