Impella ECP Early Feasibility Study

NCT04477603 | Active Not Recruiting FDA Device

• 1 other identifier: TMF-VV-17471
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

High-risk Percutaneous Coronary Intervention

Keywords

HRPCI; High-risk percutaneous coronary intervention; circulatory support; left ventricular unloading; Abiomed; Impella; Impella ECP

Outcome Measures

Primary Outcomes (2)

• Feasibility: successful hemodynamic support

  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

  The rate of composite Major Device-Related Adverse Events

  through end of procedure, 1 day

Secondary Outcomes (4)

• Technical Success

  through end of procedure, 1 day

• Procedural Success

  through end of procedure, 1 day

• Rate of each individual Major Device-Related Adverse Event

  through end of study, 30 days

• Rate of composite Major Device-Related Adverse Events

  through end of study, 30 days

Study Arms (1)

Subjects receiving the Impella ECP

EXPERIMENTAL

Device: Impella ECP

Interventions

Impella ECP DEVICE

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.

Subjects receiving the Impella ECP

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Aortic valve disease that is anticipated to be prohibitive to Impella ECP crossing, including greater than mild aortic stenosis
• Previous aortic valve replacement or reconstruction
• Thrombus in left ventricle
• Subjects with known aortic vessel disease or with aortic dissection
• Any contraindication that precludes placing an Impella including aortic, iliac or femoral disease such as tortuosity, extensive atherosclerotic disease or stenosis
• 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
• 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
• Infection of the proposed procedural access site or suspected systemic active infection, including any fever
• 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
• 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
• Subject is on dialysis
• Suspected or known pregnancy
• 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
• 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

Sponsors & Collaborators

• Abiomed Inc.: lead

Study Sites (5)

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

Henry Ford Health St. John Hospital

Detroit, Michigan, 48236, United States

Location

The Valley Hospital

Paramus, New Jersey, 07652, United States

Location

The Christ Hospital

Cincinnati, Ohio, 45219, United States

Location

Study Officials

• Amir Kaki, MD

  Ascension St. John Hospital

  PRINCIPAL INVESTIGATOR

• Seth Bilazarian, MD

  Abiomed Inc.

  STUDY DIRECTOR

• Navin Kapur, MD

  Abiomed Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2020
• First Posted: July 20, 2020
• Study Start: October 9, 2020
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): October 31, 2026
• Last Updated: April 14, 2026

Record last verified: 2026-04

Locations

US (5)