Impella ECP Study (ECP Study) and Impella ECP Continued Access Protocol

NCT05334784 | Enrolling By Invitation DMC FDA Device

• 1 other identifier: ABMD-CIP-22-01
• Study Type: interventional
• Target: 856
• Locations: 1 country
• Sites: 32

Brief Summary

The Impella ECP Study is a prospective, multi-center, single-arm study evaluating the rate of major adverse cardiovascular and cerebrovascular events (MACCE) with the Impella ECP device in adult patients undergoing elective or urgent high-risk percutaneous coronary intervention. The above applies to Impella ECP Continued Access Protocol

Conditions

High-Risk Percutaneous Coronary Intervention

Keywords

HRPCI; High-risk percutaneous coronary intervention; Circulatory support; Left ventricular unloading; Abiomed; Impella; Impella ECP; Impella ECP CAP

Outcome Measures

Primary Outcomes (3)

• Rate of MACCE

  The rate of major adverse cardiovascular and cerebrovascular events (MACCE)

  Device Delivery through 30 Days

• Impella ECP-related major vascular complications (Safety Endpoint 1)

  Impella ECP-related major vascular complications

  From the Date of Device Delivery through Date of Discharge (assessed up to 30 days)

• Impella ECP-related Major Bleeding (Safety Endpoint 2)

  Impella ECP-related Major Bleeding

  Device Delivery through Discharge from the Index Hospital Admission (assessed up to 30 days)

Secondary Outcomes (4)

• Number of Subjects with Major Hemolysis

  Device Delivery through Discharge (assessed up to 30 days)

• Number of Subjects with Aortic Valve Injury

  Device Delivery through Discharge (assessed up to 30 days)

• Number of Subjects with Escalation of Care to Impella CP

  Device Removal through Discharge (assessed up to 30 days)

• Length of Hospital Stay for enrolled patients

  Admission through Discharge (assessed up to 30 days)

Study Arms (1)

Impella ECP Device

EXPERIMENTAL

Subjects receiving the Impella ECP.

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.

Impella ECP Device

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 signed the informed consent
• 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

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, significant (mRS\>2), 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
• 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 (32)

St. Joseph's Medical Center - Phoenix

Phoenix, Arizona, 85013, United States

Location

Pima Heart & Vascular

Tucson, Arizona, 85712, United States

Location

Arkansas Heart Hospital

Little Rock, Arkansas, 72211, United States

Location

Adventist Health Glendale

Glendale, California, 91206, United States

Location

Keck Hospital of USC

Los Angeles, California, 90033, United States

Location

Loma Linda University Medical Center

San Bernardino, California, 92354, United States

Location

Manatee Memorial Hospital

Bradenton, Florida, 34208, United States

Location

North Florida Regional Medical Center

Gainesville, Florida, 34208, United States

Location

AdventHealth - Tampa

Tampa, Florida, 33613, United States

Location

Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

Ochsner Foundation Hospital

New Orleans, Louisiana, 70121, United States

Location

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

Ascension St. John Hospital

Detroit, Michigan, 48236, United States

Location

Spectrum Health

Grand Rapids, Michigan, 49503, United States

Location

St. Cloud (CentraCare)

Saint Cloud, Minnesota, 56303, United States

Location

Providence St. Patrick

Missoula, Montana, 59802, United States

Location

Hackensack University Medical Ctr

Hackensack, New Jersey, 07601, United States

Location

Morristown Medical Center

Morristown, New Jersey, 07960, United States

Location

The Valley Hospital

Ridgewood, New Jersey, 07450, United States

Location

New Mexico Heart Institute

Albuquerque, New Mexico, 87102, United States

Location

Buffalo General

Buffalo, New York, 14203, United States

Location

CUMC/ New York Presbyterian Hospital

New York, New York, 10032, United States

Location

Lenox Hill Hospital

New York, New York, 10075, United States

Location

Oklahoma Heart Hospital - South

Oklahoma City, Oklahoma, 73135, United States

Location

Providence St. Vincent Med Center

Portland, Oregon, 97225, United States

Location

TriStar Centennial Medical Center

Nashville, Tennessee, 37203, United States

Location

Texas Health Presbyterian Hospital Dallas

Dallas, Texas, 75231, United States

Location

Baylor Scott & White The Heart Hospital Plano

Plano, Texas, 75093, United States

Location

Methodist Hospital - San Antonio

San Antonio, Texas, 78229, United States

Location

Sentara Norfolk Health System

Norfolk, Virginia, 23507, United States

Location

West Virginia University Hospital

Morgantown, West Virginia, 26506, United States

Location

Study Officials

• Navin Kapur, MD

  Abiomed Inc.

  STUDY DIRECTOR

• Seth Bilazarian, MD

  Abiomed Inc.

  STUDY DIRECTOR

• Amir Kaki, MD

  Ascension St. John Hospital

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: Upon completion of enrollment in the pivotal study, enrollment in Continued Access Protocol will begin. ECP Pivotal enrolled 256 subjects and Impella ECP Continued Access Protocol anticipates to enroll up to 600 subjects

Study Record Dates

• First Submitted: March 28, 2022
• First Posted: April 19, 2022
• Study Start: December 20, 2022
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 5, 2026

Record last verified: 2026-03

Locations

US (32)