Impella Device for Heart Failure

(IMPACT Trial)

Not currently recruiting at 30 trial locations

Overseen By Andrea Schminke

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Abiomed Inc.

Must not be taking: Inotropes, MCS devices

Disqualifiers: Stroke, Transplantation, Dialysis, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the Impella 5.5 with SmartAssist, a heart pump device designed to support patients with severe heart issues during high-risk heart surgeries. The researchers aim to determine if this device can improve heart function and overall recovery post-surgery. Suitable candidates include those planning complex heart surgeries with very weak heart function (LVEF of ≤25% or ≤35% with serious mitral valve problems). Joining this trial could help improve care for future patients undergoing similar surgeries. As an unphased trial, this study offers a unique opportunity to contribute to medical advancements and potentially enhance surgical outcomes for others.

Will I have to stop taking my current medications?

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

What prior data suggests that this device is safe for heart failure patients?

Research has shown that the Impella 5.5 with SmartAssist device yields promising results for patients with severe heart problems. One study found that 84% of patients survived until the device was removed, indicating positive outcomes. However, reports of side effects exist. Over the years, issues like bleeding and stroke related to this device have increased, with 104 cases reported in 2023. This suggests that while the device can be effective, risks must be considered, and discussing potential side effects with a doctor is important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Impella 5.5 with SmartAssist is unique because it provides mechanical circulatory support for heart failure patients in a minimally invasive way. Unlike traditional treatments like medications and surgical interventions, the Impella device is inserted via a catheter and can actively assist the heart in pumping blood, offering immediate support. Researchers are excited about this treatment because it can stabilize patients quickly, potentially leading to faster recovery times and improved outcomes compared to conventional therapies.

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

Research shows that the Impella 5.5 with SmartAssist, which participants in this trial will receive, holds promise for patients with heart failure and cardiac shock. Studies have found that 84% of patients using this device survive, particularly those needing support until they can receive a heart transplant or a left ventricular assist device (LVAD). Patients using the Impella 5.5 have a better chance of surviving until the device can be safely removed or further treatment can be administered. These findings suggest that the Impella 5.5 may improve patient outcomes during high-risk heart surgery by enhancing the heart's ability to pump blood effectively. ^{1 2 5 6 7}

Who Is on the Research Team?

Edward Soltesz, MD

Principal Investigator

The Cleveland Clinic

Daniel Goldstein, MD

Principal Investigator

Montefiore Medical Center

Hermann Reichenspurner, MD, PhD

Principal Investigator

University Heart & Vascular Center Hamburg

Are You a Good Fit for This Trial?

The IMPACT trial is for adults over 18 with severe left ventricular dysfunction (LVEF ≤30% or ≤35% with significant mitral regurgitation) who need high-risk heart surgery. Candidates must not have chronic kidney disease, liver or severe lung issues, active infections including recent COVID-19, be pregnant, in another trial's active phase, or have conditions that could interfere with the study.

Inclusion Criteria

I am allowed to have certain heart procedures along with my main treatment.

I am scheduled for heart surgery that involves stopping my heart and using a heart-lung machine.

My heart's pumping ability is low, confirmed by a recent test.

Exclusion Criteria

Subject has other medical, social or psychological problems that compromises the subject's ability to give written informed consent and/or to comply with trial procedures

I have a heart condition like VSD, cardiomyopathy, or issues with the pericardium, or I've had chest radiation.

You cannot take heparin, have a history of bleeding disorders or blood clotting problems, or have limitations that would prevent the placement of Impella 5.5.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo cardiac surgery with the use of Impella 5.5 with SmartAssist peri-operatively

1 day

Intra-op

Post-operative Monitoring

Participants are monitored for early hemodynamics, end-organ function, and clinical outcomes

Up to 30 days

Hospital and ICU stay

Follow-up

Participants are monitored for safety and effectiveness after treatment

90 days

Post-op follow-up visits

What Are the Treatments Tested in This Trial?

Interventions

• Impella 5.5 with SmartAssist

Trial Overview This study tests the Impella 5.5 device during high-risk cardiac surgeries to see if it improves heart function and patient outcomes post-surgery. The Impella 5.5 aims to assist patients' hearts peri-operatively by maintaining blood flow and reducing strain on the heart.

How Is the Trial Designed?

Group I: Impella Arm Experimental Treatment 1 Intervention

Impella 5.5 with SmartAssist

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

Published Research Related to This Trial

In the ROADMAP study, patients with advanced heart failure who received a left ventricular assist device (LVAD) showed significant improvements in health-related quality of life (hrQoL) compared to those receiving optimal medical management, particularly in patients with low baseline quality of life scores (VAS < 55).

Patients with low baseline hrQoL (VAS < 55) had better survival rates on LVAD therapy (82%) compared to those on optimal medical management (58%), highlighting the importance of assessing hrQoL when considering LVAD implantation for heart failure patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-Reported Health-Related Quality of Life Is a Predictor of Outcomes in Ambulatory Heart Failure Patients Treated With Left Ventricular Assist Device Compared With Medical Management: Results From the ROADMAP Study (Risk Assessment and Comparative Effectiveness of Left Ventricular Assist Device and Medical Management). Stehlik, J., Estep, JD., Selzman, CH., et al.[2018]

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. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1071916423004177

Real-world Experience Of Adverse Events And Modes ... The temporal trends for annual reporting of the adverse events related to Impella 5.5 devices were 3 in 2019 followed by 29 in 2020, 67 in 2021, and 104 in 2023 ...

7. jhltonline.org jhltonline.org/article/S1053-2498(25)02035-2/fulltext

Clinical management of the Impella 5.5 pump Special emphasis is placed on complication management, including bleeding, hemolysis, right ventricular dysfunction, stroke, aortic valve injury ...