The RECOVER IV Trial

Cardiogenic Shock Clinical Trial

— RECOVER IV  

Official title:

Early Impella® Support in Patients With ST-Segment Elevation Myocardial Infarction Complicated by Cardiogenic Shock: The RECOVER IV Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05506449
• Other study ID #: ABMD-CIP-22-02
• Status: Recruiting
• Phase: N/A
• Start date: October 28, 2023
• Est. completion date: December 30, 2027

Study information

• Verified date: January 2024
• Source: Abiomed Inc.
• Contact: Sameera Dasari, PhD
• Phone: 978-914-8882
• Email: sdasari[@]abiomed.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to assess whether hemodynamic support with an Impella-based treatment strategy initiated prior to percutaneous coronary intervention (PCI) in patients with ST-Segment Elevation Myocardial Infarction (STEMI)-Cardiogenic Shock (CS) improves survival and functional outcomes compared to a non-Impella-based treatment strategy.

Description:

To demonstrate that hemodynamic support with an Impella-based treatment strategy initiated prior to PCI, when compared with a non-Impella-based standard of care treatment strategy reduces all-cause mortality at 30 days in patients with STEMI-CS.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 560
• Est. completion date: December 30, 2027
• Est. primary completion date: April 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

1. Cardiogenic shock with onset =12 hours after STEMI and prior to index PCI, as defined by having both the following:

1. Persistent SBP <90 mmHg for =30 minutes despite fluid resuscitation or pressors/inotropes required to maintain SBP =90 mmHg and

2. Signs of impaired organ perfusion (cool extremities and/or altered mental status)

2. One of the following must be present on a standard 12-lead electrocardiogram (ECG):

1. ST-segment elevation (=2 mm elevation of ST-segments in =2 contiguous leads without left bundle branch block) or

2. Anterior (V1-V4) ST-segment depression =2 mm in =2 contiguous leads consistent with a possible posterior infarction AND coronary angiogram prior to randomization showing acute total or subtotal occlusion of the proximal circumflex artery or

3. aVR ST-segment elevation =2 mm without anterior ST-segment elevation AND coronary angiogram prior to randomization confirming left main culprit lesion

• NOTE: Patients with isolated RV infarction are excluded from this Protocol. If a patient qualifies with cardiogenic shock with only inferior ST-segment elevation, pre-randomization assessment of LV function must be obtained with either point of care echocardiography or contrast left ventriculography to demonstrate a LVEF =40% for the patient to be eligible for randomization.

3. Intended emergent PCI to treat the STEMI

4. Subject is able to and agrees to provide written informed consent. If the subject is unable to be consented because of their extreme illness and a legally authorized representative (LAR) is present, the LAR must agree and provide written informed consent. If the subject is unable to provide consent because of their extreme illness and an LAR is not present, the patient may be randomized under Exception from Informed Consent (EFIC) Guidance

Exclusion Criteria:

1. High suspicion for isolated right ventricular infarct confirmed with ECG lead V4R

2. Cardiogenic shock with either of the following:

1. High-grade atrioventricular block (heart rate (HR) <50 bpm)

• NOTE: If patient is paced, via temporary or permanent pacemaker, and still in shock, they are still eligible

2. Isolated narrow complex supraventricular tachycardia with ventricular response >170 bpm or ventricular tachyarrhythmia with ventricular response >150 bpm

3. Known mechanical complications of acute myocardial infarction (AMI) that may cause cardiogenic shock such as free wall rupture, cardiac tamponade, ventricular septal defect or papillary muscle rupture with acute mitral regurgitation

4. Left ventricular function (LVEF >40%) on echocardiography or LV-gram (if performed) indicating shock due to another cause (e.g., RV infarction as the principal cause of shock, hypovolemia, sepsis or high cardiac output shock)

5. Severe bilateral peripheral arterial disease precluding femoral Impella CP insertion (femoral angiogram required) NOTE: Impella insertion via a non-femoral arterial route is not permitted in this Protocol.

