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

NCT05291884 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2026-01-08

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

Impella BTR

Subjects will be prepared for pump insertion procedure according to clinical site standard of care. Procedural preparations for insertion of the Impella BTR are identical to the insertion of the Impella 5.0/5.5 via the axillary artery. The Impella BTR remains in situ until the patient is sufficiently recovered for removal or is transitioned to another form of support. It is expected that the Impella BTR is in situ for a maximum of 28 days.

Sponsors & Collaborators

  • Abiomed Inc.

    lead INDUSTRY

Principal Investigators

  • David D'Alessandro, MD · Massachusetts General Hospital

  • Jane Wilcox, MD MSc · Northwestern University Hospital

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-20
Primary Completion
2027-12-31
Completion
2028-03-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05291884 on ClinicalTrials.gov