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NCT06258447 · ClinicalTrials.gov registry record · NA
CardiAMP Heart Failure II Trial for Patients With Ischemic Heart Failure With Reduced Ejection Fraction
A NA study of Ischemic Heart Failure, sponsored by BioCardia.
- Recruiting
- Registry status
- NA
- Development phase
- 250
- Enrollment target
- 5
- Study locations
NCT06258447: Recruiting NA study of Ischemic Heart Failure, sponsored by BioCardia.
NCT06258447 is a NA study of Ischemic Heart Failure that is actively recruiting participants, run by BioCardia. The registered enrollment target is 250 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (82% lower). The trial reports 5 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06258447, a NA study of Ischemic Heart Failure, is actively recruiting participants, sponsored by BioCardia.
- RECRUITING
- Registry status
- NA
- Development phase
- 250 participants
- Enrollment target
- 5
- Study locations
Study 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.
Primary Outcome
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 deem
Conditions Studied
Interventions
- DEVICE Autologous bone marrow mononuclear cells processed / delivered using the CardiAMP cell therapy system
Study Locations (5)
Florida
- Morton Plant Hospital - BayCare - Clearwater
Georgia
- Emory University - Atlanta
Michigan
- Henry Ford Hospital - Detroit
Ohio
- Cleveland Clinic - Cleveland
Wisconsin
- University of Wisconsin-Division of Cardiovascular Medicine - Madison
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 250 participants |
| Start Date | 2024-08-01 |
| Est. Completion | 2029-04-01 |
| Phase | NA |
What NCT06258447 shows while recruiting
NCT06258447 is an interventional study that assigns participants to a tested intervention. The registered 250 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (82% lower).
The record links to 1 condition, with Ischemic Heart Failure appearing as the primary indexed condition, and to 1 intervention - of which Autologous bone marrow mononuclear cells processed / delivered using the CardiAMP cell therapy system is the first listed.
NCT06258447 lists 5 locations in 5 states (Florida, Georgia, Michigan).
Frequently Asked Questions
What is clinical trial NCT06258447 about?
NCT06258447 is a clinical study titled "CardiAMP Heart Failure II Trial for Patients With Ischemic Heart Failure With Reduced Ejection Fraction". 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...
What is the current status of trial NCT06258447?
This trial is currently recruiting. It is a NA study. The enrollment target is 250 participants. The study started on 2024-08-01. Estimated completion is 2029-04-01.
What conditions does trial NCT06258447 study?
This clinical trial studies the following conditions: Ischemic Heart Failure.
What interventions are being tested in trial NCT06258447?
The interventions under investigation include: Autologous bone marrow mononuclear cells processed / delivered using the CardiAMP cell therapy system (DEVICE).
Who is sponsoring clinical trial NCT06258447?
This trial is sponsored by BioCardia, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06258447 being conducted?
This trial has 5 study locations across Florida, Georgia, Michigan, Ohio, Wisconsin. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06258447's enrollment target sits among peer trials
250 410th of 2000 higher than 1,568 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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