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Mechanical Circulatory Support Device

Impella ECP Device for Heart Procedure Support

N/A
Waitlist Available
Led By Amir Kaki, 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 below
Select...
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 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

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 more

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
41 Previous Clinical Trials
33,999 Total Patients Enrolled
Seth Bilazarian, MDStudy DirectorAbiomed Inc.
1 Previous Clinical Trials
100 Total Patients Enrolled
Chuck Simonton, MDStudy DirectorAbiomed Inc.
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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this medical experiment accept participants aged 65 and over?

"This research is currently accepting participants above the age of legal consent and below 90 years old."

Answered by AI

Is there an ongoing recruitment process for this medical trial?

"According to the data hosted on clinicaltrials.gov, this trial is presently recruiting participants. It was first posted on December 20th 2022 and has since been revised as recently as December 23rd of that same year."

Answered by AI

How many participants have been enlisted for this medical research?

"Affirmative. Clinicaltrials.gov asserts that this research project, which was created on December 20th 2022, is actively looking for participants. About 256 people have to be recruited from 1 clinical site."

Answered by AI

May I sign up to join this research endeavor?

"This medical trial is searching for 256 individuals aged between 18 and 90 years old who have already undergone a percutaneous coronary intervention. The patients must be in a stable condition, with the assessment of their heart made by an expert team involving cardiac surgeons that determine this to be the best therapeutic option available. Additionally, all candidates need to provide written informed consent prior to joining the research project."

Answered by AI
~159 spots leftby Sep 2024