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CardiAMP Heart Failure II Trial for Ischemic Heart Failure

This study is testing the safety and effectiveness of the CardiAMP cell therapy system for people with ischemic heart failure (heart failure caused by narrowed heart arteries) and a reduced ejection fraction (the heart's ability to pump blood). The CardiAMP system uses your own bone marrow cells, which are taken from your hip, processed, and then delivered to your heart during a procedure. You might be able to join if you are 21-90 years old, have specific types of heart failure (NYHA Class II or III), and your heart's pumping ability (left ventricular ejection fraction) is between 20% and 40%. The study will look at how well the treatment works over 12 to 24 months. The current status of this study is unclear.

Study design
This is a multi-center, randomized, controlled study with 250 participants. It is blinded, meaning neither you nor the evaluators will know if you received the treatment or a control procedure.
What's involved
If you are in the treatment group, you will have bone marrow taken from your hip and then undergo a heart catheterization procedure to deliver the cells.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for a minimum of 12 months and a maximum of 24 months after the procedure.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06258447

CardiAMP Heart Failure II Trial for Patients With Ischemic Heart Failure With Reduced Ejection Fraction

Recruiting
NAAges 21–90InterventionalTreatment
BioCardia, Inc.
~250 participants
Updated 2026-02-09 on ClinicalTrials.gov
What's tested:Autologous bone marrow mononuclear cells processed / delivered using the CardiAMP cell therapy system

At a glance

Recruiting sites
4 of 5 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Primary Efficacy Endpoint
Measured over Follow-up duration at endpoint analysis ranges from a minimum of 12 to a maximum of 24 months

Conditions

Ischemic Heart Failure

Explore related trials

Ischemic Heart FailureAutologous cell analysis score

NCT06258447

Where you'd take part

This study runs at 5 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Emory University

    Atlanta, Georgiastudy coordinator listed

    Recruiting

  • Henry Ford Hospital

    Detroit, Michiganstudy coordinator listed

    Recruiting

  • Morton Plant Hospital - BayCare

    Clearwater, Floridastudy coordinator listed

    Recruiting

  • University of Wisconsin-Division of Cardiovascular Medicine

    Madison, Wisconsinstudy coordinator listed

    Recruiting

  • Cleveland Clinic

    Cleveland, Ohiono site contact published

    Withdrawn

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Amish Raval, MD · PRINCIPAL_INVESTIGATOR · University of Wisconsin, Madison

Who to contact

Debby Holmes-Higgin, MS, MPH
[email protected]
650-226-0120
Email the study team

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Eligibility criteria

Inclusion

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

Exclusion

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.

What this trial measures

  • Primary Efficacy EndpointFollow-up duration at endpoint analysis ranges from a minimum of 12 to a maximum of 24 months

    The primary efficacy endpoint is the comparison of a composite score based on a 3-tiered Finkelstein-Schoenfeld (FS) hierarchical analysis. The tiers, starting with the most serious events, would be (1) all cause death, including cardiac death equivalents such as heart transplant or left ventricular assist device placement, ordered by time to event; (2) non-fatal MACCE events (heart failure hospitalization or a worsening heart failure, stroke or MI) ordered by time to event, excluding those deemed procedure related occurring within the first 7 days, and (3) change for quality of life as measured using the Minnesota Living with Heart Failure Questionnaire (MLwHFQ)