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RECRUITING

Left Ventricular Physiological Effects of Veno-Arterial Extracorporeal Membrane Oxygenation Support During Cardiogenic Shock

NCT05426083•University of Minnesota

Summary

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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
+1 more criteria

Locations (1)

University of Minnesota

Minneapolis, Minnesota, United States

Key Dates

Start Date

August 4, 2022

Primary Completion Date

December 31, 2026

Completion Date

December 31, 2026

Last Updated

August 3, 2025

Enrollment

200

ESTIMATED participants

Conditions

Acute Coronary SyndromeCardiogenic Shock

Interventions

Physiological Assessment

OTHER

Contacts

Julie Longman

CONTACT

612-625-5949 longm021@umn.edu

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 3, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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Left Ventricular Physiological Effects of Veno-Arterial Extracorporeal Membrane Oxygenation Support During Cardiogenic Shock

Inclusion Criteria

Exclusion Criteria

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