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

Abiomed

Status

Active, not recruiting

Conditions

Acute Decompensated Heart Failure

Heart Failure

Treatments

Device: Impella BTR

Study type

Interventional

Funder types

Industry

Identifiers

NCT05291884

ABMD-CIP-21-01

Details and patient eligibility

About

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.

Full 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.

Enrollment

10 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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:
1. Sustained episode of systolic blood pressure ≤90 mmHg for at least 30 minutes or need for vasoactive agents to maintain such blood pressure
2. Or a cardiac index (CI) <2.2 L/min/m2 determined to be secondary to cardiac dysfunction, in the absence of hypovolemia
3. Or required support with an intra-aortic balloon pump

Exclusion criteria

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
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.]