Impella ECP Early Feasibility Study (NCT04477603) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Impella ECP Early Feasibility Study
United States100 participantsStarted 2020-10-09
Plain-language 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.
Who can participate
Age range
18 Years – 90 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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
Exclusion criteria
. 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this is an early feasibility study for the Impella ECP device, what does that mean for how much is already known about its safety and effectiveness compared to existing heart support devices used during high-risk PCI?
2The trial is no longer enrolling new patients — does that affect whether this device or study results might still be relevant to my situation, and could my doctor access similar technology or an alternative study?
3One of the main things being measured is whether the device successfully provides hemodynamic support during the procedure — what does that mean in practice for my heart function, and what happens if the support isn't sufficient mid-procedure?
4What are the major device-related adverse events this study is watching for, and how do those risks compare to what I'd face having a high-risk PCI either without mechanical support or with a different support device?
5Given that this is a feasibility study still in early stages, would my doctor recommend waiting for more complete safety and outcome data before considering this approach, or is there a strong reason to consider it now for my specific situation?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.