Impella ECP Study (ECP Study) and Impella ECP Continued Access Protocol
NCT ID: NCT05334784
Last Updated: 2025-09-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
NA
856 participants
INTERVENTIONAL
2022-12-20
2026-12-31
Brief Summary
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The above applies to Impella ECP Continued Access Protocol
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Detailed Description
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Investigational device products include: Impella ECP pump system (a percutaneous transvalvular micro-axial blood pump), 9Fr introducer sheath, and the automated Impella controller (AIC) with revised console software to allow control of the Impella ECP.
Study flow: 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. Subjects will undergo Impella ECP placement through a femoral sheath, following crimping of the Impella ECP. The intended coronary intervention will be performed with the mechanical circulatory support provided by the Impella ECP. Once the procedure is completed, the device is weaned and removed. Subjects will be followed for 30 days. Subjects will be treated based on the contemporary AHA/ACC/SCAI practice guidelines throughout the duration of the Study.
A sample size of two hundred seventeen (217) subjects with 30-day follow-up is needed for 90% power at a one-sided 0.05 significance level. Assuming 15% loss-to-follow-up, up to two hundred fifty-six (256) subjects will be enrolled. Safety endpoints will be presented as summary statistics without formal hypothesis testing. The MACCE rate will be assessed against the PG of 24.4% at one-sided 5% significance level.
Impella ECP Continued Access Protocol:
Description, Investigational device and study flow remains the same as above.
A sample size up to six hundred (600) subjects will be enrolled at up to 25 sites. Sites must have been activated in the Pivotal to be eligible for the Continued Access Protocol.
Conditions
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Study Design
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NA
SINGLE_GROUP
ECP Pivotal enrolled 256 subjects and Impella ECP Continued Access Protocol anticipates to enroll up to 600 subjects
TREATMENT
NONE
Study Groups
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Impella ECP Device
Subjects receiving the Impella ECP.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
2. Subject signed the informed consent
3. 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
Exclusion Criteria
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, 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
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
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 \[Vulnerable subject populations are defined as individuals with mental disability, persons in nursing homes, children, impoverished persons, homeless persons, nomads, refugees and those permanently incapable of giving informed consent. Vulnerable populations also may include members of a group with a hierarchical structure such as university students, subordinate hospital and laboratory personnel, employees of the Sponsor, members of the armed forces and persons kept in detention\]
18 Years
90 Years
ALL
No
Sponsors
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Abiomed Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Navin Kapur, MD
Role: STUDY_DIRECTOR
Abiomed Inc.
Seth Bilazarian, MD
Role: STUDY_DIRECTOR
Abiomed Inc.
Amir Kaki, MD
Role: PRINCIPAL_INVESTIGATOR
Ascension St. John Hospital
Locations
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St. Joseph's Medical Center - Phoenix
Phoenix, Arizona, United States
Pima Heart & Vascular
Tucson, Arizona, United States
Arkansas Heart Hospital
Little Rock, Arkansas, United States
Adventist Health Glendale
Glendale, California, United States
Keck Hospital of USC
Los Angeles, California, United States
Loma Linda University Medical Center
San Bernardino, California, United States
Manatee Memorial Hospital
Bradenton, Florida, United States
North Florida Regional Medical Center
Gainesville, Florida, United States
AdventHealth - Tampa
Tampa, Florida, United States
Emory University Hospital
Atlanta, Georgia, United States
Ochsner Foundation Hospital
New Orleans, Louisiana, United States
Tufts Medical Center
Boston, Massachusetts, United States
Henry Ford Hospital
Detroit, Michigan, United States
Ascension St. John Hospital
Detroit, Michigan, United States
Spectrum Health
Grand Rapids, Michigan, United States
St. Cloud (CentraCare)
Saint Cloud, Minnesota, United States
Providence St. Patrick
Missoula, Montana, United States
Hackensack University Medical Ctr
Hackensack, New Jersey, United States
Morristown Medical Center
Morristown, New Jersey, United States
The Valley Hospital
Ridgewood, New Jersey, United States
New Mexico Heart Institute
Albuquerque, New Mexico, United States
Buffalo General
Buffalo, New York, United States
CUMC/ New York Presbyterian Hospital
New York, New York, United States
Lenox Hill Hospital
New York, New York, United States
Oklahoma Heart Hospital - South
Oklahoma City, Oklahoma, United States
Providence St. Vincent Med Center
Portland, Oregon, United States
TriStar Centennial Medical Center
Nashville, Tennessee, United States
Texas Health Presbyterian Hospital Dallas
Dallas, Texas, United States
Baylor Scott & White The Heart Hospital Plano
Plano, Texas, United States
Methodist Hospital - San Antonio
San Antonio, Texas, United States
Sentara Norfolk Health System
Norfolk, Virginia, United States
West Virginia University Hospital
Morgantown, West Virginia, United States
Countries
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Other Identifiers
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ABMD-CIP-22-01
Identifier Type: -
Identifier Source: org_study_id
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