NCT06872021

Brief Summary

The goal of this multicenter, randomized trial is to compare early early left ventricular unloading by Intra-aortic Balloon Pump (IABP) versus conventional approach in patients with cardiogenic shock (CS) undergoing venoarterial extracorporeal membrane oxygenation (VA-ECMO). The main question it aims to answer is : • If left ventricular unloading by IABP as compared with the conventional approach will improve the outcomes in patients undergoing VA-ECMO.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
358

participants targeted

Target at P75+ for not_applicable

Timeline
29mo left

Started Mar 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress14%
Mar 2026Dec 2028

First Submitted

Initial submission to the registry

March 3, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 12, 2025

Completed
1 year until next milestone

Study Start

First participant enrolled

March 22, 2026

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2028

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Last Updated

March 24, 2026

Status Verified

March 1, 2026

Enrollment Period

2.4 years

First QC Date

March 3, 2025

Last Update Submit

March 22, 2026

Conditions

ECMO

Keywords

ECMOIABPLV unloading

Outcome Measures

Primary Outcomes (1)

  • 30-day mortality

    30 days

Secondary Outcomes (20)

  • weaning from VA-ECMO

    30 days

  • Rate of advanced mechanical unloading

    30 days

  • Left Ventricular Function of survivors

    30 days

  • In-hospital Mortality

    30 days

  • Day of Mechanical Circulatory Support Device Weaning

    30 days

  • +15 more secondary outcomes

Study Arms (2)

ECMO+IABP group

EXPERIMENTAL

Patients receive IABP for left ventricular unloading within 6 hours after VA-ECMO initiation.

Other: Early IABP use

ECMO group

ACTIVE COMPARATOR

Patients do not receive mechanical unloading within 6 hours after VA-ECMO initiation.

Other: Conventional approach

Interventions

Early IABP useOTHER

Patients receive IABP for left ventricular unloading within 6 hours after VA-ECMO initiation.

ECMO+IABP group
Conventional approachOTHER

Patients do not receive mechanical unloading within 6 hours after VA-ECMO initiation.

ECMO group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age of ≥18
  • Cardiogenic shock(defined as a systolic blood pressure of less than 90 mm Hg for more than 30 minutes or the initiation of catecholamines to maintain a systolic pressure of more than 90 mm Hg, an arterial lactate level of more than 3 mmol per liter, and signs of impaired organ perfusion)
  • Successful implantation of VA-ECMO
  • Informed consent

You may not qualify if:

  • SCAI shock stage A or B
  • Presence of moderate to severe aortic insufficiency or aortic dissection
  • Severe peripheral vascular disease
  • Post-cardiotomy cardiogenic shock(non-CABG procedure) or bridging to cardiac procedure(heart transplantation or LVAD).
  • VA-ECMO for definite non-cardiac causes
  • Isolated right ventricular failure
  • V-A ECMO usage confined to the period during surgery or other interventions
  • Ischemic mechanical complications(eg Ventricular septal defect, papillary muscle rupture)
  • Extracorporeal cardiopulmonary resuscitation
  • LVAD, Impella or IABP in situ.
  • Severe bleeding
  • Terminal malignancy
  • Irreversible neurologic injury
  • Pregnancy or lactation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Anzhen Hospital

Beijing, Beijing Municipality, 100029, China

RECRUITING

Study Officials

  • Xiaotong Hou, MD, PhD

    Beijing Anzhen Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaotong Hou, MD, PhD

CONTACT

010-64456631xt.hou@ccmu.edu.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 3, 2025

First Posted

March 12, 2025

Study Start

March 22, 2026

Primary Completion (Estimated)

September 1, 2028

Study Completion (Estimated)

December 1, 2028

Last Updated

March 24, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)