BioCardia to present design trial for Phase III CardiAMP Heart Failure Trial
BioCardia announced that the trial design for its pivotal Phase III CardiAMP Heart Failure Trial will be presented tomorrow during the "Heart Failure: The Big Target for CV Regenerative Therapy State of the Field" session at the Texas Heart Institute International Symposium on Cardiovascular Regenerative Medicine in Houston. As an invited faculty member for the meeting, Professor of Cardiovascular Medicine at the University of Florida and Study Co-National Principal Investigator Carl Pepine, MD is presenting the design. The CardiAMP Heart Failure Trial is a Phase III, multi-center, randomized, double-blinded, sham-controlled study at 40 centers nationwide of up to 260 patients, which includes a 10-patient roll-in cohort. The trial's primary endpoint is an improvement in six-minute walking distance at 12 months' post-treatment. In addition, the primary endpoint analysis incorporates the impact of major adverse cardiac events and other clinically meaningful events. Earlier CardiAMP studies - including the Phase II TAC-HFT-BMC trial - have shown an excellent safety profile with statistically significant improvements in patient quality of life and functional capacity. Delivery of stem cell therapy to the heart using the Helix transendocardial delivery system incorporated in CardiAMP therapy has been shown to result in superior cell delivery than either percutaneous intra-coronary infusion or direct injection in an open chest procedure.