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The RECOVER IV Trial (RECOVER IV)

Primary Purpose

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

Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Impella CP®
Standard of Care
Sponsored by
Abiomed Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for ST-segment Elevation Myocardial Infarction (STEMI) focused on measuring Cardiovascular Diseases, Myocardial Infarction, Heart Failure, Exception From Informed Consent (EFIC), Cardiogenic Shock

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Tufts Medical Center
  • Henry Ford Health System
  • Hackensack University Medical Center
  • New Mexico Heart InstituteRecruiting
  • Presbyterian Healthcare Services
  • Allegheny General Hospital
  • UPMC Presbyterian
  • Herzzentrum Dresden

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control Arm

Treatment Arm

Arm Description

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.

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

Outcomes

Primary Outcome Measures

All-Cause Mortality

Secondary Outcome Measures

Major Adverse Cardiovascular and Cerebrovascular Events (MACCE)
Days Alive Out-of-Hospital
Mean Change in Health-Related Quality of Life, as measured by Kansas City Cardiomyopathy Questionnaire

Full Information

First Posted
August 15, 2022
Last Updated
October 12, 2023
Sponsor
Abiomed Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05506449
Brief Title
The RECOVER IV Trial
Acronym
RECOVER IV
Official Title
Early Impella® Support in Patients With ST-Segment Elevation Myocardial Infarction Complicated by Cardiogenic Shock: The RECOVER IV Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 12, 2023 (Anticipated)
Primary Completion Date
April 30, 2026 (Anticipated)
Study Completion Date
December 30, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abiomed Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ST-segment Elevation Myocardial Infarction (STEMI), Cardiogenic Shock
Keywords
Cardiovascular Diseases, Myocardial Infarction, Heart Failure, Exception From Informed Consent (EFIC), Cardiogenic Shock

