Impella ECP Early Feasibility Study (ECP EFS)

August 11, 2023 updated by: Abiomed Inc.

Use of the Impella ECP in Patients Undergoing an Elective High-Risk Percutaneous Coronary Intervention: An Early Feasibility Study

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 high-risk percutaneous coronary intervention.

Study Overview

Status

Active, not recruiting

Intervention / Treatment

Detailed Description

This is a prospective, multicenter, single-arm, feasibility study evaluating the safety of the Impella ECP device in adult patients undergoing an elective high-risk percutaneous coronary intervention (HRPCI). Additionally, this study will evaluate the feasibility of placing the ECP pump across the aortic valve without the use of a guidewire and assess the ability of the pump to provide sufficient hemodynamic support during a HRPCI. Investigational device products include: Impella ECP pump system (a percutaneous transvalvular micro-axial blood pump), 9Fr introducer sheath, and the automated Impella controller with revised console software to allow control of the Impella ECP.

Following informed consent, subjects eligible for a HRPCI that meet all of the inclusion and none of the exclusion criteria will be enrolled into the study. The intended coronary intervention is then carried out under mechanical circulatory support by the Investigational Device. This device is inserted through a sheath that has been deployed through a femoral puncture, following crimping of the Impella ECP. After proper placement and wireless passage of the aortic valve, the device pumps blood from the left ventricle into the aorta. Once the interventional procedure is completed, the device is weaned and removed. Subjects will be followed up until 30 days post intervention.

The primary and secondary end points will be summarized and presented without formal statistical testing. Safety will be assessed by the rate of composite Major Device-Related Adverse Events, evaluated at the end of the HRPCI procedure. Feasibility is defined as the successful delivery, initiation and maintenance of sufficient hemodynamic support to increase in or maintenance the MAP at physiologic levels (> 60 mmHg), evaluated up to the end of procedure.

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • Tufts Medical Center
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Hospital
      • Detroit, Michigan, United States, 48236
        • Ascension St. John Hospital
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • The Christ Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age ≥ 18 years and ≤ 90 years
  2. Subject has signed the informed consent
  3. Scheduled for an elective or urgent high risk percutaneous coronary intervention with hemodynamic support

Exclusion Criteria:

  1. Aortic valve disease that is anticipated to be prohibitive to Impella ECP crossing, including greater than mild aortic stenosis
  2. Previous aortic valve replacement or reconstruction
  3. Thrombus in left ventricle
  4. Subjects with known aortic vessel disease or with aortic dissection
  5. Any contraindication that precludes placing an Impella including aortic, iliac or femoral disease such as tortuosity, extensive atherosclerotic disease or stenosis
  6. Prior stroke with any permanent neurologic deficit or any prior intracranial hemorrhage or any prior subdural hematoma or known intracranial pathology pre-disposing to intracranial bleeding, such as an arteriovenous malformation or mass
  7. 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
  8. Infection of the proposed procedural access site or suspected systemic active infection, including any fever
  9. Subject has previously been symptomatic with or hospitalized for COVID-19 unless he/she has been discharged (if hospitalized) and asymptomatic for ≥8 weeks and has returned to his/her prior baseline (pre-COVID) clinical condition
  10. Known contraindication to heparin (i.e., heparin-induced thrombocytopenia), contrast media or Study-required medication(s) (i.e., aspirin)
  11. Platelet count <75k, bleeding diathesis, coagulopathy or unwilling to receive blood transfusions
  12. Subject is on dialysis
  13. Suspected or known pregnancy
  14. Subject has other medical, social or psychological problems that, in the opinion of the Investigator, compromises the subject's ability to give written informed consent and/or to comply with study procedures
  15. Participation in the active treatment or follow-up phase of another clinical study of an investigational drug or device which has not reached its primary endpoint
  16. Subject belongs to a vulnerable population [Vulnerable subject populations are defined as individuals with mental disability, persons in nursing homes, children, impoverished persons, homeless persons, nomads, refugees and those permanently incapable of giving informed consent. Vulnerable populations also may include members of a group with a hierarchical structure such as university students, subordinate hospital and laboratory personnel, employees of the Sponsor, members of the armed forces and persons kept in detention]

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Device Feasibility
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Subjects receiving the Impella ECP
Subjects will receive the Impella ECP prior to high-risk percutaneous intervention. Device escalation or early termination of the study will be allowed for subjects as deemed necessary by the treating physician. Subjects will be followed until 30-days post-intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility: successful hemodynamic support
Time Frame: through end of procedure, 1 day
The feasibility assessment is defined as the successful delivery, initiation and maintenance of sufficient hemodynamic support to increase in or maintenance the MAP at physiologic levels (> 60 mmHg)
through end of procedure, 1 day
Safety: Major Device-Related Adverse Events
Time Frame: through end of procedure, 1 day
The rate of composite Major Device-Related Adverse Events
through end of procedure, 1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Technical Success
Time Frame: through end of procedure, 1 day
The ability to complete the entire Impella ECP delivery procedure and pump initiation without device malfunction.
through end of procedure, 1 day
Procedural Success
Time Frame: through end of procedure, 1 day
Technical success with a sufficient flow generation by the pump in order to increase or maintain MAP during the interventional procedure.
through end of procedure, 1 day
Rate of each individual Major Device-Related Adverse Event
Time Frame: through end of study, 30 days
The rate of each individual Major Device-Related Adverse Event.
through end of study, 30 days
Rate of composite Major Device-Related Adverse Events
Time Frame: through end of study, 30 days
The rate of composite Major Device-Related Adverse Events.
through end of study, 30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Study Director: Chuck Simonton, MD, Abiomed Inc.
  • Principal Investigator: Duane Pinto, MD, Beth Israel Deaconess Medical Center
  • Study Director: Seth Bilazarian, MD, Abiomed Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 9, 2020

Primary Completion (Estimated)

September 30, 2023

Study Completion (Estimated)

December 31, 2023

Study Registration Dates

First Submitted

July 13, 2020

First Submitted That Met QC Criteria

July 17, 2020

First Posted (Actual)

July 20, 2020

Study Record Updates

Last Update Posted (Actual)

August 14, 2023

Last Update Submitted That Met QC Criteria

August 11, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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