Impella CP® for Heart Attack and Cardiogenic Shock
(RECOVER IV Trial)

Recruiting in Palo Alto (17 mi)

+14 other locations

William O'Neill, MD | Henry Ford Health ...

Overseen byWilliam O'Neill, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Abiomed Inc.

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial is testing whether using an Impella device to help the heart pump blood before opening blocked arteries improves survival in patients with severe heart attacks and heart failure. The Impella device temporarily assists the heart, allowing it to rest while maintaining blood flow. The goal is to see if this approach reduces deaths compared to other treatments. The Impella device has been shown to improve blood flow in the heart and is used as a last-resort treatment in patients with severe heart conditions.

Research Team

Navin Kapur, MD

Principal Investigator

Tufts Medical Center

William O'Neill, MD

Principal Investigator

Henry Ford Health System

Gregg Stone, MD

Principal Investigator

Icahn School of Medicine at Mount Sinai

Eligibility Criteria

The RECOVER IV Trial is for patients who've had a severe type of heart attack (STEMI) leading to cardiogenic shock within the last 12 hours. They must be planning to undergo an emergency procedure to open blocked arteries (PCI), have low blood pressure despite treatment, and show signs of poor blood flow to organs. Excluded are those with certain medical conditions like prior strokes, severe infections, or life expectancy less than a year.

Inclusion Criteria

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

I have specific heart attack signs on an EKG and a confirmed blockage in my heart's arteries.

I am scheduled for an emergency procedure to treat a severe heart attack.

See 1 more

Exclusion Criteria

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

You are already using certain devices to help your heart function.

You are part of a group that may have difficulty making decisions for themselves, like people with disabilities or those living in nursing homes or homeless shelters.

See 24 more

Treatment Details

Interventions

Impella CP® (Mechanical Circulatory Support Device)

Trial OverviewThis trial tests if starting Impella CP® support before opening blocked arteries in the heart improves survival and recovery compared to standard treatments without Impella. Patients with STEMI-cardiogenic shock will either receive this device-based strategy or continue with usual care methods before their PCI procedure.

Participant Groups

2Treatment groups

Experimental Treatment

Active Control

Group I: Treatment ArmExperimental Treatment1 Intervention

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

Group II: Control ArmActive Control1 Intervention

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.