RECOVER IV Trial Discontinued

RECOVER IV Trial Discontinued

The RECOVER IV Trial was a clinical study designed to evaluate the use of an FDA-approved temporary heart pump, called Impella CP, to treat patients with major heart attacks causing reduced heart function (heart shock). The goal of the study was to learn whether using this pump helps patients recover better after their heart shock (also called cardiogenic shock).

Three U.S. hospitals were involved in this study:

  • New Mexico Heart Institute, Albuquerque, NM
  • Presbyterian Hospital, Albuquerque, NM
  • Allegheny General Hospital, Pittsburgh, PA

The study was to be conducted during emergency medical situations and many eligible patients were expected to be too sick to make healthcare decisions or give their consent to participate in the study. For this reason, doctors at these hospitals engaged with community members before the study started to notify the community of RECOVER IV Trial and to obtain community-based feedback.

New Mexico Heart Institute (NMHI) is the only hospital in the United States that started enrolling patients in the study. One patient was enrolled at NMHI. Three hospitals from outside the U.S. also participated in this study and enrolled three patients.

Presbyterian Hospital and Allegheny General Hospital were getting ready to start the study. In preparation for the study start, they engaged community members but did not enroll any participants.

On June 4, 2024, the RECOVER IV Trial was discontinued by the sponsor, Abiomed Inc, based on the recommendation from an independent expert committee that monitored the safety of patients in the study, called data and safety monitoring board (DSMB). The recommendation was made because of the positive results of a separate study, called DanGer Shock. This study demonstrated that routine use of Impella CP improved survival in patients with heart attack- related shock. This means that the RECOVER IV Trial will no longer enroll patients at any participating site.

Please review the FAQ section below to learn more.

RECOVER IV Discontinuation FAQs

RECOVER IV is being discontinued because of the positive results of a randomized controlled trial (RCT) called the DanGer Shock RCT. The DanGer Shock results were published in April in the New England Journal of Medicine and demonstrate routine use of Impella CP improves survival in STEMI-related cardiogenic shock.

The trial was discontinued by Abiomed following the recommendation from the independent Data and Safety Monitoring Board (DSMB), which found that equipoise for randomization no longer exists. The Trial National Principal Investigators (PIs), Study Chair and the FDA are aligned with this decision.

Equipoise is when there is uncertainty about the benefits of one treatment versus another. When equipoise for randomization no longer exists, then there is belief that one treatment is more beneficial than the other, and it would be unethical for patients to get the inferior treatment.

Randomized controlled trials (RCTs) are monitored by an independent group of experts called a data and safety monitoring board (DSMB). These experts review study information as it comes in and are responsible for ensuring that an RCT is safe and ethical for study participants.

Patients will be notified of study discontinuation and will be followed for one (1)-year, as originally planned in the study protocol.