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NCT02438306 · ClinicalTrials.gov registry record · Phase 3
CardiAMP™ Cell Therapy for Heart Failure Trial
A Phase 3 study, sponsored by BioCardia.
- Completed
- Registry status
- Phase 3
- Development phase
- 125
- Enrollment target
NCT02438306: Completed Phase 3 study, sponsored by BioCardia.
NCT02438306 is a Phase 3 study that has completed, run by BioCardia. The registered enrollment target is 125 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (84% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02438306, a Phase 3 study, has completed, sponsored by BioCardia.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 125 participants
- Enrollment target
Study Summary
This is a prospective, multi-center, randomized, controlled, patient- and evaluator-blinded study comparing treatment with the CardiAMP cell therapy to a sham control treatment. A roll-in phase with a maximum of 10 subjects may occur.
Primary Outcome
The tiers include (1) all-cause death, (2) non-fatal MACCE events, and (3) change for 6MWD from baseline to month 12.
Interventions
- OTHER Sham
- BIOLOGICAL Autologous cell therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 125 participants |
| Start Date | 2016-12 |
| Est. Completion | 2025-06 |
| Phase | Phase 3 |
What the finished NCT02438306 record still lists
NCT02438306 is an interventional study that assigns participants to a tested intervention. The registered 125 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (84% lower).
The record links to 0 conditions, and to 2 interventions - of which Sham is the first listed.
NCT02438306 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02438306 about?
NCT02438306 is a clinical study titled "CardiAMP™ Cell Therapy for Heart Failure Trial". This is a prospective, multi-center, randomized, controlled, patient- and evaluator-blinded study comparing treatment with the CardiAMP cell therapy to a sham control treatment. A roll-in phase with a maximum of 10 subjects may occur.
What is the current status of trial NCT02438306?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 125 participants. The study started on 2016-12. Estimated completion is 2025-06.
What interventions are being tested in trial NCT02438306?
The interventions under investigation include: Sham (OTHER), Autologous cell therapy (BIOLOGICAL).
Who is sponsoring clinical trial NCT02438306?
This trial is sponsored by BioCardia, which has 4 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02438306's enrollment target sits among peer trials
125 1605th of 2000 higher than 391 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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