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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up every 4 hours for first 72 hours post-op and then every 12 hours until removal of pulmonary artery catheter until icu discharge
Awards & highlights
IMPACT Trial Summary
This trial tests the safety and effectiveness of a device that helps with heart surgery and how it may improve outcomes for those with weakened hearts.
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.Check my eligibility
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.See study design
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.
IMPACT Trial 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.
IMPACT Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ every 4 hours for first 72 hours post-op and then every 12 hours until removal of pulmonary artery catheter until icu discharge
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~every 4 hours for first 72 hours post-op and then every 12 hours until removal of pulmonary artery catheter until icu discharge
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Composite of All-Cause Mortality
New requirement for Renal Replacement Therapy (RRT)
Stroke (as defined by STS)
Secondary outcome measures
Acute Kidney Injury
Dosages for inotropic/vasopressor (Hours)
Duration of mechanical support (hours)
+10 moreIMPACT Trial Design
1Treatment groups
Experimental Treatment
Group I: Impella ArmExperimental Treatment1 Intervention
Impella 5.5 with SmartAssist
Find a Location
Who is running the clinical trial?
Abiomed Inc.Lead Sponsor
41 Previous Clinical Trials
34,455 Total Patients Enrolled
2 Trials studying Left Ventricular Dysfunction
1,375 Patients Enrolled for Left Ventricular Dysfunction
Media Library
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is it possible for individuals to join this medical experiment at present?
"Clinicaltrials.gov reports that this particular study, which was initially posted on April 15th 2023 , is no longer actively recruiting individuals for the trial. However, there are currently 35 other medical trials seeking participants at present."
Answered by AI
What is the geographic scope of this research initiative in North America?
"This research endeavour is being conducted at 8 sites, with Boston, Hackensack and Plano among them. To reduce travelling expectations for participants, it is important to choose the clinic that is most convenient geographically."
Answered by AI
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