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

NCT06258447 | Recruiting DMC FDA Device

• 1 other identifier: 05804 (CLIN)
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 5

Brief Summary

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

Ischemic Heart Failure

Outcome Measures

Primary Outcomes (1)

• Primary Efficacy Endpoint

  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)

  Follow-up duration at endpoint analysis ranges from a minimum of 12 to a maximum of 24 months

Secondary Outcomes (7)

• First Secondary Endpoint

  Baseline through study completion, maximum of two years

• Second Secondary Endpoint

  Baseline through study completion, maximum of two years

• Third Secondary Endpoint

  Baseline through study completion, maximum of two years

• Fourth Secondary Endpoint

  Baseline to 12 months, 24 months

• Fifth Secondary Endpoint

  Baseline to 12 months, 24 months

Study Arms (2)

Study (ABM MNC) Treatment

EXPERIMENTAL

Left ventricular catheterization with treatment consisting of autologous bone marrow mononuclear cells (ABM MNC) processed and delivered using the CardiAMP cell therapy system

Device: Autologous bone marrow mononuclear cells processed / delivered using the CardiAMP cell therapy system

Control Treatment

SHAM COMPARATOR

Left ventricular (diagnostic) catheterization but no administration of ABM MNC

Device: Autologous bone marrow mononuclear cells processed / delivered using the CardiAMP cell therapy system

Interventions

Autologous bone marrow mononuclear cells processed / delivered using the CardiAMP cell therapy system DEVICE

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; Study (ABM MNC) Treatment

Eligibility Criteria

• Age: 21 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• BioCardia, Inc.: lead

Study Sites (5)

Morton Plant Hospital - BayCare

Clearwater, Florida, 33756, United States

RECRUITING

Emory University

Atlanta, Georgia, 30322, United States

RECRUITING

Henry Ford Hospital

Detroit, Michigan, 48202, United States

RECRUITING

Cleveland Clinic

Cleveland, Ohio, 44195, United States

WITHDRAWN

University of Wisconsin-Division of Cardiovascular Medicine

Madison, Wisconsin, 53792, United States

RECRUITING

Study Officials

• Amish Raval, MD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Debby Holmes-Higgin, MS, MPH

CONTACT

650-226-0120; debbyhh@biocardia.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blind including study participants and care provider (investigator) conducting outcomes assessments
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Controlled study of study treatment consisting of intramyocardial autologous cell injections compared to sham control, both performed in cardiac catheterization

Study Record Dates

• First Submitted: February 6, 2024
• First Posted: February 14, 2024
• Study Start: August 1, 2024
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2029
• Last Updated: February 9, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)