Not medical advice. This website is not medical advice, a diagnosis, a match to a trial, or a recommendation to join a study. Listings are plain-English rewrites of public ClinicalTrials.gov records. Whether a site is still enrolling, and whether you qualify, can only be confirmed by the study team and your clinician. Source registry: ClinicalTrials.gov. Editorial rules: methodology.
PlainTrials
RecruitingNot a traditional drug phaseinterventionalRules rewrite

Not a traditional drug phase: Microaxial flow pump (left ventricular assist device) for Cardiogenic Shock

The goal of this clinical trial is to learn which treatment strategies improve survival in adult patients with acute myocardial infarction complicated by cardiogenic shock (AMI-CS). The main questions it aims to answer are: * Does the immediate use of a left-sided microaxial flow pump (Impella) after percutaneous coronary intervention (PCI) improve survival compared to initial medical therapy alone?

Official registry: https://clinicaltrials.gov/study/NCT07762560 · Leipzig Heart Science gGmbH · enrollment listed as 780

What this phase means

This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Microaxial flow pump (left ventricular assist device), Pulmonary artery catheter, or Conventional hemodynamic monitoring. The registry lists allocation as randomized. The goal of this clinical trial is to learn which treatment strategies improve survival in adult patients with acute myocardial infarction complicated by cardiogenic shock (AMI-CS).

They plan to enroll about 780 people at Leipzig. Taking part typically means using or being fitted with a device, a procedure as part of the study plus check-ins.

Official title (unrewritten)

Routine Microaxial Flow Pump Versus Radial Access Revascularization Without Routine Microaxial Flow Pump in Infarct-Related Cardiogenic Shock & Routine Pulmonary Artery Catheterization-based Monitoring With Protocolized Hemodynamic Optimization Versus Simplified Monitoring Without Protocolized Hemodynamic Optimization in Infarct-Related Cardiogenic Shock

Interventions: Microaxial flow pump (left ventricular assist device), Pulmonary artery catheter, Conventional hemodynamic monitoring, Hemodynamic stabilization

Primary outcome (registry wording): all-cause death

Who it is for (from inclusion criteria)

  • Ages 18 Years to 80 Years
  • Cardiogenic shock complicating AMI (STEMI or NSTEMI) plus obligatory all 4 of these:
  • Planned immediate angiography and revascularization (preferred PCI)
  • Systolic blood pressure \<100 mmHg or catecholamines required to maintain pressure \>90 mmHg during systole
  • Arterial lactate \>2.0 mmol/L
  • Echocardiogram with LVEF \<40% or left ventricular outflow tract velocity time integral (LVOT-VTI) ≤12 cm

Public study contact (from the registry)

DOUBLE SHOCK Leipzig Heart Science gGmbH

+49 341 865 251542

DOUBLE-SHOCK@leipzig-heart.de

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

1 listed

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FAQ about this NCT record

Is NCT07762560 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07762560?

Not a traditional drug phase. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07762560?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary