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Mechanical Circulatory Support Device
Impella ECP Device for Heart Procedure Support
N/A
Waitlist Available
Led By Duane Pinto, MD
Research Sponsored by Abiomed Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Subject is hemodynamically stable and a heart team, including a cardiac surgeon, has determined that an elective or urgent (not emergent) high-risk PCI is the appropriate therapeutic option
Age ≥18 years and ≤90 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up device delivery through 30 days
Awards & highlights
Study Summary
This trialassesses how safe Impella ECP device is for adults needing heart procedure to prevent heart and stroke complications.
Who is the study for?
Adults aged 18-90 who need high-risk heart procedures (not emergency ones) and are stable enough for it. They must understand the study and agree to participate. People with kidney failure on dialysis, severe valve disease, blood clots in the heart, certain vessel diseases, recent strokes or bleeding in the brain, severe heart failure, or part of vulnerable groups like those with mental disabilities can't join.Check my eligibility
What is being tested?
The trial is testing a device called Impella ECP during high-risk procedures to open blocked arteries in the heart. It's looking at how well it prevents major problems like heart attacks or strokes after treatment. Everyone gets the same device; there's no comparison group.See study design
What are the potential side effects?
Possible side effects include issues related to placing the device such as bleeding at the site where it enters your body, damage to blood vessels, blood clots that could lead to stroke or other complications from having a foreign object inside your body.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My heart condition is stable, and a team of heart specialists has recommended a specific heart procedure.
Select...
I am between 18 and 90 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ device delivery through 30 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~device delivery through 30 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Hemorrhage
Impella ECP-related major vascular complications (Safety Endpoint 1)
Rate of MACCE
Secondary outcome measures
Length of Hospital Stay for enrolled patients
Number of Subjects with Aortic Valve Injury
Number of Subjects with Escalation of Care to Impella CP
+1 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Impella ECP DeviceExperimental Treatment1 Intervention
Subjects receiving the Impella ECP.
Find a Location
Who is running the clinical trial?
Abiomed Inc.Lead Sponsor
41 Previous Clinical Trials
33,999 Total Patients Enrolled
Duane Pinto, MDPrincipal InvestigatorBeth Israel Deaconess Medical Center
1 Previous Clinical Trials
100 Total Patients Enrolled
Seth Bilazarian, MDStudy DirectorAbiomed Inc.
1 Previous Clinical Trials
100 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had surgery to replace or repair my aortic valve.I am currently experiencing severe heart failure or shock.I am allergic or react badly to heparin, contrast dyes, or aspirin.I have had a stroke or brain bleed, or have a condition that increases my risk of brain bleeding.My heart condition is stable, and a team of heart specialists has recommended a specific heart procedure.I do not have an infection or fever at the surgery site or in my body.I am currently receiving dialysis.I am between 18 and 90 years old.I had COVID-19 symptoms or was hospitalized but have been symptom-free for 8 weeks.My heart valve condition may prevent safe use of a specific heart pump.I have a low platelet count or a bleeding disorder and am not open to blood transfusions.I have a known disease of the aorta or an aortic dissection.I don't have conditions that prevent the use of an Impella device due to issues with my aorta or leg arteries.
Research Study Groups:
This trial has the following groups:- Group 1: Impella ECP Device
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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