Evaluating early implantation of a heart pump in patients with severe heart issues
Evaluation of the Efficacy of Early Implantation of a Percutaneous Left Ventricular Assist Devices in Acute Coronary Syndrome Complicated by Cardiogenic Shock Compared to Conventional Therapy: a Prospective, Multicenter, Randomized, Controlled and Open-label Clinical Trial
This study is testing if putting in a heart pump early can help people with severe heart problems from a heart attack feel better and live longer compared to just standard treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 204 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Assistance Publique Hopitaux De Marseille Academic / other |
| Locations | 1 site (Marseille, Bouche DU Rhone) |
| Trial ID | NCT05366452 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 80 who are experiencing acute coronary syndrome with cardiogenic shock.
Not a fit: Patients with significant femoral artery stenosis or other contraindications to the heart pump implantation may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve survival rates and quality of life for patients suffering from severe heart failure due to cardiogenic shock.
How similar studies have performed: Other studies have shown promising results with similar heart pump interventions in acute heart failure settings, suggesting potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Marseille, Bouche DU Rhone
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.