SHS_300345 HUAP CBCA 17109

Randomized Controlled Pivotal Trial of Autologous Bone Marrow Mononuclear Cells Using the CardiAMP Cell Therapy System in Patients With Post Myocardial Infarction Heart Failure (CardiAMP Heart Failure Trial)

Inclusion Criteria:

-New York Heart Association (NYHA) Class II or III
-A diagnosis of chronic ischemic left ventricular dysfunction secondary to myocardial infarction (MI).
-On stable evidence-based medical and device therapy for heart failure or post-infarction left ventricular dysfunction, per the 2013 ACC/AHA Heart Failure guidelines, for at least three (3) months prior to randomization.
-Left ventricular ejection fraction between 20% and 40%.

Exclusion Criteria:

-Other cardiac or vascular system or other health-related criteria which may be seen in a patient's history and physical examination.

Sexes Eligible for Study: All

Ages: 21 Years to 90 Years (Adult, Older Adult)

Accepts Healthy Volunteers: No
Phase III
NCT02438306
Heart and Vascular
Heart Failure
Paul Huang, M.D.
BioCardia, Inc.
  • Swedish Medical Center