FAQs

We are studying the Impella CP heart pump to see if it improves the heart's ability to recover when combined with other standard treatments.

All patients will receive standard care if they join this study. If they receive the Impella CP, the device may help the pumping function of their sick heart, reduce the need for medications during care, reduce problems, and improve survival and quality of life. There is no guarantee that this will happen. The information gathered in this study will add to our understanding of treatment options for patients with heart attacks and shock.

We will enroll eligible adults between the ages of 18 – 90 who are treated at participating hospitals with heart attack and shock.

For more details on all inclusion and exclusion criteria, you can go to clinicaltrials.gov.

Patients who present at a participating hospital with a heart attack will be screened to check whether they are eligible to be enrolled in the study. If they are, they or their legally authorized representative or family member will be asked to provide written consent. If they do so, their eligibility will be quickly confirmed and then they will be enrolled in the study. Attempts will be made to have a face-to-face conversation with the patient or their legal representative. If the patient or their legal representative is unable to provide informed consent, then they will be given an opportunity to object to enrollment. If they do not object, they will be enrolled. Under the emergency research provision "exception from informed consent".

If no one can engage in a face-to-face conversation about the study, the patient's eligibility will be quickly confirmed and then the patient will be enrolled in the study. Patients who are enrolled under "exception from informed consent for emergency research" will be notified of their enrollment as soon as feasible and will be asked to give consent to continue in the study. for ongoing participation.

Patients in this study will require emergency treatment for their heart attack with heart shock in the hospital. The window of time (called the therapeutic window) needed to perform treatment for a heart attack is short. To get the best result, treatment for heart shock should start within 60 minutes of the patient's first medical contact. This usually means they need to go to the catheterization lab for a procedure within about 30 minutes of arrival in the Emergency Department. Since RECOVER IV affects initial treatment for heart shock, enrollment in this study must happen in the same time frame.

Enrollment: When an eligible patient joins this study, they will be randomly assigned to receive standard care treatment including medications and PCI with or without the Impella CP. Half of all study patients will receive the Impella CP. The other half will not. If they get the Impella CP, it will be inserted into their leg artery through a thin tube (catheter) and advanced through their blood vessel into the main pumping chamber of their heart. It then helps move blood from this chamber to the rest of the body. It will stay in place for at least 24 hours and will be removed when their doctor thinks it is appropriate to do so. If an eligible patient does not receive the Impella CP, doctors will treat them with other standard treatments. Doctors may use other devices if they think they are needed.

During hospitalization: Patients enrolled in the study will have their health monitored, and data will be reviewed and collected from their medical records for the study. The study team will obtain information throughout the patient's time in the hospital. This includes for example, results of blood tests, images, vital signs, health history, symptoms, and medication.

The study team will contact participants by phone 30 days after they have been discharged from the hospital to ask about how their heart attack impacted their life. Participants will also return to the hospital clinic 30 days, 6 months, and 12 months after their initial PCI procedure. When possible, these visits will happen at the same time as a patient's routine care follow-up visit. Follow up visit procedures include a physical exam, review of medications and side effects, blood draw for lab tests, and having pictures taken of the heart (an echocardiogram). Participants will be asked questions about how their heart attack has impacted their life.

Participants will be monitored for one (1) year following enrollment.

You can share information on this website with others in your community. You can also download a printed version of this brochure to share.

This study will be done in 50 sites throughout North America and Europe. For a list of study sites, you can view the Study Map.

The medical device being studied is a temporary heart pump called the Impella CP®. It has been approved by the US Food and Drug Administration (FDA) for use in patients with heart shock.

Multiple studies including the largest prospective observational study, National Cardiogenic Shock Initiative (NCSI) in the US show that use of Impella is associated with improved heart function and survival at 30 days. But we do not know whether the Impella CP® device is responsible for this improvement. Therefore, a randomized trial is needed to help us understand how to treat these patients.

There are known potential side effects of the Impella CP® including, but not limited to death, bleeding, stroke, infection, heart rhythm problems, damage to blood cells or heart tissues, liver failure and kidney failure. A risk specific to this study is damage to the heart due to delaying PCI while the Impella CP® is being placed.

Patients in this study will require emergency treatment for their heart attack in the hospital. A heart attack occurs unexpectedly. Since we cannot predict when a heart attack is going to occur, a person cannot sign up ahead of time for this research. Due to the severity of the medical condition, most patients will be too sick to make decisions about their healthcare during the therapeutic window. Emergency treatment cannot be delayed past this window of time, and it is not possible to wait to obtain consent for the study. If the patient is unable to provide informed consent and a legally authorized representative or family member is not immediately available or is unable to provide consent within the therapeutic window, the patient will be enrolled under an "exception from informed consent".

A special set of research rules allow emergency medicine studies to include patients with an "exception from informed consent" under these carefully controlled circumstances. This research is allowed to advance emergency care medicine if ALL of the following apply:

• The patient's life is at risk
• The best strategy is unknown
• The patient might benefit from the study, AND
• It is not possible to obtain consent from the patients' family or representatives before the study procedures need to begin.

Also, the study has been approved by the US Food and Drug Administration, a central Institutional Review Board, and an independent group of experts. Each of which will monitor the study.

If a patient is unable to provide written consent and a legally authorized representative is immediately available, we will ask their permission. If not available, we will give any immediately available family member an opportunity to object to enrollment. In addition, there may be signs that a patient does not wish to participate in a study. For example, a family member may communicate the patient's unwillingness to be in research. Or a patient may be wearing a bracelet that conveys their refusal to participate in research studies. If we learn of any objection to participation in research before the treatment begins, the patient will not be included in the study and will receive routine care outside of the study.

The research team will make several attempts to obtain informed consent form the patient's legally authorized representative or directly from the patient. If a patient has been enrolled in the study via an "exception from informed consent," researchers will, as soon as possible, inform the patient, their legal representative, or their family member of the patient's enrollment in the study. They will then be asked if they want to continue with the study.

The patient and the patient's legally authorized representative will have the opportunity to withdraw the patient from further study participation and will be provided instructions for how to do so.

This study is being sponsored and funded by Abiomed, Inc. of Danvers, Massachusetts.

Other treatments for heart shock include intravenous drugs that are intended to help maintain blood pressure and make the heart pump harder. There are also other pumps and devices that are sometimes used in patients with heart shock. These include balloon pumps and devices that help the body get enough oxygen (extracorporeal membrane oxygenation; ECMO). Neither drugs nor other pumps and devices have been shown to improve survival. All of them can be used for patients in the RECOVER IV trial if doctors think the patient would benefit from them.

Yes. People who do not want to be enrolled in the RECOVER IV Study can choose to opt out ahead of time by contacting the research team. To opt out, a person will need to wear a silicone engraved wristband for the duration of the 5-year study period. The wristband is engraved with "No RECOVER IV Study."

You can request an opt-out wristband by contacting the RECOVER IV Emergency Research Team at 1-888-249-6558 or opting out here.

You can share information on this website with others in your community. You can also download a printed version of this brochure to share.