Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Autologous cell therapy · 1 trial · 1 indication
The tiers include (1) all-cause death, (2) non-fatal MACCE events, and (3) change for 6MWD from baseline to month 12.
| Arm | Type | Description |
|---|---|---|
| CardiAMP cell therapy | EXPERIMENTAL | Placement of an introducer guidewire, performance of a left ventriculogram, and treatment with autologous cell therapy. |
| Sham Comparator | SHAM_COMPARATOR | Placement of an introducer guidewire and performance of a left ventriculogram with no autologous cell therapy treatment. |
| Name | Type | Description |
|---|---|---|
| Autologous cell therapy | BIOLOGICAL | Autologous cell therapy delivered into the heart muscle using the CardiAMP Cell Therapy System. The CardiAMP Cell Therapy System consists of the CardiAMP Cell Separator, a cardiac delivery catheter, and flexible tip guide catheter. |
| Sham | OTHER | An introducer guidewire is placed into the heart and left ventriculography is performed just like it is in the Experimental Arm but no autologous cell therapy is delivered. |
Inclusion Criteria: * New York Heart Association (NYHA) Class II or III * A diagnosis of chronic ischemic left ventricular dysfunction secondary to myocardial infarction (MI) as defined by selected criteria. * On stable evidence-based medical and device therapy for ischemic etiology heart failure, ...