A Randomized, Controlled Study to Evaluate Algisyl-LVR™ as a Method of Left Ventricular Augmentation for Heart Failure
Status:
Completed
Trial end date:
2016-05-01
Target enrollment:
Participant gender:
Summary
This is a pilot study to evaluate the safety and efficacy of the Algisyl-LVR™ device. The
purpose of this study is to investigate Algisyl-LVR™ employed as a method of left ventricular
augmentation and restoration in patients with dilated cardiomyopathy. Algisyl-LVR™ will be
injected into the myocardium under direct visualization during the surgical procedure.
This study will evaluate the concept that direct mid left ventricular (LV) intramyocardial
injections of Alginate hydrogel implants into the free wall of the failing LV will reduce LV
size, restore LV shape, lower LV wall stress and improve global LV function.
The Primary Efficacy Endpoint of the study is the change in Peak VO2 (maximum oxygen uptake)
from baseline to 6 months of follow-up. The Primary Safety Endpoint of the study is to
estimate the 30 day mortality associated with the implantation of the Algisyl-LVR device
The hypothesis of the study is that there is a statistically significant difference in change
in Peak VO2 from baseline to 6 month follow-up when the medically managed arm is compared to
the Algisyl-LVR arm, i.e. the Algisyl LVR arm is superior to medical management.