NCT05426083 · University of Minnesota
Left Ventricular Physiological Effects of Veno-Arterial Extracorporeal Membrane Oxygenation Support During Cardiogenic Shock
What this study is about
A Clinical Events Committee (CEC) will include Cardiac Surgery Professor and chief of cardiac surgery Rose Kelly MD, Professor of Medicine Ganesh Raveendran MD at the University of Minnesota who is the direction of Interventional Cardiology and Professor of Medicine at the University of Minnesota David Benditt.
View original scientific description
A Clinical Events Committee (CEC) will include Cardiac Surgery Professor and chief of cardiac surgery Rose Kelly MD, Professor of Medicine Ganesh Raveendran MD at the University of Minnesota who is the direction of Interventional Cardiology and Professor of Medicine at the University of Minnesota David Benditt. They will review and adjudicate serious and unexpected adverse events independently from the PI and co investigators.
Interventions
OTHER
Physiological Assessment
Observational only
Primary outcome measures
Pressure-volume loops at the highest level of VA-ECMO support and the lowest level of VA-ECMO support.
Time frame: Day 3 of ECMO
Pressure-volume loops at the highest level of VA-ECMO support and the lowest level of VA-ECMO support.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Age 18-75 years
- SCAI D/E CS requiring VA-ECMO support based on treating team's judgement.
- MAP \>65 mmHg on \<3 vasopressors/inotropes at the time of consent
- Cardiogenic shock due to acute coronary syndrome identified by coronary angiography at the index hospitalization per standard cardiology practice
Exclusion criteria
- VA-ECMO for sepsis, pulmonary embolism, COVID-19 related cardiorespiratory failure, severe RV failure due to severe idiopathic pulmonary hypertension
- CS due to other (non-ACS) etiologies
- Known patient with severe left ventricular dysfunction and stage IV NYHA heart failure being evaluated for or with a history of LVAD and transplantation prior to commencement of VA-ECMO
- Profound vasoplegia with MAP \<65 mmHg on 3 vasopressors/inotropes
- Moderate to severe aortic regurgitation (contraindication to VA-ECMO)
- Moderate to severe aortic stenosis (contraindication to LV instrumentation with PV loop catheter)
- Bleeding complications requiring ongoing transfusions of blood products
- Ischemic lower extremities
- Evidence of circuit thrombosis or fibrin accumulation (turndown increases risk for stroke and clot formation)
- Evidence of sepsis or septic shock
- Evidence of LV thrombus on echocardiography (contraindication for accessing LV cavity with catheters)
Where
- Minneapolis, Minnesota
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 3, 2025 · Source of record for eligibility and locations