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective, multicenter, randomized, controlled, open-label two-arm trial with an adaptive design
Masking
None (Open Label)
Allocation
Randomized
Enrollment
560 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control Arm
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Treatment Arm
Arm Type
Experimental
Arm Description
Subjects randomized to the Treatment Arm will receive hemodynamic support using an Impella-based treatment strategy initiated prior to percutaneous coronary intervention (PCI).
Intervention Type
Device
Intervention Name(s)
Impella CP®
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Standard of Care
Intervention Description
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.
Primary Outcome Measure Information:
Title
All-Cause Mortality
Time Frame
30 Days
Secondary Outcome Measure Information:
Title
Major Adverse Cardiovascular and Cerebrovascular Events (MACCE)
Time Frame
30 Days
Title
Days Alive Out-of-Hospital
Time Frame
6 Months
Title
Mean Change in Health-Related Quality of Life, as measured by Kansas City Cardiomyopathy Questionnaire
Time Frame
1 Year
Other Pre-specified Outcome Measures:
Title
All-Cause Mortality
Time Frame
At hemodynamic stability and when the subject is no longer hospitalized, 6 Months, 1 Year
Title
MACCE
Time Frame
At hemodynamic stability when the subject is no longer hospitalized, 6 Months, 1 Year
Title
Days Alive Out-of-Hospital
Time Frame
30 Days, 6 Months
Title
Mean Change in Health-Related Quality of Life, as measured by Kansas City Cardiomyopathy Questionnaire
Time Frame
30 Days Post-Discharge, 6 Months
Title
Mean Change in Health-Related Quality of Life, as measured by Rose Dyspnea Score
Time Frame
30 Days Post-Discharge, 6 Months, 1 Year
Title
Mean Change in Health-Related Quality of Life, as measured by EQ-5D-5L
Time Frame
30 Days Post-Discharge, 6 Months, 1 Year
Title
Left Ventricular Ejection Fraction (LVEF)
Time Frame
30 Days, 6 Months
Title
Estimated Glomerular Filtration Rate (eGFR)
Time Frame
At hemodynamic stability when the subject is no longer hospitalized, 30 Days, 6 Months, 1 Year
Title
Number of Participants with need for In-Hospital Hemodialysis or Continuous Renal Replacement Therapy (CRRT)
Time Frame
At hemodynamic stability when the subject is no longer hospitalized
Title
Number of Participants with need for Dialysis Post-Index Hospitalization
Time Frame
30 Days, 6 Months, 1 Year
Title
Number of Participants with any Dialysis
Time Frame
30 Days, 6 Months, 1 Year
Title
All-Cause Hospitalizations
Time Frame
30 Days, 6 Months, 1 Year
Title
Cardiovascular Hospitalizations
Time Frame
30 Days, 6 Months, 1 Year
Title
Heart Failure Hospitalizations
Time Frame
30 Days, 6 Months, 1 Year
Title
Number of Participants with new Implantable Cardioverter Defibrillator (ICD) or Cardiac Resynchronization Therapy (CRT) Implant
Time Frame
At hemodynamic stability when the subject is no longer hospitalized, 30 Days, 6 Months, 1 Year
Title
Number of Participants with Left Ventricular Assist Device (LVAD) or Heart Transplant (including United Network for Organ Sharing (UNOS) 1/2 listing)
Time Frame
At hemodynamic stability when the subject is no longer hospitalized, 30 Days, 6 Months, 1 Year
Title
Repeat Target Vessel Revascularization (TVR)
Time Frame
30 Days, 6 Months, 1 Year
Title
Acute Kidney Injury (AKI)
Time Frame
within 7 Days Post-Percutaneous Coronary Intervention (PCI)
Title
Disability Assessed using the Modified Rankin Scale
Time Frame
At hemodynamic stability when the subject is no longer hospitalized, 30 Days, 6 Months, 1 Year
Title
30-day survival with mRS score ≤3
Time Frame
30 day
Title
Number of Participants with Neurologic Academic Research Consortium (NeuroARC) Type 1 Stroke
Time Frame
At hemodynamic stability when the subject is no longer hospitalized
Title
Major Bleeding
Time Frame
Shock Academic Research Consortium (SHARC) Types 3-5, At hemodynamic stability when the subject is no longer hospitalized
Title
Major Vascular Complications
Time Frame
SHARC Definition, At hemodynamic stability when the subject is no longer hospitalized
Title
Major Hemolysis
Time Frame
At hemodynamic stability when the subject is no longer hospitalized
Title
Major Cath Lab Complications
Description
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).
Time Frame
All adverse events will be recorded and documented through 1 year follow up or study completion
Title
All Stroke
Time Frame
At hemodynamic stability when the subject is no longer hospitalized
Title
Minor Bleeding
Time Frame
At hemodynamic stability when the subject is no longer hospitalized
Title
Minor Vascular Complications
Time Frame
At hemodynamic stability when the subject is no longer hospitalized
Title
Minor Hemolysis
Time Frame
At hemodynamic stability when the subject is no longer hospitalized

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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 Ongoing cardiopulmonary resuscitation (CPR) 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: They did not have a cardiac arrest and were following verbal commands prior to intubation or They are clearly following verbal commands after intubation Prior stroke with permanent, significant neurological defect Prior intracranial hemorrhage or known intracerebral mass, aneurysm or fistula Acute or suspected stroke prior to randomization Active infection requiring oral or intravenous antibiotics Prior heparin-induced thrombocytopenia, if known Other severe, concomitant disease with limited life expectancy <1 year (other than cardiogenic shock) Pregnancy, known or suspected 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 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 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) 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] Patient is wearing a bracelet or other item indicating their wishes to decline participation in the study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sameera Dasari, PhD
Phone
978-914-8882
Email
sdasari@abiomed.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Navin Kapur, MD
Organizational Affiliation
Tufts Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
William O'Neill, MD
Organizational Affiliation
Henry Ford Health System
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gregg Stone, MD
Organizational Affiliation
Icahn School of Medicine at Mount Sinai
Official's Role
Study Chair
Facility Information:
Facility Name
Tufts Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Haval Chweich, MD
Facility Name
Henry Ford Health System
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mir B Basir, DO
Facility Name
Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Haroon Faraz
Facility Name
New Mexico Heart Institute
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87102
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mark Bieniarz
Facility Name
Presbyterian Healthcare Services
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87106
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robert Federici, MD
Facility Name
Allegheny General Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Lasorda
Facility Name
UPMC Presbyterian
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeffrey Fowler
Facility Name
Herzzentrum Dresden
City
Dresden
State/Province
Saxony
ZIP/Postal Code
01307
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Norman Mangner

12. IPD Sharing Statement

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The RECOVER IV Trial

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