The RECOVER IV Trial

NCT05506449 | Terminated DMC FDA Device

• 1 other identifier: ABMD-CIP-22-02
• Study Type: interventional
• Target: 4
• Locations: 4 countries
• Sites: 7

Brief 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.

Conditions

ST-segment Elevation Myocardial Infarction (STEMI); Cardiogenic Shock

Keywords

Cardiovascular Diseases; Myocardial Infarction; Heart Failure; Exception From Informed Consent (EFIC); Cardiogenic Shock

Outcome Measures

Primary Outcomes (1)

• All-Cause Mortality

  30 Days

Secondary Outcomes (3)

• Major Adverse Cardiovascular and Cerebrovascular Events (MACCE)

  30 Days

• Days Alive Out-of-Hospital

  6 Months

• Mean Change in Health-Related Quality of Life, as measured by Kansas City Cardiomyopathy Questionnaire

  1 Year

Other Outcomes (29)

• All-Cause Mortality

  At hemodynamic stability and when the subject is no longer hospitalized, 6 Months, 1 Year

• MACCE

  At hemodynamic stability when the subject is no longer hospitalized, 6 Months, 1 Year

• Days Alive Out-of-Hospital

  30 Days, 6 Months

Study Arms (2)

Control Arm

ACTIVE COMPARATOR

Subjects randomized to the Control Arm will be treated based on recommendations for cardiogenic shock in the contemporary AHA/ACC/SCAI and ESC Practice Guidelines for STEMI and Heart Failure Management and local standard of care.

Other: Standard of Care

Treatment Arm

EXPERIMENTAL

Subjects randomized to the Treatment Arm will receive hemodynamic support using an Impella-based treatment strategy initiated prior to percutaneous coronary intervention (PCI).

Device: Impella CP®

Interventions

Impella CP® DEVICE

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.

Treatment Arm

Standard of Care OTHER

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.

Control Arm

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Cardiogenic shock with onset ≤12 hours after STEMI and prior to index PCI, as defined by having both the following:
• Persistent SBP \<90 mmHg for ≥30 minutes despite fluid resuscitation or pressors/inotropes required to maintain SBP ≥90 mmHg and
• Signs of impaired organ perfusion (cool extremities and/or altered mental status)
• One of the following must be present on a standard 12-lead electrocardiogram (ECG):
• ST-segment elevation (≥2 mm elevation of ST-segments in ≥2 contiguous leads without left bundle branch block) or
• 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
• 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.
• Intended emergent PCI to treat the STEMI
• 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

You may not qualify if:

• High suspicion for isolated right ventricular infarct confirmed with ECG lead V4R
• Cardiogenic shock with either of the following:
• 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
• Isolated narrow complex supraventricular tachycardia with ventricular response \>170 bpm or ventricular tachyarrhythmia with ventricular response \>150 bpm
• 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
• 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)
• 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.
• IABP, Impella or other mechanical circulatory support already in place for present indication (pre-randomization)
• Known end-stage renal disease, receiving dialysis
• 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
• Acute or chronic aortic dissection, if known
• Large or mobile LV thrombus, if known
• Prior PCI for the present infarction
• Prior PCI or coronary artery bypass graft (CABG) within 1 year, if known

Sponsors & Collaborators

• Abiomed Inc.: lead

Study Sites (7)

New Mexico Heart Institute

Albuquerque, New Mexico, 87102, United States

Location

Rigshospitalet Copenhagen

Copenhagen, Denmark

Location

Herzzentrum Dresden

Dresden, Saxony, 01307, Germany

Location

University Hospital Düsseldorf

Düsseldorf, Germany

Location

Universitatsklinikum Schleswig Holstein

Kiel, Germany

Location

Krankenhaus der Barmherzigen Brüder Trier

Trier, Germany

Location

Inselspital Bern

Bern, Switzerland

Location

Related Publications (1)

• Jentzer JC, Hibbert B. Optimal patient and mechanical circulatory support device selection in acute myocardial infarction cardiogenic shock. Lancet. 2024 Sep 14;404(10457):992-993. doi: 10.1016/S0140-6736(24)01588-5. Epub 2024 Sep 2. No abstract available.

  PMID: 39236724 DERIVED

MeSH Terms

Conditions

ST Elevation Myocardial Infarction; Shock, Cardiogenic; Cardiovascular Diseases; Myocardial Infarction; Heart Failure

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Shock

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Navin Kapur, MD

  Tufts Medical Center

  PRINCIPAL INVESTIGATOR

• William O'Neill, MD

  Henry Ford Health System

  PRINCIPAL INVESTIGATOR

• Gregg Stone, MD

  Icahn School of Medicine at Mount Sinai

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective, multicenter, randomized, controlled, open-label two-arm trial with an adaptive design

Study Record Dates

• First Submitted: August 15, 2022
• First Posted: August 18, 2022
• Study Start: October 28, 2023
• Primary Completion: May 10, 2024
• Study Completion: December 6, 2024
• Last Updated: January 29, 2025

Record last verified: 2025-01

Locations

CH (1); DK (1); DE (4); US (1)