Status:
RECRUITING
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
Lead Sponsor:
Assistance Publique Hopitaux De Marseille
Conditions:
Cardiogenic Shock
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
The ULYSS study is a randomized, multicenter, interventional and prospective open-label clinical trial. It aims to evaluate the efficacy of the addition of an early IMPELLA CP support on top of optima...
Detailed Description
Primary end-point The primary endpoint (efficacy endpoint) is defined by a composite endpoint assessed at 1 month: * All cause death; * Need for ECMO; * LVAD device implantation; * Heart transplant ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 19 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
204 Patients enrolled
Trial Details
Trial ID
NCT05366452
Start Date
December 19 2022
End Date
December 1 2026
Last Update
January 25 2023
Active Locations (1)
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1
Assistance Publique Hopitaux de Marseille
Marseille, Bouche DU Rhone, France, 13354