🏛️ Verified NIH Record • Updated 2026-04-09
Impella ECP Early Feasibility Study (NCT04477603)
Use of the Impella ECP in Patients Undergoing an Elective or Urgent High-Risk Percutaneous Coronary Intervention: An Early Feasibility Study
🔵 Active, Not Recruiting Observational / Diagnostic ⚙️ Medical Device Protocol Sponsor: Abiomed Inc.
🩺 Plain-English Summary (8th-Grade Level)
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 join: Review the eligibility criteria below.
Location: Tufts Medical Center — Boston, Massachusetts
Age range: 18 Years to 90 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (5 Sites)
- Tufts Medical Center — Boston, Massachusetts
- Henry Ford Hospital — Detroit, Michigan
- Henry Ford Health St. John Hospital — Detroit, Michigan
- The Valley Hospital — Paramus, New Jersey
- The Christ Hospital — Cincinnati, Ohio
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
Explore by condition: All High-risk Percutaneous Coronary Intervention clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.