Status:
ACTIVE_NOT_RECRUITING
Use of the Impella BTR™ in Patients With Heart Failure: An Early Feasibility Study
Lead Sponsor:
Abiomed Inc.
Conditions:
Heart Failure
Acute Decompensated Heart Failure
Eligibility:
All Genders
18+ years
Phase:
NA
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 e...
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 feasibilit...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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 \[Vulnerable subject populations are defined as individuals with mental disability, persons in nursing homes, children, impoverished persons, homeless persons, nomads, refugees and those permanently incapable of giving informed consent.\]
Key Trial Info
Start Date :
April 20 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2028
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT05291884
Start Date
April 20 2022
End Date
March 1 2028
Last Update
January 8 2026
Active Locations (6)
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1
Emory University Hospital
Atlanta, Georgia, United States, 30322
2
Northwestern University
Evanston, Illinois, United States, 60208
3
Tufts Medical Center
Boston, Massachusetts, United States, 02111
4
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114