Clinical Trial

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

Study acronym: BTR EFS
Active, Not Recruiting
View on ClinicalTrials.gov →
Summary
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.
Protocol Amendment History 5 amendments
This ClinicalTrials.gov record has been amended 5 times since 2022-03-18; most recent amendment 2026-01-06.
Status change: Recruiting → Active, Not Recruiting 2025-10-16
Status change: Not Yet Recruiting → Recruiting 2022-05-23
Trial Details
NCT Number NCT05291884
Lead Sponsor Abiomed Inc.
Conditions Heart Failure, Acute Decompensated Heart Failure
Enrollment 10 participants
Start Date 2022-04-20
Primary Completion 2027-12 (estimated)
Study Completion 2028-03 (estimated)
Updated on ClinicalTrials.gov 2026-01-08