🏛️ Verified NIH Record • Updated 2026-01-06

Use of the Impella BTR™ in Patients With Heart Failure: An Early Feasibility Study (NCT05291884)

🔵 Active, Not Recruiting Observational / Diagnostic ⚙️ Medical Device Protocol Sponsor: Abiomed Inc.

🩺 Plain-English Summary (8th-Grade Level)

This is a prospective, multi-center, single-arm, early feasibility study that aims to evaluate the safety of the Impella BTR™ in adult patients requiring left-ventricular hemodynamic support, and to evaluate the effectiveness of the Impella BTR™ in supporting patients to recovery or their next therapy.

Who can join: Review the eligibility criteria below.

Location: Emory University Hospital — Atlanta, Georgia

Age range: 18 Years

🧪 Interventions in This Study

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria ↗

📍 All Participating Trial Locations (6 Sites)

  • Emory University Hospital — Atlanta, Georgia
  • Northwestern University — Evanston, Illinois
  • Tufts Medical Center — Boston, Massachusetts
  • Massachusetts General Hospital — Boston, Massachusetts
  • Hackensack University Medical Center — Hackensack, New Jersey
  • Cleveland Clinic — Cleveland, 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 Heart Failure clinical trials

💡 How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Review the official NIH record below to find the coordinating site.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
🏛️ View Official NIH Record ↗