6. IABP, Impella or other mechanical circulatory support already in place for present indication (pre-randomization)

7. Known end-stage renal disease, receiving dialysis

8. Severe aortic stenosis, or moderate or worse aortic regurgitation or prior self-expanding transcatheter aortic valve replacement (TAVR), or surgically placed mechanical valve, if known

9. Acute or chronic aortic dissection, if known

10. Large or mobile LV thrombus, if known

11. Prior PCI for the present infarction

12. Prior PCI or coronary artery bypass graft (CABG) within 1 year, if known

13. Ongoing cardiopulmonary resuscitation (CPR)

14. Not obeying verbal commands after preadmission or in-hospital cardiac arrest

• NOTE: (i) A positive and appropriate response to commands must be repeatable on at least two (2) instances to rule out reflex response to voice (ii) Intubated subjects may be enrolled if:

1. They did not have a cardiac arrest and were following verbal commands prior to intubation or

2. They are clearly following verbal commands after intubation

15. Prior stroke with permanent, significant neurological defect

16. Prior intracranial hemorrhage or known intracerebral mass, aneurysm or fistula

17. Acute or suspected stroke prior to randomization

18. Active infection requiring oral or intravenous antibiotics

19. Prior heparin-induced thrombocytopenia, if known

20. Other severe, concomitant disease with limited life expectancy <1 year (other than cardiogenic shock)

21. Pregnancy, known or suspected

22. Participation in the active treatment or follow-up phase of another clinical study of an investigational drug or device that has not reached its primary endpoint or any cardiogenic shock trial other than a registry

23. If known, subject has previously been symptomatic with or hospitalized for COVID-19 unless he/she has been discharged (if hospitalized) and asymptomatic for =4 weeks and has returned to his/her prior baseline (pre-COVID) clinical condition

24. Subject has other medical, social or psychological conditions that, in the opinion of the Investigator, compromises the subject's ability to comply with study procedures (e.g., dementia, severe alcohol or substance abuse)

25. Patient belongs to a vulnerable population [Vulnerable patient populations may include individuals with mental disability, persons in nursing homes, impoverished persons, homeless persons, nomads, refugees and those permanently incapable of giving informed consent. Vulnerable populations also may include members of a group with a hierarchical structure such as university students, subordinate hospital and laboratory personnel, employees of the Sponsor, members of the armed forces and persons kept in detention]

26. Patient is wearing a bracelet or other item indicating their wishes to decline participation in the study

Related Conditions & MeSH terms

• Cardiogenic Shock
• Infarction
• Myocardial Infarction
• Shock
• Shock, Cardiogenic
• ST Elevation Myocardial Infarction
• ST-segment Elevation Myocardial Infarction (STEMI)

Intervention

Device:
• Impella CP®
Subjects randomized to the Treatment Arm will undergo Impella CP placement prior to PCI. Right heart catheterization will be performed prior to or immediately after PCI. Use of IABP will not be allowed in the Treatment Arm.

Other:
• Standard of Care
This may include inotropes and/or vasopressors. An IABP may or may not be used according to local practice and the specific condition of each individual patient. If an IABP is used, it may be placed prior to or after PCI, and its timing of explant is left to the discretion of the Investigator.

Locations

Country	Name	City	State
Germany	Herzzentrum Dresden	Dresden	Saxony
United States	New Mexico Heart Institute	Albuquerque	New Mexico
United States	Presbyterian Healthcare Services	Albuquerque	New Mexico
United States	Tufts Medical Center	Boston	Massachusetts
United States	Henry Ford Health System	Detroit	Michigan
United States	Dignity Health Chandler Regional Medical Center	Gilbert	Arizona
United States	Hackensack University Medical Center	Hackensack	New Jersey
United States	Allegheny General Hospital	Pittsburgh	Pennsylvania
United States	UPMC Presbyterian	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Abiomed Inc.

