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Heart FailureBTR EFSNCT05291884

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

A study testing Impella BTR in people with Heart Failure and Acute Decompensated Heart Failure, run by Abiomed Inc. at 6 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Impella BTR
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
6 sitesUnited States
Study dates
20 Apr 2022to Mar 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 28Show fewer
  • 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
  • Subject is currently on dialysis
  • History of heart transplant
  • Prior cardiac surgery ≤90 days prior to enrollment
  • RV dysfunction requiring mechanical or inotropic support pre-device implant
  • History of stroke or intracranial hemorrhage ≤90 days prior to enrollment, or a history of cerebrovascular disease with significant (> 80%) uncorrected carotid stenosis, or any permanent neurological deficit
  • Restrictive or obstructive cardiomyopathy, constrictive pericarditis, restrictive pericarditis, pericardial tamponade
  • Pre-existing liver dysfunction defined as: Child-Pugh Class B or C
  • Pre-existing pulmonary disease requiring home oxygen
  • Suspected or known pregnancy
  • Subject has previously been symptomatic with or hospitalized for COVID-19 unless he/she has been discharged (if hospitalized) and asymptomatic for ≥8 weeks and has returned to his/her prior baseline (pre-COVID) clinical condition
  • Subject has other medical, social or psychological problems that, in the opinion of the Investigator, compromises the subject's ability to give written informed consent and/or to comply with study procedures
  • Participation in the active treatment or follow-up phase of another clinical study of an investigational drug or device which has not reached its primary endpoint
  • Subject belongs to a vulnerable population [Vulnerable subject populations are defined as individuals with mental disability, persons in nursing homes, children, impoverished persons, homeless persons, nomads, refugees and those permanently incapable of giving informed consent.]

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

United States6 sites

  • Emory University Hospital

    Atlanta, Georgia, 30322

  • Tufts Medical Center

    Boston, Massachusetts, 02111

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Cleveland Clinic

    Cleveland, Ohio, 44195

  • Northwestern University

    Evanston, Illinois, 60208

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601

Other trials in United States

About this study

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.

Read the detailed description

The objectives of this Early Feasibility Study are to evaluate the safety of the Impella BTR™ in adult patients requiring left-ventricular hemodynamic support. Additionally, to evaluate the feasibility of the Impella BTR™ in supporting patients to recovery or their next therapy. The investigational device consists of the following primary device and accessories: The Impella BTR™ Pump System (an intravascular transvalvular, micro-axial blood pump) and the Modified Automated Impella Controller™ (AIC) to allow control of the Impella BTR.

Following informed consent, subjects that meet all of the inclusion and none of the exclusion criteria, and in whom the Impella BTR™ is implanted or attempted to be implanted, will be considered enrolled into the Study. The device is inserted during a surgical procedure through a vascular graft that has been sutured onto the left or right axillary artery. After proper placement and passage through the aortic valve with the help of a guidewire, the device pumps blood from the left ventricle into the aorta. Once hemodynamic support is no longer required, the device is weaned and removed. Subjects will be followed to 90 days post-implant.

The primary and secondary endpoints will be summarized and presented without formal statistical testing. All adverse events including all Protocol-defined events, serious and non-serious, will be documented and reported from the time of subject enrollment until Study completion. Feasibility is defined as 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.

Being tested
Impella BTR
Medical subject headings
Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Impella BTRDevice

    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.

Study groups in NCT05291884
Study groupRoleWhat they receive
Subjects receiving the Impella BTRExperimentalNot described
Receives: Device: Impella BTR

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Device explant or 28 days, whichever is shorter

  2. Safety: Major Device-Related Adverse Events

    The rate of composite Major Device-Related Adverse Events

    Measured: From date of enrollment to 28 days or discharge from hospital

Secondary outcomes (7)

  1. Number of participants with Major Hemolysis

    Measured: From date of enrollment to 28 days or discharge from hospital

  2. All-cause mortality

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

  3. Stroke

    Measured: From date of enrollment to 28 days or discharge from hospital

  4. Device malfunction

    That results in clinically inadequate support, not requiring removal, replacement or an additional device

    Measured: Device removal or up to 28 days

  5. Pump thrombus

    Measured: Device removal or up to 28 days

  6. Length of hospital stay

    Measured: From date of enrollment to 28 days or discharge from hospital

  7. Assessment of quality of life over baseline

    As measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ)

    Measured: Baseline to 90 days post-implant

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Mar 2022
  2. Study start20 Apr 2022
  3. Primary completionDec 2027 (estimated)
  4. Study completionMar 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Device feasibility
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05291884
Sponsor's protocol ID
ABMD-CIP-21-01
Acronym
BTR EFS
Status last verified
Jan 2026
First submitted
11 Feb 2022
Last updated
8 Jan 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Impella BTR in people with Heart Failure and Acute Decompensated Heart Failure, run by Abiomed Inc. at 6 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 8 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility: successful hemodynamic support (time frame: Device explant or 28 days, whichever is shorter). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05291884.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2026.

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