CardiAMP Heart Failure II Trial for Patients With Ischemic Heart Failure With Reduced Ejection Fraction
NCT ID: NCT06258447
Last Updated: 2026-02-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
250 participants
INTERVENTIONAL
2024-08-01
2029-04-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Study (ABM MNC) Treatment
Left ventricular catheterization with treatment consisting of autologous bone marrow mononuclear cells (ABM MNC) processed and delivered using the CardiAMP cell therapy system
Autologous bone marrow mononuclear cells processed / delivered using the CardiAMP cell therapy system
the ABM MNC is obtained from the study patient via bone marrow aspiration in the hip and processed and delivered using the CardiAMP cell therapy system during the cardiac catheterization.
Control Treatment
Left ventricular (diagnostic) catheterization but no administration of ABM MNC
Autologous bone marrow mononuclear cells processed / delivered using the CardiAMP cell therapy system
the ABM MNC is obtained from the study patient via bone marrow aspiration in the hip and processed and delivered using the CardiAMP cell therapy system during the cardiac catheterization.
Interventions
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Autologous bone marrow mononuclear cells processed / delivered using the CardiAMP cell therapy system
the ABM MNC is obtained from the study patient via bone marrow aspiration in the hip and processed and delivered using the CardiAMP cell therapy system during the cardiac catheterization.
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of chronic ischemic left ventricular dysfunction secondary to myocardial infarction (MI) as described in the study protocol.
* Left ventricular ejection fraction \>20% and \<40%
* On stable evidence-based medical and device therapy for ischemic etiology heart failure per the ACC/AHA Heart Failure guidelines, for at least three (3) months prior to randomization.
* NTproBNP level of \>500 pg/ml
* Autologous cell analysis score consistent with study selection assessment
Exclusion Criteria
21 Years
90 Years
ALL
No
Sponsors
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BioCardia, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Amish Raval, MD
Role: PRINCIPAL_INVESTIGATOR
University of Wisconsin, Madison
Locations
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Morton Plant Hospital - BayCare
Clearwater, Florida, United States
Emory University
Atlanta, Georgia, United States
Henry Ford Hospital
Detroit, Michigan, United States
Cleveland Clinic
Cleveland, Ohio, United States
University of Wisconsin-Division of Cardiovascular Medicine
Madison, Wisconsin, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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05804 (CLIN)
Identifier Type: -
Identifier Source: org_study_id
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