Impella Device for Heart Failure

(IMPACT Trial)

Recruiting at 28 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

100 Participants Needed

Trial Summary

What is the purpose of this trial?

This Trial is testing a small heart pump called Impella 5.5 in patients undergoing high-risk heart surgery. These patients have very weak hearts, making surgery particularly dangerous for them. The Impella 5.5 helps their hearts pump blood, aiming to improve their recovery and overall outcomes. The Impella device has been increasingly used in various clinical scenarios, including high-risk coronary interventions and acute myocardial infarction.

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 data supports the effectiveness of the Impella 5.5 with SmartAssist treatment for heart failure?

Research shows that mechanical devices like left ventricular assist devices (LVADs) can improve survival and quality of life in patients with advanced heart failure. These devices help the heart pump blood more effectively, which can lead to better outcomes for patients who are not eligible for heart transplants. ^{1 2 3 4 5}

Is the Impella device generally safe for use in humans?

The Impella device, including the Impella 5.5 with SmartAssist, has been associated with serious complications such as bleeding, issues with device placement or removal, and vascular problems. There is also a high rate of in-hospital mortality reported in patients using the device, highlighting the need for more research to confirm its safety. ^{6 7 8 9 10}

How is the Impella 5.5 with SmartAssist treatment different from other heart failure treatments?

The Impella 5.5 with SmartAssist is unique because it is a temporary left ventricular assist device (a pump that helps the heart circulate blood) that can provide full circulatory support for up to 14 days, offering a minimally invasive option for patients with severe heart failure who need short-term support. ^{6 9 10 11 12}

Eligibility Criteria

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 18 years old or older.

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

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

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

Treatment Details

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.

Participant Groups

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

Findings from Research

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Management strategies for stage-D patients with acute heart failure. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Therapies for Advanced Heart Failure Patients Ineligible for Heart Transplantation: Beyond Pharmacotherapy. [2020]

3. England pubmed.ncbi.nlm.nih.gov

Characteristics and outcome of ambulatory heart failure patients receiving a left ventricular assist device. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Newer mechanical devices in the management of acute heart failure. [2022]

5. United States 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). [2018]

6. United States pubmed.ncbi.nlm.nih.gov

Early Outcomes of the First 200 US Patients Treated with Impella 5.5: A Novel Temporary Left Ventricular Assist Device. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Percutaneous retrograde left ventricular assist support for interventions in patients with aortic stenosis and left ventricular dysfunction. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Analysis of Adverse Events Related to Impella Usage (from the Manufacturer and User Facility Device Experience and National Inpatient Sample Databases). [2022]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Impella 5.5 Direct Aortic Implant and Explant Techniques. [2021]

10. Germany pubmed.ncbi.nlm.nih.gov

A case of left ventricular free wall rupture after insertion of an IMPELLA® left ventricular assist device diagnosed by transesophageal echocardiography. [2021]

11. United States pubmed.ncbi.nlm.nih.gov

Use of a percutaneous temporary circulatory support device as a bridge to decision during acute decompensation of advanced heart failure. [2019]

12. Germany pubmed.ncbi.nlm.nih.gov

Pitfalls of anesthetic management with the Impella® 5.0 device: a case series. [2020]