First-in-Man Study of a Cardiac Extracellular Matrix Hydrogel in Early and Late Myocardial Infarction Patients
oleh: Jay H. Traverse, MD, Timothy D. Henry, MD, Nabil Dib, MD, Amit N. Patel, MD, Carl Pepine, Gary L. Schaer, MD, Jessica A. DeQuach, PhD, Adam M. Kinsey, PhD, Paul Chamberlin, MD, Karen L. Christman, PhD
| Format: | Article |
|---|---|
| Diterbitkan: | Elsevier 2019-10-01 |
Deskripsi
Summary: This study evaluated the safety and feasibility of transendocardial injections of VentriGel, a cardiac extracellular matrix hydrogel, in early and late post–myocardial infarction (MI) patients with left ventricular (LV) dysfunction. VentriGel was delivered in 15 patients with moderate LV dysfunction (25% ≤ LV ejection fraction ≤ 45%) who were between 60 days to 3 years post-MI and were revascularized by percutaneous coronary intervention. The primary endpoints were incidence of adverse events and abnormal clinical laboratory results. This first-in-man study established the safety and feasibility of delivering VentriGel in post-MI patients, thus warranting further evaluation in larger, randomized clinical trials. Key Words: biomaterial, catheter, heart failure, injectable, myocardial infarction