Countries where clinical trial is conducted

United States,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	All-Cause Mortality		At hemodynamic stability and when the subject is no longer hospitalized, 6 Months, 1 Year
Other	MACCE		At hemodynamic stability when the subject is no longer hospitalized, 6 Months, 1 Year
Other	Days Alive Out-of-Hospital		30 Days, 6 Months
Other	Mean Change in Health-Related Quality of Life, as measured by Kansas City Cardiomyopathy Questionnaire		30 Days Post-Discharge, 6 Months
Other	Mean Change in Health-Related Quality of Life, as measured by Rose Dyspnea Score		30 Days Post-Discharge, 6 Months, 1 Year
Other	Mean Change in Health-Related Quality of Life, as measured by EQ-5D-5L		30 Days Post-Discharge, 6 Months, 1 Year
Other	Left Ventricular Ejection Fraction (LVEF)		30 Days, 6 Months
Other	Estimated Glomerular Filtration Rate (eGFR)		At hemodynamic stability when the subject is no longer hospitalized, 30 Days, 6 Months, 1 Year
Other	Number of Participants with need for In-Hospital Hemodialysis or Continuous Renal Replacement Therapy (CRRT)		At hemodynamic stability when the subject is no longer hospitalized
Other	Number of Participants with need for Dialysis Post-Index Hospitalization		30 Days, 6 Months, 1 Year
Other	Number of Participants with any Dialysis		30 Days, 6 Months, 1 Year
Other	All-Cause Hospitalizations		30 Days, 6 Months, 1 Year
Other	Cardiovascular Hospitalizations		30 Days, 6 Months, 1 Year
Other	Heart Failure Hospitalizations		30 Days, 6 Months, 1 Year
Other	Number of Participants with new Implantable Cardioverter Defibrillator (ICD) or Cardiac Resynchronization Therapy (CRT) Implant		At hemodynamic stability when the subject is no longer hospitalized, 30 Days, 6 Months, 1 Year
Other	Number of Participants with Left Ventricular Assist Device (LVAD) or Heart Transplant (including United Network for Organ Sharing (UNOS) 1/2 listing)		At hemodynamic stability when the subject is no longer hospitalized, 30 Days, 6 Months, 1 Year
Other	Repeat Target Vessel Revascularization (TVR)		30 Days, 6 Months, 1 Year
Other	Acute Kidney Injury (AKI)		within 7 Days Post-Percutaneous Coronary Intervention (PCI)
Other	Disability Assessed using the Modified Rankin Scale		At hemodynamic stability when the subject is no longer hospitalized, 30 Days, 6 Months, 1 Year
Other	30-day survival with mRS score =3		30 day
Other	Number of Participants with Neurologic Academic Research Consortium (NeuroARC) Type 1 Stroke		At hemodynamic stability when the subject is no longer hospitalized
Other	Major Bleeding		Shock Academic Research Consortium (SHARC) Types 3-5, At hemodynamic stability when the subject is no longer hospitalized
Other	Major Vascular Complications		SHARC Definition, At hemodynamic stability when the subject is no longer hospitalized
Other	Major Hemolysis		At hemodynamic stability when the subject is no longer hospitalized
Other	Major Cath Lab Complications	Intubation; new bradyarrhythmia requiring a temporary pacemaker; ventricular arrhythmias requiring cardioversion or defibrillation; persistent severe hypotension or heart failure requiring escalation beyond the randomized study devices (Impella CP in the Treatment Arm and intra-aortic balloon pump (IABP) in the Control Arm).	All adverse events will be recorded and documented through 1 year follow up or study completion
Other	All Stroke		At hemodynamic stability when the subject is no longer hospitalized
Other	Minor Bleeding		At hemodynamic stability when the subject is no longer hospitalized
Other	Minor Vascular Complications		At hemodynamic stability when the subject is no longer hospitalized
Other	Minor Hemolysis		At hemodynamic stability when the subject is no longer hospitalized
Primary	All-Cause Mortality		30 Days
Secondary	Major Adverse Cardiovascular and Cerebrovascular Events (MACCE)		30 Days
Secondary	Days Alive Out-of-Hospital		6 Months
Secondary	Mean Change in Health-Related Quality of Life, as measured by Kansas City Cardiomyopathy Questionnaire		1 Year