Impella 5.5 for Heart Failure

(INTeGRATE Trial)

Not yet recruiting at 4 trial locations

Overseen By Stacie Hallaway

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Abiomed Inc.

Must be taking: Heart failure GDMT

Must not be taking: Anticoagulants, Antiplatelets

Disqualifiers: Renal disease, Liver dysfunction, Stroke, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: Hospital stay

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the Impella 5.5 SmartAssist device for individuals with heart failure. The goal is to determine if this device can enhance medical treatment for those with reduced heart pumping ability and a sudden worsening of heart failure. It targets individuals who have experienced heart failure for less than five years, currently struggle to maintain blood pressure, and are not receiving optimal heart medications. This device may help realign their treatment during and after a hospital stay. As an unphased trial, it provides a unique opportunity for patients to contribute to innovative research that could improve future heart failure treatments.

Do I need to stop my current medications for the trial?

The trial information does not specify if you need to stop your current medications. It's best to discuss this with the trial team or your doctor.

What prior data suggests that the Impella 5.5 SmartAssist is safe for heart failure patients?

Studies have shown that the Impella 5.5 SmartAssist device is generally well-tolerated by patients with heart failure and cardiogenic shock. In one study, 84% of patients survived until the device could be safely removed. Another report noted good survival rates when the device served as temporary support before a heart transplant or heart pump implant. While the Impella 5.5 has shown promise in aiding heart function, discussing potential risks or side effects with a healthcare provider is important before considering joining a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Impella 5.5 SmartAssist is unique because it provides mechanical circulatory support for patients with heart failure, offering a less invasive alternative to traditional options like heart transplants or ventricular assist devices (VADs). Unlike other treatments that require major surgery, the Impella 5.5 can be inserted percutaneously, meaning it is placed through a small incision, reducing recovery time and surgical risks. Researchers are excited about its advanced monitoring capabilities, which allow for real-time feedback on cardiac performance, helping to optimize patient outcomes more effectively.

What evidence suggests that the Impella 5.5 SmartAssist is effective for heart failure?

Previous studies have shown promising results for the Impella 5.5 SmartAssist in patients with heart failure and severe heart problems. Research indicates that the device improves survival rates, with one study reporting that 84% of patients survived after its removal. Additionally, patients using the Impella 5.5 experienced good outcomes over 6 and 12 months, often using it as a step towards heart transplants or other long-term treatments. The device provides significant support to the heart, allowing doctors to optimize medical treatments during hospital stays and after discharge. These findings suggest that the Impella 5.5 effectively manages serious heart conditions. ^{1 2 3 4 6}

Who Is on the Research Team?

Adam DeVore, MD, MHS

Principal Investigator

Duke University

Are You a Good Fit for This Trial?

This trial is for heart failure patients with reduced ejection fraction who are in cardiogenic shock. They should have a history of heart failure for less than 5 years, low blood pressure or need drugs to maintain it, and not be fully treated with guideline-directed medications. Participants must consent to the study and can't be severely dehydrated.

Inclusion Criteria

I have signed the informed consent document.

I have had very low blood pressure or needed medicine to keep my blood pressure up.

I need support from a heart pump device.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive Impella 5.5 support and initiation of guideline directed medical therapy (GDMT) during hospital stay

Hospital stay

In-hospital treatment

Post-discharge Follow-up

Participants are monitored for GDMT optimization and heart recovery up to 90 days post-discharge

90 days

Long-term Follow-up

Participants are monitored for outcomes such as GDMT optimization, heart recovery, and adverse events up to one year post-discharge

1 year

What Are the Treatments Tested in This Trial?

Interventions

• Impella 5.5 SmartAssist

Trial Overview The trial tests if using Impella 5.5 SmartAssist helps manage severe heart failure during hospitalization and after discharge by supporting the heart's pumping function while optimizing standard medication treatment.

How Is the Trial Designed?

Group I: Single arm study Experimental Treatment 1 Intervention

This is a single arm study.

Who Is Running the Clinical Trial?

Abiomed Inc.

Lead Sponsor

Trials

47

Recruited

33,900+

Founded

1981

Headquarters

Danvers, United States

Known For

Heart Recovery Technologies

Top Products

Impella heart pumps, AbioCor, Breethe OXY-1 System

Johnson & Johnson

Industry Sponsor

Trials

116

Recruited

167,000+

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S1071916425001484

Outcomes of Surgically Implanted Impella Microaxial Flow ... Patients with HF-CS treated with Impella 5.5 had overall favorable in-hospital, 6-month and 12-month survival, both as a bridge to NHS as HRT.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10011692/

Single center experience and early outcomes of Impella 5.5 Our results suggest that Impella 5.5 provides favorable survival in the management of HF and CS, particularly used for a bridge to heart transplant or LVAD.

3. abiomed.com abiomed.com/en-us/about-us/news-and-media/press-releases/study-finds-84-survival-rate-patients-cardiogenic-shock-and-other-challenging-cardiac

Study Finds 84% Survival Rate in Patients in Cardiogenic ... experience of patients who received Abiomed's newest heart pump, Impella 5.5 with SmartAssist, finds 84% of the patients survived to explant ...

4. jhltonline.org jhltonline.org/article/S1053-2498(23)00032-3/fulltext

Improved clinical outcomes associated with the Impella 5.5 ... Patients receiving the Impella 5.5 had significantly higher survival through explant (ie, successfully weaned or bridged to heart replacement therapy)

5. journals.lww.com journals.lww.com/asaiojournal/fulltext/2020/07000/new_surgical_circulatory_support_system_outcomes.6.aspx

New Surgical Circulatory Support System Outcomes Fifty-five patients underwent an Impella 5.5 implant for cardiomyopathy (45%), AMICGS (29%), PCCS (13%), preop CABG (5%), OPCAB (4%), and other (4%). Thirty- ...

6. cardiothoracicsurgery.biomedcentral.com cardiothoracicsurgery.biomedcentral.com/articles/10.1186/s13019-022-01871-1

Single center first year experience and outcomes with Impella ... Survival rate for Impella 5.5® use greater than 14 days was 67%. Of those who survived, 50% had native heart recovery, 17% had durable device ...