High-risk Percutaneous Coronary InterventionECP EFSNCT04477603
Impella ECP Early Feasibility Study
A study testing Impella ECP in people with High-risk Percutaneous Coronary Intervention, run by Abiomed Inc. at 5 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- High-risk Percutaneous Coronary Intervention
- What is being tested?
- Impella ECP
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 5 sitesUnited States
- Study dates
- 9 Oct 2020to 31 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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
- 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]
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Tufts Medical Center
Boston, Massachusetts, 02111
The Christ Hospital
Cincinnati, Ohio, 45219
Henry Ford Hospital
Detroit, Michigan, 48202
Henry Ford Health St. John Hospital
Detroit, Michigan, 48236
The Valley Hospital
Paramus, New Jersey, 07652
About this study
Official title: Use of the Impella ECP in Patients Undergoing an Elective or Urgent 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 or urgent high-risk percutaneous coronary intervention.
Read the 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 or urgent 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.
- Being tested
- Impella ECP
- Keywords
- HRPCI, High-risk percutaneous coronary intervention, circulatory support, left ventricular unloading, Abiomed, Impella, Impella ECP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Impella ECPDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Subjects receiving the Impella ECP | Experimental | Not described Receives: Device: Impella ECP |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: through end of procedure, 1 day
Safety: Major Device-Related Adverse Events
The rate of composite Major Device-Related Adverse Events
Measured: through end of procedure, 1 day
Secondary outcomes (4)
Technical Success
The ability to complete the entire Impella ECP delivery procedure and pump initiation without device malfunction.
Measured: through end of procedure, 1 day
Procedural Success
Technical success with a sufficient flow generation by the pump in order to increase or maintain MAP during the interventional procedure.
Measured: through end of procedure, 1 day
Rate of each individual Major Device-Related Adverse Event
The rate of each individual Major Device-Related Adverse Event.
Measured: through end of study, 30 days
Rate of composite Major Device-Related Adverse Events
The rate of composite Major Device-Related Adverse Events.
Measured: through end of study, 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2020
- Study start9 Oct 2020
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High-risk Percutaneous Coronary InterventionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abiomed Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Amir Kaki, MD, Principal investigator, Ascension St. John HospitalSeth Bilazarian, MD, Study director, Abiomed Inc.Navin Kapur, MD, Study director, Abiomed Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04477603
- Sponsor's protocol ID
- TMF-VV-17471
- Acronym
- ECP EFS
- Status last verified
- Jul 2026
- First submitted
- 13 Jul 2020
- Last updated
- 21 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of the Impella ECP in Patients Undergoing an Elective or Urgent High-Risk Percutaneous Coronary Intervention: An Early Feasibility Study
- ClinicalTrials.gov ID
- NCT04477603
- Acronym / sponsor ID
- ECP EFS / TMF-VV-17471
- Keywords
- HRPCI, High-risk percutaneous coronary intervention, circulatory support, left ventricular unloading, Abiomed, Impella, Impella ECP
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Abiomed Inc.Industry (pharma, biotech, devices)
- Study start
- 9 Oct 2020 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 20 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 or urgent 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 design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects receiving the Impella ECP | Experimental | Device: Impella ECP |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Impella ECPSubjects 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. | Device | Subjects receiving the Impella ECP |
Primary outcome
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)
Safety: Major Device-Related Adverse Events
Time frame: through end of procedure, 1 day
The rate of composite Major Device-Related Adverse Events
4 secondary outcomes
Technical Success
Time frame: through end of procedure, 1 day
Procedural Success
Time frame: through end of procedure, 1 day
Rate of each individual Major Device-Related Adverse Event
Time frame: through end of study, 30 days
Rate of composite Major Device-Related Adverse Events
Time frame: through end of study, 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amir Kaki, MD principal investigator
Ascension St. John Hospital
Seth Bilazarian, MD study director
Abiomed Inc.
Navin Kapur, MD study director
Abiomed Inc.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Impella ECP in people with High-risk Percutaneous Coronary Intervention, run by Abiomed Inc. at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility: successful hemodynamic support (time frame: through end of procedure, 1 day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.