Heart Disease Trial, Recruiting NCT05366452 Sponsor: Assistance Publique Hopitaux De Marseille Condition: Heart Disease
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Heart Disease Trial, Recruiting

NCT05366452
Recruiting Not Applicable

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People aged between 18 and 80 years old
  • People who experienced an acute coronary syndrome (a serious heart event such as a heart attack) within the last 24 hours
  • People diagnosed with cardiogenic shock, meaning the heart is not pumping enough blood — shown by low blood pressure (at or below 90 mmHg, or requiring medications to keep it above that level) or low heart output measured by specific tests
  • People showing signs that the heart is under significant strain, confirmed through physical examination, blood tests, imaging, or heart monitoring
  • People showing signs that the body's organs are not receiving enough blood, such as low urine output, cold or clammy skin, or abnormal blood test results
  • People whose cardiogenic shock falls into Stage C or D of the ACC (American College of Cardiology) classification system (confirm with trial site)
  • People planned to have a procedure called PCI (a technique to open blocked heart arteries) after a coronary angiogram (an imaging test of the heart arteries)
  • People without significant narrowing or blockage in the femoral artery (the large artery in the groin) that would prevent insertion of the required medical device
  • People who have given signed consent, or where emergency consent procedures apply
  • People enrolled in a social security system in France

Who may not be able to join:

  • Women who are pregnant, in labour, or breastfeeding
  • People who are currently detained by a court or administrative order
  • Adults who are under any form of legal guardianship or protection
  • People whose shock began more than 24 hours ago
  • People whose cardiogenic shock is not caused by an acute coronary syndrome
  • People who experienced a cardiac arrest lasting more than 5 minutes
  • People for whom the Impella CP heart support device cannot safely be used, including those with: failure of only the right side of the heart; a blood clot in the left ventricle (heart chamber); a mechanical aortic heart valve or similar implanted device; severe narrowing or calcium build-up on the aortic heart valve; moderate to severe leaking of the aortic heart valve; severe blockages in the leg arteries that would prevent device placement; combined heart and lung failure; a hole between the heart's chambers (including one caused by a heart attack); or a tear in the heart wall or fluid pressing on the heart
  • People with a mechanical complication from a heart attack
  • People with severe and irreversible brain damage (confirmed with trial site)
  • People with brain injury caused by lack of oxygen
  • People with active (ongoing) bleeding
  • People who cannot safely take blood-thinning or anti-clotting medications
  • People with a life expectancy of less than one year

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 13 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Principal Investigator: François CREMIEUX, Assistance Publique Hopitaux De Marseille

Phone: 4 91 96 86 83

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Not Applicable
Registry
ClinicalTrials.gov
Start date
19 December 2022
Est. completion
1 June 2026

Where this trial is recruiting

🇫🇷 France

Primary endpoints

Number of death from all causes; The rate of ECMO placements; The rate of implementation of the LVAD device; The rate of cardiac transplants

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 13 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov