BioCardia has announced a temporary halt to its Phase 3 pivotal CardiAMP Cell Therapy Heart Failure trial. This pause is to allow for the analysis of one-year follow-up outcomes for both treated patients and those who have been enrolled but not yet treated.
The trial's independent Data Safety Monitoring Board has completed a prespecified data review and has recommended the collection of additional blind data before proceeding. It is important to note that this pause is unrelated to any emergent safety concerns.
In addition to pausing new patient enrollment, the DSMB has also recommended postponing any potential crossover patient procedures until after the outcomes analysis has been conducted. Currently enrolled patients will be informed that the trial will be paused following their scheduled treatment, in order to evaluate intermediate study results.
The interim review, based on data from 132 procedures involving 111 randomized patients, including both treated patients and the control group, has provided promising results. The blinded data report, which includes all patients in the trial, demonstrates a higher survival rate at follow-up compared to recent similar large pivotal trials in patients with heart failure with reduced ejection fraction.
For more information, please visit BioCardia's website.