Evaluating early implantation of a heart pump in patients with severe heart issues

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to assess the effectiveness of early implantation of the IMPELLA CP device in patients experiencing acute coronary syndrome complicated by cardiogenic shock, compared to standard medical therapy. It is a randomized, multicenter, open-label trial where participants will be assigned to either receive the heart pump in addition to optimal medical care or to receive only the standard treatment. The study will measure various outcomes, including mortality, need for advanced heart support, and quality of life over a one-year period. Patients will be monitored closely for complications and overall heart function throughout the trial.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age between 18 and 80 years old;
* ACS ≤ 24 hours;
* Cardiogenic shock defined by:
* At least one criteria of low cardiac output defined by
* SBP ≤ 90 mmHg or the need to use inotropes/vasopressors in order to obtain SBP\> 90 mmHg
* CI ≤ 2.2L/min/m2
* At least one criteria of left overload defined by
* clinical (killip class ≥ 2),
* biological (NtproBNP \> 900pg/ml or BNP \> 400pg/ml),
* radiological
* non invasive or invasive hemodynamic evaluation
* At least one criteria of malperfusion defined by
* clinical (marbles, oliguria ≤ 0.5ml/min/kg, cold/clammy skin and extremities,..)
* biological approach (arterial lactate ≥ 2mmol/L, ScVO2 \< 60%)
* Stage C or D of the ACC classification of CS
* Revascularization by PCI intended after coronary angiography;
* Lack of significant femoral artery stenosis or other local contra-indication to a 14 Fr sheath;
* Signed informed consent (patient and/or family/relative) or emergency procedure
* Subject affiliated to or beneficiary of a social security system.

Exclusion Criteria:

* Persons referred in articles L.1121-5 to L.1121-8 and L.1122-2 of the Public Health Code:

  * Pregnant, parturient or breastfeeding woman
  * Person deprived of liberty for judicial or administrative decision
  * Adult person under legal protection (any form of public guardianship)
* Onset of shock \>24 hours
* CS not related to ACS
* Patient with prolonged cardiac arrest (\>5 mins)
* Contra-indications to Impella CP implantations:

  * Isolated right ventricular failure
  * LV thrombus
  * Mechanical aortic valve or heart constrictive device
  * Aortic valve stenosis or calcification (equivalent to an orifice area of 0.6cm2 or less)
  * Moderate to severe aortic insufficiency (echocardiographic assessment graded as ≥ 2)
  * Severe peripheral arterial disease precluding placement of the Impella system
  * Combined cardiorespiratory failure
  * Presence of an Atrial or Ventricular Septal Defect (including post infarctus VSD)
  * Left ventricular rupture Cardiac tamponade
* Mechanical complication of myocardial infarction
* Cerebral deficit with fixed dilated pupils or irreversible neurological pathology
* Anoxic brain injury
* Active bleeding
* Contra-indication to antiplatelet or anticoagulant therapy
* Life expectancy \< 1 year

Where it's running

• Assistance Publique Hopitaux de Marseille
  Marseille, Bouche DU Rhone, France Recruiting

Study contacts

• Principal investigator: Laurent Bonello — Assistance Publique Hopitaux De Marseille
• Study coordinator: Laurent BONELLO
• Email: laurent.bonello@ap-hm.fr
• Phone: 4 91 96 86 83

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Safety and Efficacy of an Extracorporeal Ventricular Assist System for Cardiogenic Shock

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• Left Ventricular Support and Advanced Monitoring in AMI–Cardiogenic Shock: Immediate Impella Use and PAC/Monitoring vs Standard Care

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• CRP Apheresis for infarct-related cardiogenic shock

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.