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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
Must not have
Previous aortic valve replacement or reconstruction
Cardiogenic shock or acutely decompensated pre-existing chronic heart failure. Cardiogenic shock is defined as: systemic hypotension (systolic BP <90 mmHg or the need for inotropes/pressors to maintain a systolic BP >90 mmHg) plus one of the following: any requirement for pressors/inotropes prior to arrival at the catheterization laboratory, clinical evidence of end-organ hypoperfusion or use of IABP or any other circulatory support device
Timeline
Screening 3 weeks
Treatment Varies
Follow Up device delivery through 30 days
Awards & highlights
No Placebo-Only Group

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.
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.
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 below
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My heart condition is stable, and a team of heart specialists has recommended a specific heart procedure.
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I am between 18 and 90 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had surgery to replace or repair my aortic valve.
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I am currently experiencing severe heart failure or shock.
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I am allergic or react badly to heparin, contrast dyes, or aspirin.
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I have had a stroke or brain bleed, or have a condition that increases my risk of brain bleeding.
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I do not have an infection or fever at the surgery site or in my body.
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I am currently receiving dialysis.
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My heart valve condition may prevent safe use of a specific heart pump.
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I have a low platelet count or a bleeding disorder and am not open to blood transfusions.
Select...
I have a known disease of the aorta or an aortic dissection.
Select...
I don't have conditions that prevent the use of an Impella device due to issues with my aorta or leg arteries.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~device delivery through 30 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and device delivery through 30 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Hemorrhage
Impella ECP-related major vascular complications (Safety Endpoint 1)
Rate of MACCE

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 ECP DeviceExperimental Treatment1 Intervention
Subjects receiving the Impella ECP.

Find a Location

Who is running the clinical trial?

Abiomed Inc.Lead Sponsor
44 Previous Clinical Trials
33,052 Total Patients Enrolled
Duane Pinto, MDPrincipal InvestigatorBeth Israel Deaconess Medical Center
1 Previous Clinical Trials
100 Total Patients Enrolled
Chuck Simonton, MDStudy DirectorAbiomed Inc.
1 Previous Clinical Trials
100 Total Patients Enrolled
Seth Bilazarian, MDStudy DirectorAbiomed Inc.
1 Previous Clinical Trials
100 Total Patients Enrolled
Amir Kaki, MDPrincipal InvestigatorAscension St. John Hospital
1 Previous Clinical Trials
100 Total Patients Enrolled

Media Library

Impella ECP (Mechanical Circulatory Support Device) Clinical Trial Eligibility Overview. Trial Name: NCT05334784 — N/A
Percutaneous Coronary Intervention Research Study Groups: Impella ECP Device
Percutaneous Coronary Intervention Clinical Trial 2023: Impella ECP Highlights & Side Effects. Trial Name: NCT05334784 — N/A
Impella ECP (Mechanical Circulatory Support Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05334784 — N/A
~0 spots leftby Dec 2024
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