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The RECOVER IV Trial

NCT05506449 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2025-01-29

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Abiomed Inc.

    lead INDUSTRY

Principal Investigators

  • Navin Kapur, MD · Tufts Medical Center

  • William O'Neill, MD · Henry Ford Health System

  • Gregg Stone, MD · Icahn School of Medicine at Mount Sinai

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-28
Primary Completion
2024-05-10
Completion
2024-12-06
FDA Device
Yes

Countries

  • United States
  • Denmark
  • Germany
  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05506449 on ClinicalTrials.gov