What side effects are associated with this type of intervention?

Common treatments for Left Ventricular Dysfunction (LVD) include pharmacologic therapies such as mineralocorticoid receptor antagonists, sodium-glucose co-transporter 2 inhibitors, and mechanical circulatory support devices like the Impella 5.5. Known side effects of these treatments can vary. Mineralocorticoid receptor antagonists may cause hyperkalemia and renal dysfunction. Sodium-glucose co-transporter 2 inhibitors can lead to urinary tract infections and dehydration. Mechanical circulatory support devices, such as the Impella 5.5, may result in complications like bleeding, infection, and vascular injury. It is essential to monitor patients closely for these potential side effects to manage them effectively.

What prior FDA approvals exist?

The FDA has approved several treatments for Left Ventricular Dysfunction, particularly focusing on mechanical circulatory support devices and pharmacological therapies. Mechanical circulatory support devices like the Impella 5.5, which assists the heart in pumping blood, have been approved to provide temporary support for patients with severe heart failure. Other similar devices include the intra-aortic balloon pump (IABP) and ventricular assist devices (VADs) such as the HeartMate II and HeartWare HVAD. Pharmacological treatments include beta-blockers (e.g., metoprolol, carvedilol), ACE inhibitors (e.g., enalapril), angiotensin II receptor blockers (e.g., losartan), and aldosterone antagonists (e.g., spironolactone), which have been shown to improve outcomes in patients with heart failure and reduced ejection fraction.

What other types of research exist?

Promising alternatives to the Impella 5.5 for left ventricular dysfunction patients include the HeartMate 3 Left Ventricular Assist Device (LVAD), which offers improved hemocompatibility and reduced risk of thrombosis, and the use of advanced biventricular pacemakers for cardiac resynchronization therapy (CRT) to improve heart function. Additionally, novel gene therapies and regenerative medicine approaches, such as stem cell therapy, are being explored for their potential to repair and regenerate damaged heart tissue.

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Mechanical Circulatory Support Device

Impella Device for Heart Failure (IMPACT Trial)

N/A

Waitlist Available

Research Sponsored by Abiomed Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 18 years or older

Patients undergoing elective or urgent cardiac surgery procedures on CPB including aortic cross-clamping and cardioplegic arrest

Must not have

Various cardiac conditions including VSD, restrictive or obstructive cardiomyopathy, pericardial conditions, and prior mantle field chest irradiation

History of chronic dialysis, pre-existing liver dysfunction, pre-existing pulmonary disease requiring home oxygen, systemic active infection, confirmed COVID-19 infection within two weeks prior to operation, suspected or known pregnancy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 90 days post-op

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects of using the Impella 5.5 may include bleeding due to heparin use (a blood thinner required for its placement), risk of infection at insertion site, possible damage to blood cells or vessels from the device, and complications related to heart devices.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I do not have chronic kidney issues, liver problems, need for home oxygen, active infections, recent COVID-19, or pregnancy.

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I had a severe heart condition during my first surgery.

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I was unresponsive within a day after my surgery.

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I need or might need mechanical support for my heart's right ventricle before or after surgery.

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I need a procedure that stops my blood circulation.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 90 days post-op

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~90 days post-op

This trial's timeline: 3 weeks for screening, Varies for treatment, and 90 days post-op for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Acute Kidney Injury

Dosages for inotropic/vasopressor (Hours)

Major Bleeding

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Impella ArmExperimental Treatment1 Intervention

Impella 5.5 with SmartAssist

0 / 8Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Left Ventricular Dysfunction (LVD) include pharmacologic agents like beta-blockers, ACE inhibitors, and mineralocorticoid receptor antagonists, which reduce the heart's workload, lower blood pressure, and prevent fluid retention. Mechanical treatments, such as the Impella 5.5 device, provide direct circulatory support by assisting the heart in pumping blood. This improves hemodynamics and end-organ perfusion, which is crucial for LVD patients to maintain adequate cardiac output and prevent further deterioration of heart function.

Current indication and practical management of percutaneous left ventricular assist device support therapy in Japan.Surgical therapy for dilated cardiomyopathy.