Physiology of Unloading VA ECMO Trial

NCT06336655 | Recruiting Phase 2 DMC FDA Device

• 1 other identifier: 153309
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

Brief Summary

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. 1.To determine the physiologic effects on cardiopulmonary congestion of adding LV unloading to VA ECMO
2. 2.To determine the effects on myocardial function of adding LV unloading to ECMO
3. 3.To test the effects on myocardial recovery of adding LV unloading to VA ECMO

Conditions

Cardiogenic Shock

Keywords

cardiogenic shock; extracorporeal membrane oxygenation; left ventricular unloading

Outcome Measures

Primary Outcomes (1)

• Change in pulmonary capillary wedge pressure

  Change in pulmonary capillary wedge pressure (PCWP) from ECMO start to ECMO day 5 (Day 5 - Baseline) with and without LV unloading

  ECMO start, ECMO day 5, ECMO decannulation up to 3 months, day of ICU discharge up to 6 months

Secondary Outcomes (14)

• Change in pulmonary artery diastolic pressure

  ECMO start, ECMO days 1-5, ECMO decannulation up to 3 months, day of ICU discharge up to 6 months

• Change in left ventricular end diastolic diameter

  ECMO start, ECMO day 5, ECMO decannulation up to 3 months, day of ICU discharge up to 6 months

• Change in N-terminal pro b-type natriuretic peptide

  ECMO start, ECMO days 1-5, ECMO decannulation up to 3 months, day of ICU discharge up to 6 months

• Hemodynamic stability

  ECMO start, ECMO day 5

• Global cardiovascular function

  ECMO start, ECMO days 1-5

Study Arms (2)

With LV Unloading

EXPERIMENTAL

Patients on VA ECMO who randomize to receive LV unloading

Device: IABP

Without LV Unloading

NO INTERVENTION

Patients on VA ECMO who randomize to receive no LV unloading

Interventions

IABP DEVICE

LV unloading via intra-aortic balloon pump (IABP)

Also known as: LV unloading

With LV Unloading

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Utah: lead
• University of Minnesota: collaborator

Study Sites (1)

University of Utah

Salt Lake City, Utah, 84132, United States

RECRUITING

MeSH Terms

Conditions

Shock, Cardiogenic

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Shock

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Division of Cardiothoracic Surgery

Study Record Dates

• First Submitted: March 8, 2024
• First Posted: March 29, 2024
• Study Start: October 2, 2024
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): February 1, 2029
• Last Updated: April 30, 2026

Record last verified: 2026-04

Locations

US (1)