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

NCT05291884 | Active Not Recruiting FDA Device

• 1 other identifier: ABMD-CIP-21-01
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 6

Brief 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

Heart Failure; Acute Decompensated Heart Failure

Outcome Measures

Primary Outcomes (2)

• Feasibility: successful hemodynamic support

  The ability of the pump to provide clinically adequate support for the duration of the implant up to 28 days. Clinically adequate support is defined as operating without device malfunctions or failures that result in device removal, replacement or use of an additional MCS device.

  Device explant or 28 days, whichever is shorter

• Safety: Major Device-Related Adverse Events

  The rate of composite Major Device-Related Adverse Events

  From date of enrollment to 28 days or discharge from hospital

Secondary Outcomes (7)

• Number of participants with Major Hemolysis

  From date of enrollment to 28 days or discharge from hospital

• All-cause mortality

  From date of enrollment to 28 days or discharge from hospital & 90 days post-implant

• Stroke

  From date of enrollment to 28 days or discharge from hospital

• Device malfunction

  Device removal or up to 28 days

• Pump thrombus

  Device removal or up to 28 days

Study Arms (1)

Subjects receiving the Impella BTR

EXPERIMENTAL

Device: Impella BTR

Interventions

Impella BTR DEVICE

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.

Subjects receiving the Impella BTR

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years
• Subject has signed the Informed Consent
• Subject has pre-existing heart failure, with NYHA Class IV prior to the index admission
• Subject is presenting with acute heart failure and meets one of the following criteria:
• Sustained episode of systolic blood pressure ≤90 mmHg for at least 30 minutes or need for vasoactive agents to maintain such blood pressure
• Or a cardiac index (CI) \<2.2 L/min/m2 determined to be secondary to cardiac dysfunction, in the absence of hypovolemia
• Or required support with an intra-aortic balloon pump

You may not qualify if:

• Structural aortic valve regurgitation or stenosis of any grade greater than mild, with evidence of aortic sclerosis on pre-procedure echocardiography
• New diagnosis of heart failure ≤90 days prior to enrollment
• Previous aortic valve replacement or reconstruction
• Prealbumin \<150 mg/L (15 mg/dL) or Albumin \<30 g/L (3 g/dL)
• Thrombus in the left atrium or ventricle
• STEMI ≤30 days prior to enrollment
• Severe Cardiogenic Shock during index hospitalization - requiring multiple pressors, currently on mechanical circulatory support (not including IABP) or mechanical ventilation or experiencing PEA or refractory VT/VF
• Unwitnessed cardiac arrest OR ≥30 minutes of CPR prior to enrollment OR any cardiac arrest with impairment in mental status, cognition or any global or functional neurological deficit.
• Subjects with known aortic diseases
• Any contraindication that precludes placing an Impella® including tortuous vascular anatomy, axillary artery diameter \<7 mm
• Infection of the proposed procedural access site or suspected systemic active infection
• Known contraindication to heparin (i.e., heparin induced thrombocytopenia (HIT)), pork, pork products, contrast media or study required medication(s)
• Intolerance to anticoagulant or antiplatelet therapies
• History of bleeding diathesis or known coagulopathy, any recent GU or GI bleed or will refuse blood transfusions
• Known hemoglobin diseases, such as sickle cell anemia or thalassemia

Sponsors & Collaborators

• Abiomed Inc.: lead

Study Sites (6)

Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

Northwestern University

Evanston, Illinois, 60208, United States

Location

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• David D'Alessandro, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

• Jane Wilcox, MD MSc

  Northwestern University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2022
• First Posted: March 23, 2022
• Study Start: April 20, 2022
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): March 1, 2028
• Last Updated: January 8, 2026

Record last verified: 2026-01

Locations

US (6)