Using the Impella BTR™ device for heart failure patients

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

This study is testing a new heart device called Impella BTR™ to see if it can safely help adults with severe heart failure recover or prepare for other treatments.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 10 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Abiomed Inc. (Industry-sponsored)
• Locations: 7 sites (Atlanta, Georgia and 6 other locations)
• Trial ID: NCT05291884 on ClinicalTrials.gov

What this trial studies

This early feasibility study evaluates the safety and effectiveness of the Impella BTR™ device in adult patients with acute decompensated heart failure requiring left-ventricular hemodynamic support. The device is implanted through a surgical procedure and aims to support patients either to recovery or to their next therapy. Participants will be monitored for 90 days post-implant to assess outcomes and document any adverse events. The study is designed to gather preliminary data on the feasibility of this innovative device.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with pre-existing heart failure classified as NYHA Class IV and experiencing acute heart failure.

Not a fit: Patients with structural aortic valve issues or those who have recently been diagnosed with heart failure may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option for patients with severe heart failure, potentially improving their recovery and quality of life.

How similar studies have performed: While this approach is innovative, similar studies using hemodynamic support devices have shown promise in improving outcomes for heart failure patients.

Eligibility criteria

Inclusion Criteria:

1. Age ≥18 years
2. Subject has signed the Informed Consent
3. Subject has pre-existing heart failure, with NYHA Class IV prior to the index admission
4. 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:

1. Structural aortic valve regurgitation or stenosis of any grade greater than mild, with evidence of aortic sclerosis on pre-procedure echocardiography
2. New diagnosis of heart failure ≤90 days prior to enrollment
3. Previous aortic valve replacement or reconstruction
4. Prealbumin \<150 mg/L (15 mg/dL) or Albumin \<30 g/L (3 g/dL)
5. Thrombus in the left atrium or ventricle
6. STEMI ≤30 days prior to enrollment
7. 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
8. 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.
9. Subjects with known aortic diseases
10. Any contraindication that precludes placing an Impella® including tortuous vascular anatomy, axillary artery diameter \<7 mm
11. Infection of the proposed procedural access site or suspected systemic active infection
12. Known contraindication to heparin (i.e., heparin induced thrombocytopenia (HIT)), pork, pork products, contrast media or study required medication(s)
13. Intolerance to anticoagulant or antiplatelet therapies
14. History of bleeding diathesis or known coagulopathy, any recent GU or GI bleed or will refuse blood transfusions
15. Known hemoglobin diseases, such as sickle cell anemia or thalassemia
16. Subject is currently on dialysis
17. History of heart transplant
18. Prior cardiac surgery ≤90 days prior to enrollment
19. RV dysfunction requiring mechanical or inotropic support pre-device implant
20. 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
21. Restrictive or obstructive cardiomyopathy, constrictive pericarditis, restrictive pericarditis, pericardial tamponade
22. Pre-existing liver dysfunction defined as: Child-Pugh Class B or C
23. Pre-existing pulmonary disease requiring home oxygen
24. Suspected or known pregnancy
25. 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
26. 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
27. 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
28. Subject belongs to a vulnerable population \[Vulnerable subject populations are defined as individuals with mental disability, persons in nursing homes, children, impoverished persons, homeless persons, nomads, refugees and those permanently incapable of giving informed consent.\]

Where this trial is running

Atlanta, Georgia and 6 other locations

• Emory University Hospital — Atlanta, Georgia, United States (Recruiting)
• Northwestern University — Evanston, Illinois, United States (Recruiting)
• Tufts Medical Center — Boston, Massachusetts, United States (Not_yet_recruiting)
• Massachusetts General Hospital — Boston, Massachusetts, United States (Active_not_recruiting)
• Hackensack University Medical Center — Hackensack, New Jersey, United States (Recruiting)
• Cleveland Clinic — Cleveland, Ohio, United States (Active_not_recruiting)
• Allegheny General Hospital — Pittsburgh, Pennsylvania, United States (Not_yet_recruiting)

Study contacts

• Principal investigator: David D'Alessandro, MD — Massachusetts General Hospital
• Study coordinator: Roberta (Bobbi) Bogaev, MD, FACP, FACC, FHFSA

Conditions Heart Failure; Acute Decompensated Heart Failure