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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 belowSelect...
I am 18 years old or older.
Select...
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:Select...
I have a heart condition like VSD, cardiomyopathy, or issues with the pericardium, or I've had chest radiation.
Select...
I do not have chronic kidney issues, liver problems, need for home oxygen, active infections, recent COVID-19, or pregnancy.
Select...
I had a severe heart condition during my first surgery.
Select...
I was unresponsive within a day after my surgery.
Select...
I need or might need mechanical support for my heart's right ventricle before or after surgery.
Select...
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
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 moreAwards & 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
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.
Current indication and practical management of percutaneous left ventricular assist device support therapy in Japan.Surgical therapy for dilated cardiomyopathy.
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Who is running the clinical trial?
Abiomed Inc.Lead Sponsor
41 Previous Clinical Trials
32,778 Total Patients Enrolled
2 Trials studying Left Ventricular Dysfunction
1,375 Patients Enrolled for Left Ventricular Dysfunction
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am allowed to have certain heart procedures along with my main treatment.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.I am 18 years old or older.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.I do not have chronic kidney issues, liver problems, need for home oxygen, active infections, recent COVID-19, or pregnancy.I had a severe heart condition during my first surgery.I was unresponsive within a day after my surgery.I need or might need mechanical support for my heart's right ventricle before or after surgery.I need a procedure that stops my blood circulation.I had a corrective surgery less than 24 hours before my main surgery.
Research Study Groups:
This trial has the following groups:- Group 1: Impella Arm
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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