US-based LoneStar Heart has completed the patient recruitment Phase of its AUGMENT-HF controlled randomized trial of its lead product Algisyl-LVR hydrogel implant for the treatment of advanced heart failure (HF).
The AUGMENT-HF clinical trial is being carried out at 14 centers in Italy, Germany, Romania, Australia, and The Netherlands and its six-month outcomes are expected to be reported by the end of 2014.
The trial is designed to determine if the product is superior to standard medical therapy in the management of patients with a dilated and weakened left ventricle and significantly deteriorated cardiac function.
LoneStar Heart president and chief operating officer Frank Ahmann said the company is grateful to all of its clinicians for their hard work and contributions for helping them reach this critical milestone.
"While patient follow-up will continue for two years, we look forward to presenting the primary endpoints in a few more months considering the potential for Algisyl-LVR to revolutionize the treatment of patients with advanced heart failure," Ahmann said.
Interim results of the trial showed left ventricle augmentation of the failing heart after implantation with Algisyl-LVR can be performed safely in patients with advanced heart failure and provides functional improvement in their health status.
The company said that extensive preclinical studies have shown Algisyl-LVR decreases cardiac wall tension, while it improves heart muscle contractility and oxygen uptake, leading to a decrease in ventricle stress and to a marked cardiomechanic improvement.
Algisyl-LVR, which is classified by the US FDA as a medical device, is intended to reverse HF progression in patients who have an enlarged left ventricle.