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

Launched by ABIOMED INC. · Mar 18, 2022

Keywords

ClinConnect Summary

This clinical trial is investigating the use of a heart support device called the Impella BTR™ for adults experiencing severe heart failure. The main goals are to understand how safe the device is and how well it helps patients recover or prepares them for further treatment. The study is currently looking for participants who are at least 18 years old and have a serious form of heart failure, specifically those who are very weak and need immediate medical help.

To be eligible, participants must have been diagnosed with heart failure before this hospitalization and show specific signs of severe heart problems, such as very low blood pressure or difficulty pumping blood effectively. People with certain heart conditions, recent surgeries, or other significant health issues may not qualify for the study. If someone joins this trial, they can expect to receive close medical supervision while using the Impella BTR™ device and will be contributing to important research that could help improve treatments for serious heart conditions in the future.

Gender

ALL

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 \[Vulnerable subject populations are defined as individuals with mental disability, persons in nursing homes, children, impoverished persons, homeless persons, nomads, refugees and those permanently incapable of giving informed consent.\]