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

Recruiting in Palo Alto (17 mi)

+5 other locations

Overseen byAmir Kaki, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Abiomed Inc.

No Placebo Group

Trial Summary

What is the purpose of this trial?

The Impella ECP EFS is a prospective, multicenter, single-arm, feasibility study evaluating the safety of the Impella ECP device in adult patients undergoing an elective or urgent high-risk percutaneous coronary intervention.

Research Team

Amir Kaki, MD

Principal Investigator

Ascension St. John Hospital

Chuck Simonton, MD

Principal Investigator

Abiomed Inc.

Seth Bilazarian, MD

Principal Investigator

Abiomed Inc.

Eligibility Criteria

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.

Inclusion Criteria

Age ≥ 18 years and ≤ 90 years

Subject has signed the informed consent

Scheduled for an elective or urgent high risk percutaneous coronary intervention with hemodynamic support

Exclusion Criteria

You have a known condition affecting the blood vessels in your aorta or have experienced a tear in your aorta.

Known contraindication to heparin (i.e., heparin-induced thrombocytopenia), contrast media or Study-required medication(s) (i.e., aspirin)

Platelet count <75k, bleeding diathesis, coagulopathy or unwilling to receive blood transfusions

See 13 more

Treatment Details

Interventions

Impella ECP (Mechanical Circulatory Support Device)

Trial OverviewThe 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.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Subjects receiving the Impella ECPExperimental Treatment1 Intervention