CardiAMP Heart Failure II Trial for Patients With Ischemic Heart Failure With Reduced Ejection Fraction
Recruiting now · Not applicable · Has a placebo group
Conditions studied: Ischemic Heart Failure
In brief
Concentrated autologous bone marrow mononuclear cells (ABM MNC) contain potentially therapeutic cell factors and past studies support therapeutic benefit to patients with cardiac diseases of acute myocardial infarction, ischemia, and heart failure when utilized as this study is designed. The purpose of the study is to determine the safety and efficacy of CardiAMP cell therapy system in patients with ischemic heart failure. It is a prospective, multi-center, randomized, controlled, patient and evaluator-blinded study comparing treatment with the CardiAMP cell therapy system to a control procedure with diagnostic catheterization.
Key facts
- Study ID
- NCT06258447
- Run by
- BioCardia, Inc.
- People needed
- 250
- Starts
- 2024-08-01
- Expected to finish
- 2029-04-01
- Last updated by the study team
- 2026-02-09
Who can join
Age: 21 and older, up to 90. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- New York Heart Association (NYHA) Class II or III
- 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
You may not qualify if…
- Selected study criteria as defined in the study protocol indicating that patient is not an optimal candidate for cardiac catheterization or intramyocardial delivery of autologous bone marrow mononuclear cells.
Where it is running
- Morton Plant Hospital - BayCare — Clearwater, Florida, United States (enrolling)
- Emory University — Atlanta, Georgia, United States (enrolling)
- Henry Ford Hospital — Detroit, Michigan, United States (enrolling)
- University of Wisconsin-Division of Cardiovascular Medicine — Madison, Wisconsin, United States (enrolling)
- Cleveland Clinic — Cleveland, Ohio, United States
Full record on ClinicalTrials.gov
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