To investigate patients suffering from iHF and a LVEF of equal or less than 40% despite best medical treatment safety and efficacy of a single retrograde intra-cardiac venous (i.cv.) injection of UA-ADRCs isolated from lipoaspirate at the point of care, using the Transpose® RT / Matrase System (InGeneron, Houston, TX, USA) through an over-the- wire, small balloon catheter, advanced through the coronary si-nus and located within a coronary vein at the site of inter-est, versus patients on best medical treatment.
Have documented coronary artery disease with evidence of myocardial injury, LV dysfunction, and clinical evidence of heart failure
Have an EF ≤40% by cardiac MRI
Be receiving guideline-driven medical therapy for heart failure at stable and tolerated doses for ≥1 month before consent
Be a candidate for right heart cardiac catheterization
Indication for standard-of-care surgery (including valve surgery, placement of LV assist device, or imminent heart transplantation), CABG procedure, and PCI. Candidates cannot be UNOS 1A or 1B, and they must have documented low probability of being transplanted.
PCI within 3 months of randomization
CABG within 3 months of randomization
Valvular heart disease including mechanical or bioprosthetic heart valve, severe valvular (any valve) insufficiency/regurgitation within 12 month of consent, and aortic stenosis with valve area ≤1.5 cm2
Ralf Rothoerl
Lead sponsor
ISAR Klinikum
Sponsor institution
National Scientific Medical Center, Kazakhstan
Collaborator
Internationnal Foundation Medicine and Science
Collaborator
Alliance of Cardiovascular Researchers
Collaborator