ACTIVE_NOT_RECRUITING

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

Conditions

Heart Failure Acute Decompensated Heart Failure

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2022-04-20

Study Completion:2028-03

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05291884

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

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

Inclusion Criteria

Exclusion 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

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

Contacts and Locations

Principal Investigator

David D'Alessandro, MD

PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Jane Wilcox, MD MSc

PRINCIPAL_INVESTIGATOR

Northwestern University Hospital

Study Locations (Sites)

Emory University Hospital

Atlanta, Georgia, 30322

United States

Northwestern University

Evanston, Illinois, 60208

United States

Tufts Medical Center

Boston, Massachusetts, 02111

United States

Massachusetts General Hospital

Boston, Massachusetts, 02114

United States

Hackensack University Medical Center

Hackensack, New Jersey, 07601

United States

Cleveland Clinic

Cleveland, Ohio, 44195

United States

Collaborators and Investigators

Sponsor: Abiomed Inc.

David D'Alessandro, MD, PRINCIPAL_INVESTIGATOR, Massachusetts General Hospital
Jane Wilcox, MD MSc, PRINCIPAL_INVESTIGATOR, Northwestern University Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-04-20

Study Completion Date2028-03

Study Record Updates

Study Start Date2022-04-20

Study Completion Date2028-03

Terms related to this study

Additional Relevant MeSH Terms

Heart Failure
Acute Decompensated Heart Failure