Percutaneous endocardial alginate-hydrogel injection in the treatment of heart failure: First-in-human study.

ABSTRACT:

Aims

Despite the potential of alginate hydrogel intramyocardial injections in the treatment of heart failure (HF), minimally invasive implantation techniques remain scarce. This study evaluated the safety and feasibility of percutaneous transcatheter endocardial alginate hydrogel injection (TEAi), facilitated by novel implants and a dedicated catheter-based device, in patients with HF with reduced ejection fraction (HFrEF).

Methods and results

This first-in-human study enrolled HFrEF patients [New York Heart Association (NYHA) Class III-IV and left ventricular ejection fraction (LVEF) ≤35%]. The primary endpoint was the incidence of procedure- or device-related serious adverse events (SADEs) at 30 days. Secondary endpoints included the device success rate, HF hospitalization

SUBMITTER: Wang B 

PROVIDER: S-EPMC12719817 | biostudies-literature | 2025 Dec

REPOSITORIES: biostudies-literature