Actively Recruiting
CardiAMP Heart Failure II Trial for Patients With Ischemic Heart Failure With Reduced Ejection Fraction
Led by BioCardia, Inc. · Updated on 2026-02-09
250
Participants Needed
5
Research Sites
243 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
CardiAMP Heart Failure II Trial for Patients With Ischemic Heart Failure With Reduced Ejection Fraction
Who Can Participate
Eligibility Criteria
You may qualify if you...
- New York Heart Association (NYHA) Class II or III
- Diagnosis of chronic ischemic left ventricular dysfunction secondary to myocardial infarction
- Left ventricular ejection fraction greater than 20% and less than 40%
- On stable evidence-based medical and device therapy for ischemic heart failure for at least three months prior to randomization
- NTproBNP level greater than 500 pg/ml
- Autologous cell analysis score consistent with study selection assessment
You will not qualify if you...
- Patient is not an optimal candidate for cardiac catheterization or intramyocardial delivery of autologous bone marrow mononuclear cells as defined by the study protocol
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
Morton Plant Hospital - BayCare
Clearwater, Florida, United States, 33756
Actively Recruiting
2
Emory University
Atlanta, Georgia, United States, 30322
Actively Recruiting
3
Henry Ford Hospital
Detroit, Michigan, United States, 48202
Actively Recruiting
4
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Withdrawn
5
University of Wisconsin-Division of Cardiovascular Medicine
Madison, Wisconsin, United States, 53792
Actively Recruiting
Research Team
D
Debby Holmes-Higgin, MS, MPH
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here