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Mechanical Circulatory Support Device

Impella ECP Device for High-Risk Heart Procedures (ECP EFS Trial)

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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through end of study, 30 days
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing how safe and effective the Impella ECP device is for people undergoing a high-risk heart procedure.

Who is the study for?
This trial is for adults aged 18-90 scheduled for a high-risk heart procedure (percutaneous coronary intervention) with hemodynamic support. Participants must consent and not have conditions like previous valve replacements, severe vessel disease, or recent COVID-19 symptoms. They can't join if they're on dialysis, pregnant, in shock, part of another study's active phase, belong to vulnerable populations or have bleeding disorders.
What is being tested?
The Impella ECP Early Feasibility Study is testing the safety of the Impella ECP device in patients undergoing elective high-risk heart procedures. It's a single-group study where all participants receive the same treatment to see how well it works and what risks are involved.
What are the potential side effects?
While specific side effects aren't listed here, similar devices may cause vascular complications at insertion sites, bleeding due to blood thinners used during the procedure, issues related to heart function and possible reactions to contrast media used.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through end of study, 30 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and through end of study, 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
Feasibility: successful hemodynamic support
Safety: Major Device-Related Adverse Events
Secondary study objectives
Procedural Success
Rate of composite Major Device-Related Adverse Events
Rate of each individual Major Device-Related Adverse Event
+1 more

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: Subjects receiving the Impella ECPExperimental Treatment1 Intervention

Find a Location

Who is running the clinical trial?

Abiomed Inc.Lead Sponsor
43 Previous Clinical Trials
33,478 Total Patients Enrolled
Amir Kaki, MDPrincipal InvestigatorAscension St. John Hospital
1 Previous Clinical Trials
556 Total Patients Enrolled
Shon Chakrabarti, MDStudy DirectorAbiomed Inc.

Media Library

Impella ECP (Mechanical Circulatory Support Device) Clinical Trial Eligibility Overview. Trial Name: NCT04477603 — N/A
Percutaneous Coronary Intervention Research Study Groups: Subjects receiving the Impella ECP
Percutaneous Coronary Intervention Clinical Trial 2023: Impella ECP Highlights & Side Effects. Trial Name: NCT04477603 — N/A
Impella ECP (Mechanical Circulatory Support Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04477603 — N/A
~18 spots leftby Oct 2025
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