NCT05577195

Brief Summary

Prospective, multi-center, randomized (1:1), controlled trial of Impella for active left ventricular unloading on top of veno-arterial extracorporeal membrane oxygenation vs. veno-arterial extracorporeal membrane oxygenation alone for the treatment of cardiogenic shock.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
198

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

October 10, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 13, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

November 17, 2022

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

December 29, 2022

Status Verified

December 1, 2022

Enrollment Period

2 years

First QC Date

October 10, 2022

Last Update Submit

December 28, 2022

Conditions

Cardiogenic Shock

Keywords

Active left ventricular unloadingVA-ECMOImpellaCardiogenic shock

Outcome Measures

Primary Outcomes (1)

  • Time to death from any-cause within 30 days after randomization

    Time to death from any-cause within 30 days after randomization

    30 days

Secondary Outcomes (10)

  • Death from any-cause at 6 and 12 months as well as time to death at these time points

    6 and 12 months

  • Cardiovascular death at day 30, 6 months and 12 months as well as time to death at these time points

    30 days, 6 and 12 months

  • Length of veno-arterial extracorporeal membrane oxygenation therapy, mechanical ventilation, inotrope therapy and stay at the intensive care unit (in days).

    12 months

  • Days free from veno-arterial extracorporeal membrane oxygenation therapy in 30 days

    30 days

  • Need for renal replacement therapy until day 30, 6 months and 12 months

    30 days, 6 and 12 months

  • +5 more secondary outcomes

Study Arms (2)

Impella + VA-ECMO

EXPERIMENTAL
Device: ImpellaDevice: VA-ECMO

VA-ECMO only

ACTIVE COMPARATOR
Device: VA-ECMO

Interventions

ImpellaDEVICE

To provide active left ventricular unloading in the experimental arm

Impella + VA-ECMO
VA-ECMODEVICE

To provide circulatory support in both arms

Impella + VA-ECMOVA-ECMO only

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Severe cardiogenic shock due to severe left ventricular dysfunction:
  • Systolic blood pressure \<90 mmHg or need for catecholamines to maintain such blood pressure
  • Signs of impaired organ perfusion with at least one of the following: altered mental status OR cold, clammy skin OR oliguria with urine output \<30 ml/h
  • Arterial lactate \>5 mmol/l

You may not qualify if:

  • Post-cardiotomy cardiogenic shock.
  • Cardiogenic shock due to acute rejection in heart transplant recipients.
  • Obstructive cardiogenic shock (e.g. cardiogenic shock due to fulminant pulmonary embolism)
  • Cardiogenic shock due to other causes (e.g. bleeding, hypothermia)
  • Pre-existing Impella treatment.
  • Onset of shock \>12 hours.
  • Mechanical complication of acute myocardial infarction.
  • Prolonged resuscitation (\>60 minutes).
  • Severe peripheral artery disease with infeasibility for Impella or veno-arterial extracorporeal membrane oxygenation implantation.
  • Age \<18 or \>80 years.
  • Other severe concomitant disease with life expectancy \<6 months.
  • Participation in another trial with an intervention or pregnancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Heart and Vascular Center Hamburg

Hamburg, 20251, Germany

RECRUITING

Related Publications (1)

  • Schrage B, Sundermeyer J, Blankenberg S, Colson P, Eckner D, Eden M, Eitel I, Frank D, Frey N, Graf T, Kirchhof P, Kupka D, Landmesser U, Linke A, Majunke N, Mangner N, Maniuc O, Mierke J, Mobius-Winkler S, Morrow DA, Mourad M, Nordbeck P, Orban M, Pappalardo F, Patel SM, Pauschinger M, Pazzanese V, Radakovic D, Schulze PC, Scherer C, Schwinger RHG, Skurk C, Thiele H, Varshney A, Wechsler L, Westermann D. Timing of Active Left Ventricular Unloading in Patients on Venoarterial Extracorporeal Membrane Oxygenation Therapy. JACC Heart Fail. 2023 Mar;11(3):321-330. doi: 10.1016/j.jchf.2022.11.005. Epub 2023 Jan 11.

    PMID: 36724180DERIVED

MeSH Terms

Conditions

Shock, Cardiogenic

Condition Hierarchy (Ancestors)

Myocardial InfarctionMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisShock

Central Study Contacts

Dirk Westermann, Prof.

CONTACT

0049 40 7410 0d.westermann@uke.de

Benedikt Schrage, Dr.

CONTACT

b.schrage@uke.de

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 10, 2022

First Posted

October 13, 2022

Study Start

November 17, 2022

Primary Completion

November 30, 2024

Study Completion

December 1, 2025

Last Updated

December 29, 2022

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)