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Impella®-Supported PCI in High-Risk Patients With Complex Coronary Artery Disease and Reduced Left Ventricular Function
NCT04763200 · View on ClinicalTrials.gov ↗
Study Summary
The purpose of this study is to assess if using the Impella® CP (or Impella® 2.5) device during high-risk PCI in patients with reduced left-sided heart function will result in an improvement in symptoms, heart function and health after a heart procedure compared to the current standard of care.
Conditions Studied
Interventions
- DEVICE Impella CP® / Impella CP® with SmartAssist® / Impella 2.5®
- DEVICE IABP Intra-aortic balloon pump
Study Locations (20)
California
- Adventist Health Glendale — Glendale
- St. Joseph Hospital - Orange — Orange
- Loma Linda University Health — San Bernardino
- UCSD Medical Center — San Diego
Illinois
- Rush University Medical Center — Chicago
- NorthShore University Health System — Evanston
- Northwestern University — Evanston
- Advocate Christ Medical Center — Oak Lawn
Florida
- The Cardiac & Vascular Institute — Gainesville
- University of Florida Health - Gainesville — Gainesville
- UF Health Jacksonville — Jacksonville
Arizona
- St. Joseph's Medical Center - Phoenix — Phoenix
- Northwest Medical Center Tucson — Tucson
Georgia
- Emory University Hospital — Atlanta
- Northside Cardiovascular Institute — Lawrenceville
Alabama
- University of Alabama — Birmingham
Arkansas
- Arkansas Cardiology — Little Rock
Colorado
- Colorado Heart and Vascular — Lakewood
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,252 participants |
| Start Date | 2021-04-13 |
| Est. Completion | 2027-10 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04763200
The ClinicalTrials.gov registry entry for NCT04763200 describes a study currently listed as active not recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 1,252 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Abiomed, which has 37 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Coronary Artery Disease appearing as the primary indexed condition, and to 2 interventions — of which Impella CP® / Impella CP® with SmartAssist® / Impella 2.5® is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04763200 reports 20 study locations spanning 10 distinct geographic areas — top geographies include California, Illinois, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04763200 about?
NCT04763200 is a clinical study titled "Impella®-Supported PCI in High-Risk Patients With Complex Coronary Artery Disease and Reduced Left Ventricular Function". The purpose of this study is to assess if using the Impella® CP (or Impella® 2.5) device during high-risk PCI in patients with reduced left-sided heart function will result in an improvement in symptoms, heart function and health after a heart procedure compared to the current standard of care.
What is the current status of trial NCT04763200?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 1,252 participants. The study started on 2021-04-13. Estimated completion is 2027-10.
What conditions does trial NCT04763200 study?
This clinical trial studies the following conditions: Coronary Artery Disease, Left Ventricular Dysfunction. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04763200?
The interventions under investigation include: Impella CP® / Impella CP® with SmartAssist® / Impella 2.5® (DEVICE), IABP Intra-aortic balloon pump (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04763200?
This trial is sponsored by Abiomed, which has 37 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04763200 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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