RECRUITINGOBSERVATIONAL
Left Ventricular Physiological Effects of Veno-Arterial Extracorporeal Membrane Oxygenation Support During Cardiogenic Shock
About This Trial
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.
Who May Be Eligible (Plain English)
Who May Qualify:
- 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
Who Should NOT Join This Trial:
- 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)
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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)
Treatments Being Tested
OTHER
Physiological Assessment
Observational only
Locations (1)
University of Minnesota
Minneapolis, Minnesota, United States